OraSure Technologies, Inc. Annual Report 2022

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FY2022 Annual Report · OraSure Technologies, Inc.

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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 10-K

(Mark One)
"

ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, 2022
or

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from

Commission File No. 001-16537

ORASURE TECHNOLOGIES, INC.

(Exact name of registrant as specified in its charter)

Delaware
(State or other jurisdiction of
incorporation or organization)

220 East First Street
Bethlehem, Pennsylvania
(Address of principal executive offices)

36-4370966
(I.R.S. Employer
Identification No.)

18015
(Zip Code)

(Registrant’s telephone number, including area code): (610) 882-1820
Securities registered pursuant to Section 12(b) of the Act:

Title of Each Class
Common Stock, $0.000001 par value per share

Trading Symbol
OSUR

Name of Each Exchange on Which Registered
The Nasdaq Stock Market LLC

Securities registered pursuant to Section 12(g) of the Act: None

Indicate by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ! No "
Indicate by check mark if the Registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Exchange Act. Yes ! No "
Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934
during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days. Yes " No !

Indicate by check mark whether the Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of
Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit such files).
Yes " No !

Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an
emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”, “smaller reporting company” and “emerging growth company”
in Rule 12b-2 of the Exchange Act.
!
Large accelerated filer
!
Non-accelerated filer

Accelerated filer
Smaller reporting company
Emerging Growth Company

"
!
!

If an emerging growth company, indicate by check mark if the Registrant has elected not to use the extended transition period for complying with any

new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. !

Indicate by check mark whether the Registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal
control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C.7262(b)) by the registered public accounting firm that prepared or
issued its audit report. "

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the

filing reflect the correction of an error to previously issued financial statements. !

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation

received by any of the registrant's executive officers during the relevant recovery period pursuant to §240.10D-1(b). !

Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ! No "
State the aggregate market value of the voting and non-voting common equity held by non-affiliates, computed by reference to the price at which the

common equity was last sold, or the average bid and asked price of such common equity, as of the last business day of the Registrant’s most recently
completed second fiscal quarter (June 30, 2022): $197,743,692

Indicate the number of shares outstanding of each of the Registrant’s classes of common stock, as of February 24, 2023: 73,244,807 shares.

Documents Incorporated by Reference:

Part III of this Annual Report on Form 10-K will be incorporated by reference from certain portions of the Registrant's Definitive Proxy Statement for its

2023 Annual Meeting of Shareholders, or will be included in an amendment hereto, to be filed not later than 120 days after the close of the fiscal year ended
December 31, 2022. Except with respect to information specifically incorporated by reference in the Annual Report on Form 10-K, the Definitive Proxy
Statement is not deemed to be filed as part hereof.

Table of Contents

PART I

ITEM 1.

Business ..................................................................................................................................................................

ITEM 1A. Risk Factors ............................................................................................................................................................

ITEM 1B. Unresolved Staff Comments ...................................................................................................................................

ITEM 2.

Properties ................................................................................................................................................................

ITEM 3.

Legal Proceedings...................................................................................................................................................

ITEM 4. Mine Safety Disclosures .........................................................................................................................................

PART II

ITEM 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity

Securities.................................................................................................................................................................

ITEM 6.
Reserved..................................................................................................................................................................
ITEM 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.................................

ITEM 7A. Quantitative and Qualitative Disclosures About Market Risk................................................................................

ITEM 8.

Financial Statements and Supplementary Data ......................................................................................................

ITEM 9.

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure ................................

ITEM 9A. Controls and Procedures .........................................................................................................................................

ITEM 9B. Other Information ...................................................................................................................................................
ITEM 9C. Disclosure Regarding Foreign Jurisdictions That Prevent Inspections ..................................................................

PART III

ITEM 10. Directors, Executive Officers and Corporate Governance .....................................................................................

ITEM 11. Executive Compensation ........................................................................................................................................

ITEM 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters ..............

ITEM 13. Certain Relationships and Related Transactions, and Director Independence .......................................................

ITEM 14.

Principal Accountant Fees and Services .................................................................................................................

PART IV

ITEM 15. Exhibits and Consolidated Financial Statement Schedules ....................................................................................

ITEM 16.

Form 10-K Summary .............................................................................................................................................
Signatures................................................................................................................................................................

Page
1

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54

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69

Use of Names

References in this Annual Report on Form 10-K for the fiscal year ended December 31, 2022, (the "Annual Report") to "OraSure" mean
OraSure Technologies, Inc. References in this Annual Report to “DNAG” mean DNA Genotek, Inc., references to “Diversigen” mean
Diversigen, Inc., and references to “Novosanis” mean Novosanis NV. References in this Annual Report to "we", "us", "our", or the
"Company" mean OraSure and its consolidated subsidiaries, DNAG, Diversigen, and Novosanis, unless otherwise indicated.

Disclosure Regarding Forward Looking Statements

This Annual Report contains certain “forward-looking statements,” within the meaning of the Federal securities laws. These may
include statements about our expected revenues, earnings/losses per share, net income (loss), expenses, cash flow or other financial
performance, or developments, clinical trial or development activities, expected regulatory filings and approvals, planned business
transactions, views of future industry, competitive or market conditions, and other factors that could affect our future operations, results
of operations or financial position. These statements often include words, such as “believes,” “expects,” “anticipates,” “intends,”
“plans,” “estimates,” “may,” “will,” “should,” “could,” or similar expressions.

Forward-looking statements are not guarantees of future performance or results. Known and unknown factors that could cause actual
performance or results to be materially different from those expressed or implied in these statements include, but are not limited to:

•

Our ability to market and sell products, whether through our internal, direct sales force or third parties;

Our ability to fulfill our commitments under our contracts with the U.S. government for InteliSwab® COVID-19 Rapid Tests;

Failure of distributors or other customers to meet purchase forecasts, historic purchase levels or minimum purchase
requirements for our products;

Significant customer concentrations that exist or may develop in the future:

Our ability to manufacture products in accordance with applicable specifications, performance standards and quality
requirements;

Our ability to obtain, and timing and cost of obtaining, necessary regulatory approvals for new products or new indications
or applications for existing products; ability to comply with applicable regulatory requirements;

Our ability to effectively resolve warning letters, audit observations and other findings or comments from the U.S. Food
and Drug Administration (or the "FDA”), or other regulators;

The impact of the COVID-19 pandemic on our business, supply chain and workforce;

The impact of the U.S. government ending the COVID-19 related Public Health Emergency;

Changes in relationships, including disputes or disagreements, with strategic partners or other parties and reliance on
strategic partners for the performance of critical activities under collaborative arrangements;

Our ability to meet increased demand for our products;

The impact of replacing distributors on our business;

Inventory levels at distributors and other customers;

Our ability to achieve our financial and strategic objectives and continue to increase our revenues, including the ability to
expand international sales;

The impact of competitors, competing products and technology changes on our business;

Reduction or deferral of public funding available to customers;

Competition from new or better technology or lower cost products;

Our ability to develop, commercialize and market new products;

Market acceptance of oral fluid or urine testing, collection or other products;

Market acceptance and uptake of microbiome informatics, microbial genetics technology and related analytics services;

Changes in market acceptance of products based on product performance or other factors, including changes in testing
guidelines, algorithms or other recommendations by the Centers for Disease Control and Prevention, (the “CDC”) or other
agencies; ability to fund research and development and other products and operations;

Our ability to obtain and maintain new or existing product distribution channels;

Reliance on sole supply sources for critical products and components;

Availability of related products produced by third parties or products required for use of our products;

The impact of contracting with the U.S. government on our business;

The impact of negative economic conditions on our business;

Our ability to maintain sustained profitability;

Our ability to increase our gross margins;

The ability to utilize net operating loss carry forwards or other deferred tax assets;

Volatility of our stock price;

Uncertainty relating to patent protection and potential patent infringement claims;

•

Uncertainty and costs of litigation relating to patents and other intellectual property;

Availability of licenses to patents or other technology;

Ability to enter into international manufacturing agreements;

Obstacles to international marketing and manufacturing of products;

Our ability to sell products internationally, including the impact of changes in international funding sources and testing
algorithms;

Adverse movements in foreign currency exchange rates;

Loss or impairment of sources of capital;

Our ability to attract and retain qualified personnel;

Our exposure to product liability and other types of litigation;

Changes in international, federal or state laws and regulations;

Customer consolidations and inventory practices;

Equipment failures and ability to obtain needed raw materials and components;

The impact of terrorist attacks and civil unrest; and

General political, business and economic conditions, including inflationary pressures.

These and other factors that could affect our results are discussed more fully under Item 1A, entitled “Risk Factors,” and elsewhere in
this Annual Report. Although forward-looking statements help to provide information about future prospects, readers should keep in
mind that forward-looking statements may not be reliable. Readers are cautioned not to place undue reliance on the forward-looking
statements. The forward-looking statements and Risk Factors are made as of the date of this Annual Report and we undertake no duty
to update these statements, unless we are required to do so by law. If we do update one or more forward-looking statements, no inference
should be drawn that we will make updates with respect to other forward-looking statements or that we will make any further updates
to those forward-looking statements at any future time.

Investors should also be aware that while we do, from time to time, communicate with securities analysts, it is against our policy to
disclose any material non-public information or other confidential commercial information. Accordingly, stockholders should not
assume that we agree with any statement or report issued by any analyst irrespective of the content of the statement or report.
Furthermore, we have a policy against issuing or confirming financial forecasts or projections issued by others. Thus, to the extent that
reports issued by securities analysts contain any projections, forecasts or opinions, such reports are not the responsibility of OraSure.

Trademarks, Trade Names and Service Marks

This Annual Report contains certain trademarks, which are protected under applicable intellectual property laws and are the Company's
property. Solely for convenience, the Company's trademarks and trade names referred to in this Annual Report may appear without the
® or TM symbol, but such references are not intended to indicate, in any way, that the Company will not assert, to the fullest extent under
applicable law, its rights to these trademarks and trade names. We own rights to trademarks and service marks that we believe are
necessary to conduct our business as currently operated. In the United States, we own a number of trademarks, including the OraSure®,
Intercept®, Intercept i2® he, OraQuick®, OraQuick ADVANCE®, OraSure Quick Flu®, Q.E.D.®, InteliSwab®, Oragene®, DNA
Genotek®, OMNImetTM, ORAcollect®, OMNIgene®, goDNATM, Diversigen®, CoreBiome®, Boostershot®, MetaGeneTM, BenchmarkTM,
Novosanis®, Colli-Pee®, UCM®, UASTM, AUTO-LYTE®, prepIT®, and Hemagene® trademarks. We also own many of these marks and
others in several foreign countries and we are pursuing registration of several other trademarks.

PART I

ITEM 1.

Business.

Our primary goal is to empower the global community to improve health and wellness by providing access to accurate essential
information through effortless tests, collection kits and services. Our business previously consisted of two segments: our “Diagnostics”
segment, and our “Molecular Solutions” segment.

In February 2023, we announced a corporate restructuring to combine the commercial and innovation teams across the two segments
into one business unit with sales, marketing, product development and research teams covering multiple product lines. This change is
intended to accelerate innovation, enhance customer experience and result in operational synergies.

Diagnostics

Our Diagnostics business primarily consists of the development, manufacture, marketing and sale of simple, easy to use diagnostic
products and specimen collection devices using our proprietary technologies, as well as other diagnostic products including
immunoassays and other in vitro diagnostic tests that are used on other specimen types. The Diagnostics business includes tests for
diseases including COVID-19, HIV and Hepatitis C that are performed on a rapid basis at the point of care, and tests for drugs of abuse
that are processed in a laboratory. These products are sold in the United States and internationally to various clinical laboratories,
hospitals, clinics, community-based organizations, and other public health organizations, distributors, government agencies, physicians’
offices, and commercial and industrial entities. Our COVID-19 and HIV products are also sold in a consumer-friendly format in the
over-the-counter (“OTC”) market in the U.S. and, in the case of the HIV product, as a self-test to individuals in a number of other
countries. In 2022, after obtaining a CE mark, we launched our OraQuick® HIV Self-Test, an oral swab in-home test for HIV-1 and
HIV-2, in Europe, making it available in several European countries. Through our Diagnostics business we are also developing and
commercializing products that measure adherence to HIV medications including pre-exposure prophylaxis ("PrEP").

In September 2022, we entered into an agreement with the Biomedical Advanced Research Development Authority (“BARDA”),
pursuant to which BARDA will provide $8.6 million in funding to us to develop a 2nd generation Ebola test on the OraQuick® testing
platform, with the objective of developing increased sensitivity and shelf life, with new chemistry and higher degrees of automation in
the test’s manufacturing process.

Molecular Solutions

Our Molecular Solutions business is operated by our wholly-owned subsidiaries, DNA Genotek, Diversigen, and Novosanis. Our
Molecular Solutions business sells its products and services directly to its customers, primarily through its internal sales force in the
U.S. domestic market, and in many international markets, and also through distributors. Our products primarily consist of collection kits
and services used by clinical laboratories, direct-to-consumer laboratories, researchers, pharmaceutical companies, and animal health
service and product providers. Most of our Molecular Solutions revenues are derived from product sales to commercial customers and
sales into the academic and research markets. A significant portion of our total sales is from repeat customers in both markets. Molecular
Solutions customers span the disease risk management, diagnostics, pharmaceutical, biotech, nutrition, companion animal and
environmental markets.

In 2020, we expanded the market focus of our Molecular Solutions business by selling existing collection products for use with COVID-
19 tests. In 2022, demand for COVID-19 PCR testing declined, which was primarily driven by the availability of antigen tests, the
reduction in the numer of COVID-19 cases, and the wider availability of vaccines that negatively impacted the sales of the collection
products. We have also developed additional collection devices for the emerging microbiome market, which focuses on studying
microbiomes and their effect on human and animal health. In 2022, we launched the OMNIgene® • GUT Dx collection device (OMD-
200), which was granted De Novo authorization from the FDA for collection of human fecal samples and the stabilization of DNA from
the bacterial community for subsequent assessment of the microbiome profile by an assay validated for use with OMNIgene®·GUT Dx
device. Additionally, our OMNIgene® • GUT DNA and RNA collection device (OMR-205), became available to gut microbiome
researchers, allowing for self-collection, stabilization, storage and transportation of microbial DNA and RNA at ambient temperature
for gut microbiome profiling. We leverage our existing sales force and global research connections to engage microbiome customers
worldwide to establish ourselves among the leaders in ease-of-collection, stabilization, and transport of this challenging sample type.
Through our partnership with Grifols, we received FDA clearance for our ORAcollect®•Dx saliva collection device for OTC use, which
allows our commercial partners to use and market the device with their therapeutics or devices.

collaborations in the liquid biopsy and sexually transmitted disease markets. In 2022, Novosanis obtained a CE mark for its Colli-Pee®
device containing a prefilled tube with UAS® chemistry, which is designed to stabilize urinary analytes. Our Diversigen subsidiary also
offers laboratory and analytical services for both genomics and microbiome customers to more fully meet their needs. These services
are primarily provided to pharmaceutical, biotech companies, and research institutions.

In 2022, Diversigen launched its metatranscriptomics sequencing and analysis services for gut microbiome samples, which generate a
microbial community’s gene expression profile to provide information about the interactions between an individual and their
microbiome, creating a holistic picture of a sample’s microbial functions and expression levels.

Business Update Related to InteliSwab® Covid-19 Rapid Tests

In June 2021, we received three Emergency Use Authorizations ("EUA") from the FDA for our InteliSwab® COVID-19 Rapid Tests
(“InteliSwab®”) for non-prescription OTC, professional point-of-care use and prescription home use. We began recording revenues on
the sales of our InteliSwab® tests during the third quarter of 2021. In January 2022, InteliSwab® received FDA authorization for pediatric
use in children ages 2 to 14. In September 2021, the Defense Logistics Agency (“DLA”) awarded the Company a procurement contract
for the InteliSwab® tests for OTC use, which the DLA estimated to have a value of $205 million and which will provide InteliSwab®
tests to up to 20,000 sites throughout the United States. In 2022, the Company began to deliver tests to sites throughout the United
States under this contract, and DLA has provided delivery orders against which it can continue to issue shipping instructions into 2023.
On November 22, 2022, the DLA awarded us a second procurement contract for the InteliSwab® tests for OTC use. Under the terms of
the award, the contract estimate is 18 million tests, with a maximum award of 36 million tests and a guaranteed minimum award of 3.6
million tests. The contract will run from November 2022 through November 2023. In December 2022, the U.S. Department of Health
and Human Services ("HHS") awarded the Company a fully funded firm fixed price contract for a total of 3.2 million InteliSwab® tests
which were delivered in February 2023. In September 2021, we entered into an agreement with BARDA, which is part of the office of
the Assistant Secretary for Preparedness and Response at HHS, pursuant to which BARDA would provide the Company with up to
$13.6 million in funding to obtain clearance of a premarket notification ("510(k)") and Clinical Laboratory Improvement Amendments
of 1988 (“CLIA”) waiver of the InteliSwab® tests. In May, 2022, InteliSwab® was selected by HHS to be distributed across the United
States for nationwide school testing.

Through 2022, we have scaled up our operations to meet the increased demand for the InteliSwab® tests. We significantly expanded
our United States production capacity for InteliSwab® tests to achieve capacity targets, set out in our 2021 contract with the U.S.
Department of Defense ("DOD") (in coordination with the HHS), of more than 100 million tests annually.

Conclusion of Exploration of Strategic Alternatives

In 2021, our Board of Directors announced that it would explore and evaluate a broad range of strategic alternatives with the goal of
maximizing value for stockholders. In May, 2022, our Board of Directors concluded its review of strategic alternatives without a
transaction.

Diagnostics Products

The following is a summary of our principal Diagnostics products for the infectious disease and risk management markets:

InteliSwab® COVID-19 Rapid Test

InteliSwab® is our rapid immunoassay product designed to test nasal samples for the presence of antigen from SARS-CoV-2. The device
uses an integrated swab to collect a specimen from the lower nostril. After collection, the integrated swab is inserted into a vial containing
a pre-measured amount of developer solution to facilitate flow of the sample into the device. The specimen and developer solution flow
through the test device and test results are observable in 30 minutes. The InteliSwab® test has received EUA from the FDA for non-
prescription, OTC home use in individuals aged two years or older, with symptoms within the first seven (7) days of onset when tested
at least twice over a three-day period with at least 48 hours between tests and without symptoms or epidemiological reasons to suspect
COVID-19 when tested at least three times over a five-day period with at least 48 hours between tests.

In 2022, the InteliSwab® test became available for purchase on Amazon’s online store to customers in the United States. The tests are
sold and orders fulfilled by Amazon.

InteliSwab® COVID-19 Rapid Test Pro

The InteliSwab® COVID-19 Rapid Test Pro is a version of InteliSwab® intended for use by healthcare providers at the point of care. The
test is performed in the same manner as the OTC version, except that the test is run and interpreted by a healthcare provider. This test

has received EUA from the FDA for use by laboratories located in the United States certified under CLIA. We have also received a
CLIA waiver for use of the test, which enables the test to be used by numerous additional sites in the United States, which are not
certified under CLIA, to perform high and moderately complex tests. These additional sites include outreach clinics, community-based
organizations and physicians’ offices. This test is also indicated for individuals aged 2 years and older, with and without symptoms of
COVID-19.

InteliSwab® COVID-19 Rapid Test Rx

The InteliSwab® COVID-19 Rapid Test Rx is the version of InteliSwab® that has received EUA from the FDA for prescription home
use with individuals aged 2 years or older who are suspected of COVID-19 infection by their healthcare provider within the first seven
days of symptom onset.

OraQuick® Rapid HIV Test

The OraQuick® Rapid HIV Test is our rapid point-of-care test product designed to test oral fluid, whole blood (i.e., both finger-stick and
venous), plasma and serum samples for the presence of various antibodies. The device uses a porous flat pad to collect an oral fluid
specimen. After collection, the pad is inserted into a vial containing a pre-measured amount of developer solution and allowed to develop.
When blood, plasma or serum is to be tested, a loop collection device is used to collect a drop of the specimen and mix it in the developer
solution, after which the collection pad is inserted into the solution and allowed to develop. In all cases, the specimen and developer
solution then flow through the testing device where test results are observable in approximately 20 minutes. The OraQuick® device is a
screening test and requires a confirmation test where an initial positive result is obtained. This product is sold under the OraQuick
ADVANCE® name in North America, Europe and certain other countries and under the OraQuick® name in other developing countries.
The test has received approval of a premarket approval (“PMA”) application from the FDA for the detection of antibodies to both HIV-1
and HIV-2 in oral fluid, finger-stick whole blood, venous whole blood and plasma. This test is available for use by laboratories located
in the United States certified under CLIA, to perform moderately complex tests. We have also received a CLIA waiver for use of the
test with oral fluid and finger-stick and venous whole blood. As a result, the test can be used by numerous additional sites in the United
States not certified under CLIA to perform moderately complex tests, such as outreach clinics, community-based organizations and
physicians’ offices.

On the international front, we have obtained a CE mark for our OraQuick ADVANCE® test so that we can sell this product in Europe
and other countries accepting the CE mark for commercialization and this product is registered for sale in other countries. We have
distributors in place for several countries and are seeking to increase awareness and expand our distribution network for this product
throughout the world. We have also received World Health Organization (“WHO”) pre-qualification for our export-only version of this
product.

OraQuick® In-Home HIV Test

The OraQuick® In-Home HIV test is an OTC oral-fluid only version of our OraQuick ADVANCE® HIV 1/2 Antibody Test. We received
PMA approval to sell this test in the U.S. OTC market. The In-Home test is performed in the same manner as the OraQuick ADVANCE®
test, except that it has product labeling and instructions designed for consumers. In addition, we have established toll-free, 24/7, 365-
day per year customer telephone support to provide additional information and referral services for consumers that use this product.

OraQuick® HIV Self-Test

The OraQuick® HIV Self-Test is sold for use by individuals in certain foreign countries, including under the CE mark in certain European
countries, to meet the needs of those markets. This product has received WHO pre-qualification and is eligible for procurement by
purchasing entities entitled to access funding and other resources from the Global Fund, UNITAID and other agencies.

OraQuick® HCV Rapid Antibody Test

Another test available on the OraQuick® platform is the OraQuick® HCV rapid antibody test. This product is a qualitative test that can
detect antibodies to the hepatitis C virus (“HCV”), in a variety of sample types. The OraQuick® HCV test operates in substantially the
same manner as the OraQuick ADVANCE®HIV test.

We have received FDA PMA approval and CLIA waiver for use of the test in detecting HCV antibodies in venous whole blood and
finger-stick whole blood specimens, making it the first and only rapid HCV test approved by the FDA for use in the United States. The
OraQuick® HCV test has received a CE mark for use with oral fluid, venous whole blood, finger-stick whole blood, plasma and serum
and is sold in Europe. This CE-marked product is also registered and sold in other foreign countries and has received WHO pre-
qualification.

OraQuick® Ebola Rapid Antigen Test

We have received 510(k) clearance from the FDA for our rapid Ebola test, making it the first and only rapid Ebola test cleared for sale
in the U.S. This product utilizes the OraQuick® technology platform for the detection of Ebola antigen and can be used with finger-stick
and whole blood samples from live patients and oral fluid samples from recently deceased individuals. The uses for this test are limited
to individuals that meet certain criteria indicating they may be infected with the Ebola virus, so the test is not available for general
screening of individuals that do not meet this criteria.

In September 2022, we entered into an agreement with BARDA, pursuant to which BARDA will provide up to $8.6 million in funding
to us to develop a 2nd generation Ebola test on the OraQuick® testing platform.

OraSure® Collection Device

Our OraSure® oral fluid collection device is used in conjunction with screening and confirmatory tests for HIV-1 antibodies. The generic
version of this product can be used for other analytes. This device consists of a small, treated cotton-fiber pad on a handle that is placed
in a person’s mouth for two to five minutes. The device collects oral mucosal transudate, a serum-derived fluid that contains higher
concentrations of certain antibodies and analytes than saliva. As a result, oral mucosal transudate testing is a highly accurate method for
detecting HIV-1 infection and other analytes.

The OraSure® collection device is FDA approved for use in the detection of HIV-1 antibodies. The generic version is a Class I medical
device for the detection of cocaine and cotinine in oral fluid specimens for risk assessment testing. HIV-1 antibody detection using the
OraSure® collection device involves three steps:

•

Collection of an oral fluid specimen using the OraSure® device;

Screening of the specimen for HIV-1 antibodies at a laboratory with an enzyme immunoassay (“EIA”) screening test
approved by the FDA for use with the OraSure® device; and

Laboratory confirmation of any positive screening test results with a blood-based nucleic acid test.

A trained health care professional then conveys test results and provides appropriate counseling to the individual who was tested.

Intercept® Drug Testing System

A collection device that is substantially similar to the OraSure® collection device is sold under the name Intercept®, and is used to collect
oral mucosal transudate for oral fluid drug testing. We have received FDA 510(k) clearance to use the Intercept® collection device with
laboratory-based EIAs to test for drugs-of-abuse commonly identified by the National Institute for Drug Abuse (“NIDA”) as the NIDA-5
(i.e., tetrahydrocannabinol (“THC” or marijuana), cocaine, opiates, amphetamines/methamphetamines and phencyclidine (“PCP”)), and
for barbiturates, methadone and benzodiazepines. Each of these EIAs is also FDA 510(k) cleared for use with the Intercept® device. Our
Intercept® device and oral fluid assays are sold in the U.S. primarily through laboratory distributors.

We believe that the Intercept® device has several advantages over competing urine and other drugs-of-abuse testing products, including
its lower total testing cost, its non-invasive nature, mobility and accuracy, the ease of maintaining a chain-of-custody, the treatment of
test subjects with greater dignity, no requirement for specially-prepared collection facilities and difficulty of sample adulteration. The
availability of an oral fluid test is intended to allow our customers to test for drug impairment and eliminate scheduling costs and
inconvenience, thereby streamlining the testing process.

We have also developed a next-generation collection device, which we are marketing under the trade name “Intercept i2® he”. This
device offers several important advantages over our original Intercept® device, including a sample adequacy indicator that provides a
visual prompt when the appropriate volume of oral fluid has been collected, the ability to collect a larger sample required by current
laboratory testing protocols and a more optimized chemistry that results in improved recovery of the targeted drug analytes. The Intercept
i2®he device is currently being sold as a forensic use only device within the criminal justice and drug treatment markets along with a
NIDA-5 panel of fully-automated high-throughput oral fluid drug assays that we distribute under an agreement with Thermo Fisher
Scientific.

Immunoassay Tests and Reagents

We develop and sell immunoassay tests in formats, known as MICRO-PLATE and AUTO-LYTE®, to meet the specific needs of our
customers. We also sell fully-automated high-throughput oral fluid drug assays developed under our agreement with Thermo Fisher.

Our MICRO-PLATE tests can be performed on commonly used instruments and can detect drugs in urine, serum and sweat specimens.
MICRO-PLATE tests are also used as part of the Intercept® product line to detect drugs-of-abuse in oral fluid specimens and we are
selling a NIDA-5 panel of microplate assays supplied by Thermo Fisher to the U.S. forensic market under the agreement described
above. AUTO-LYTE® tests are sold in the form of bottles of liquid reagents, are run on commercially available laboratory-based
automated analytical instruments, and are typically used in high volume, automated, commercial reference insurance laboratories to
detect certain drugs or chemicals in urine.

Q.E.D.® Saliva Alcohol Test

Our Q.E.D.® saliva alcohol test is a point-of-care test device that is a cost-effective alternative to breath or blood alcohol testing. The
test is a quantitative, saliva-based method for the detection of ethanol, has been cleared for sale by the FDA and has received a CLIA
waiver. The U.S. Department of Transportation (“DOT”) has also approved the test.

Each Q.E.D.® test kit contains a collection stick that is used to collect a sample of saliva and a disposable detection device that displays
results in a format similar to a thermometer. The Q.E.D.® device is easy to operate and instrumentation is not required to read the result.
The product has a testing range of 0 to 0.145% blood alcohol and produces results in approximately two minutes.

Molecular Solutions Products

Genomic Products

We sell many genomic products that provide all-in-one systems for the collection, stabilization, transportation, and storage of DNA,
RNA, as well as both DNA and RNA together from human and animal biological samples. Our lead products are sold under the Oragene®
and ORAcollect® brands and are used to collect genetic material from human saliva. These products are currently sold to thousands of
academic research and commercial customers in many countries worldwide. In 2022, we received FDA clearance for our
ORAcollect®•Dx saliva collection device for OTC use through our partnership with Grifols, which allows our commercial partners to
use and legally market the device with their assays when used in conjunction with their intended uses.

Our genomic products are available in several configurations and contain proprietary chemical solutions optimized for the specific
application for which each product is designed. Product physical design is focused on ease-of-use and reliability for self or assisted
collection of samples. For example, several of the Oragene® products require users to hold the product close to their mouth and spit into
the collection device. When the container is closed, the reagents stored in the container’s lid are mixed with the captured saliva and
stabilize and preserve the nucleic acids in the sample. This non-invasive collection method yields nucleic acid that remains stable at
ambient temperature for extended periods. The stabilizing technology ensures the preservation of high quality and high quantity nucleic
acids required for many genetic testing and analysis methods.

We believe these products provide significant advantages over competing DNA and RNA collection methods such as blood collection
or buccal swabs, particularly in human genetic applications.

Benefits include:

•

Reliable high-quality and stable genetic samples.

Simple, non-invasive collection methods.

The ability to store and transport collected samples for extended periods at ambient temperatures.

Compatibility with fully automated laboratory testing systems.

We also sell the Colli-Pee® collection device for the volumetric collection of first void urine samples. This product is used in liquid
biopsy applications for the prostate and bladder cancer markets and in the sexually transmitted infection screening market.

COVID Collection Products

Since 2020, we have actively engaged with several laboratories and researchers to demonstrate the effectiveness of our existing
collection products for use with COVID-19 molecular testing. We believe that oral samples collected using devices from our product
lines for liquid saliva or oral swab samples are a suitable alternative to more commonly used samples collected with a nasopharyngeal
or oropharyngeal swab. As a result, since 2020, we have sold our ORAcollect® • RNA and OMNIgene® • ORAL collection devices for
use in connection with COVID-19 molecular testing. Due in part to the reduction in the number of COVID-19 cases and the shift toward

the use of antigen testing, the demand for COVID-19 PCR testing declined in 2022, which negatively impacted the sales of our collection
products.

Microbiome Products

We also market several microbiome collection products designed to collect, stabilize, and transport the microbial profile from multiple
sample types. When unstabilized, a microbiome sample can change when exposed to environmental fluctuations, such as temperature
changes. Our microbiome collection products support collecting and stabilizing metabolites found in fecal samples by capturing and
preserving the microbiome after collection until the desired analysis can be performed.

Our OMNIgene® • GUT product is an all-in-one system designed to enable an individual to easily self-collect high-quality microbial
DNA from feces or stool samples for gut microbiome profiling for use in the clinical laboratory and research settings. In 2022, our
OMNIgene® • GUT DNA and RNA collection device (OMR-205), became available to gut microbiome researchers, allowing for self-
collection, stabilization, storage and transportation of microbial DNA and RNA at ambient temperature for gut microbiome profiling.
Most current methodologies for gut microbiome profiling have distinct shortcomings due to the introduction of bias, leading to a lack
of reproducibility in the field. We believe our product ensures that the microbial DNA and RNA in the fecal sample are fully stabilized
immediately upon collection and maintains an accurate and reliable bacterial profile for weeks at room temperature. Recently, we have
applied these principles of sample stabilization to other sample types, including oral, skin, and vaginal samples.

We also launched the OMNIgene®•GUT Dx collection device (OMD-200), which was granted De Novo authorization from the FDA
for collection of human fecal samples and the stabilization of DNA from the bacterial community for subsequent assessment of the
microbiome profile by an assay validated for use with OMNIgene®·GUT Dx device.

Laboratory and Data Analytical Services

Our Molecular Solutions business also offers our customers microbiome laboratory testing and analytical services. Our services focus
on accelerating microbiome discovery for customers in the pharmaceutical, agriculture, and research communities. Our goal is to help
customers unleash the translational potential of the microbiome by providing fast and information-rich characterizations of microbial
diversity and function paired with expert analytics. We also offer comprehensive microbiome and metagenomics services to improve
human, animal, and environmental health and, in 2022, we launched our metatranscriptomics sequencing and analysis services for gut
microbiome samples. These services generate a microbial community’s gene expression profile to provide information about the
interactions between an individual and their microbiome, creating a holistic picture of a sample’s microbial functions and expression
levels. Diversigen has extensive experience with highly diverse microbiome sample types and provides complete project life cycle
consulting services, including pre-project consulting, study design, extraction, and sequencing to complete bioinformatics analysis.
Diversigen is at the forefront of setting quality standards for this industry and has obtained the College of American Pathologists (“CAP”)
accreditation at its laboratory facilities.

Products Under Development

Diagnostic Products

Our research and development efforts include programs targeted at expanding and enhancing our diagnostics business. These programs
typically focus on products related to drug adherence and rapid tests for various diseases.

We are working to develop a 2nd generation Ebola test on the OraQuick® testing platform with funds obtained under our contract with
BARDA.

Molecular Solutions

In order to intersect evolving customer needs within the academic and commercial markets, our molecular business product development
pipeline is focused on extending offerings across different sample types and analytes within both the genomics and microbiome areas.
Genomic customers are demonstrating an increasing demand for collection and stabilization of cell-free nucleic acids, exosomes, DNA
and RNA. On the microbiome front, we continue to focus research and development work on collecting and stabilizing microbial DNA,
RNA and metabolites from multiple sample types including gut, skin, vagina and saliva.

The field of microbiome services is fast paced with evolving biological understanding and development of new methodologies. Our
development efforts are focused on remaining at the forefront of laboratory and informatics technologies, as well as providing new and
relevant services to our customers. These include a focus on laboratory and informatics methods to integrate DNA, RNA and metabolites
from microbial communities across different sample types.

Sales and Marketing

We market our products in the United States and internationally. We attempt to reach our major target markets through a combination
of direct sales, strategic arrangements and independent distributors. Our marketing strategy is to create or raise awareness through a full
array of marketing activities, which include trade shows, print advertising, special programs, distributor promotions, telemarketing and
the use of digital and social media in order to stimulate sales in each target market. Our revenues by geographic area are described in
Note 2 of the Notes to the consolidated financial statements included in Item 15 of this Annual Report.

Diagnostics - Professional

Our InteliSwab® COVID-19 Rapid Test Pro and Rx products are primarily sold through distributors to U.S. hospitals, physician offices
and clinics. These products are also marketed directly to customers in the public health market including clinics and laboratories of state,
county and other governmental agencies.

We market the OraQuick ADVANCE® HIV-1/2 antibody test directly to customers in the public health market for HIV testing. This
market consists of a broad range of clinics and laboratories and includes states, counties, and other governmental agencies, family
planning clinics, colleges and universities, correctional facilities and the military. There are also a number of organizations in the public
health market, such as AIDS service organizations and various community-based organizations, that are set up primarily for the purpose
of encouraging and enabling HIV testing. We sell our OraQuick ADVANCE® test to hospitals and physician offices in the U.S. primarily
through distributors. In addition, we distribute our OraQuick® HIV test in certain foreign countries through distributors.

Our OraQuick® HCV test is sold primarily to the same markets where our OraQuick ADVANCE® HIV test is sold, including public
health organizations, hospitals, physicians and retail clinics. We also sell this test in other countries through distributors.

Diagnostics - OTC and Self-Test

We sell our InteliSwab® COVID-19 Rapid Test product in the U.S. retail and consumer markets, including for purchase by US customers
on Walmart and Amazon’s online stores. The OTC InteliSwab® test is also sold directly and through distributors into a broad range of
business-to-business (B2B) markets including employer testing, colleges and universities, local, state and federal governmental agencies
and the US military.

We sell our OraQuick® In-Home HIV test in the U.S. retail or consumer market. The product is also available for purchase on-line
through certain retailers and from our website, www.oraquick.com. The primary target population for our HIV-OTC test comprises
young, sexually active adults, with greater purchase intent found in high-risk sub-groups, such as men who have sex with men, African
Americans and Latino Americans. We also sell our OraQuick® HIV Self-Test in certain international markets.

Our OraQuick® HIV Self-Test is the only oral fluid HIV test prequalified by the WHO. WHO prequalification helps ensure that
diagnostic tests for high burden diseases meet global standards of quality, safety, and efficacy in order to optimize use of health resources
and improve health outcomes. WHO prequalification enables governmental organizations implementing HIV Self-Test pilots and
programs to access international funding to purchase our test.

Substance Abuse Testing

Our substance abuse testing products are marketed to laboratories serving the workplace testing, forensic toxicology, criminal justice
and drug rehabilitation markets in the U.S. and certain international markets.

We have entered into agreements for the distribution of our Intercept® collection device and associated MICRO-PLATE assays for
drugs-of-abuse testing in the workplace testing market in the United States and Canada through several laboratory distributors and
internationally for workplace, criminal justice and forensic toxicology testing through other distributors. We also market the Intercept®
collection device on its own and as a kit in combination with laboratory testing services. To better serve our workplace customers, we
have contracted with commercial laboratories to provide prepackaged Intercept® test kits, with prepaid laboratory testing and specimen
shipping costs included.

The criminal justice market in the United States for our substance abuse testing products consists of a wide variety of entities in the
criminal justice system that require drug screening, such as pre-trial services, parole and probation offices, police forces, drug courts,
prisons, drug treatment programs and community/family service programs. The forensic toxicology market consists of several hundred
laboratories including federal, state and county crime laboratories, medical examiner laboratories and reference laboratories.

We also sell our next generation Intercept i2® he collection device with a NIDA-5 panel of fully-automated high-throughput oral fluid
assays developed with Thermo Fisher for the detection of PCP, THC, opiates, cocaine, methamphetamines and amphetamines. These
products are currently sold into the criminal justice and drug treatment markets.

We distribute our Q.E.D.® saliva alcohol test primarily through various distributors in the United States and internationally. The markets
for alcohol testing are relatively small and fragmented with a broad range of legal and procedural barriers to entry. Markets range from
law enforcement testing to workplace testing of employees in safety sensitive occupations. Typical usage situations include pre-
employment, random, post-accident, reasonable-cause and return-to-duty testing.

Molecular Solutions

Our Molecular Solutions business sells its products directly to its customers, primarily through its own internal sales force in U.S.
domestic markets. However, in many international markets, distributors are used.

Most of our Molecular Solutions revenues are derived from product sales to commercial customers and sales into the academic and
research markets. Our commercial customers provide consumer genetics and clinical diagnostic services and account for a majority of
these revenues. A significant portion of total sales are derived from repeat customers in both markets. Molecular Solutions also has
customers in the livestock, companion animal and pharmaceutical markets.

We have expanded the market focus of our Molecular Solutions business by selling certain existing collection products for use in
infectious disease testing, including COVID-19 tests, and by developing new collection devices for the emerging microbiome market,
which is focused on the study of microbial communities and their effect on human health. Our primary product offering in the
microbiome market, OMNIgene®•GUT, is focused on the human gut microbiome (microbes living in human stool). We are leveraging
our existing sales force and global research connections to engage microbiome customers around the world and establish ourselves as
among the leaders in ease-of-collection, stabilization and transport of microbiome communities in a variety of challenging sample types
such as stool, skin, vaginal and oral.

Our Molecular Solutions products include the Colli-Pee® device, a product developed and sold by our Novosanis subsidiary, for the
volumetric collection of first void urine. This product is in its early stages and initial sales are occurring primarily through distributors
and collaborations for use in the liquid biopsy and sexually transmitted disease markets.

We also offer laboratory and analytical services for both genomics and microbiome customers in order to more fully meet the needs of
its customers. These services are primarily provided to pharmaceutical and biotech companies and research institutions. During 2019,
we substantially expanded our ability to offer microbiome laboratory and bioinformatics services with the acquisition of CoreBiome
and Diversigen. The laboratory operations of CoreBiome and Diversigen were combined during 2020 under the Diversigen brand.

Significant Products and Customers

Several different product lines have contributed significantly to our financial performance, accounting for 10% or more of our total
revenues during the past three years. The table below shows a breakdown of those product lines (dollars in thousands).

InteliSwab®
Genomics
OraQuick® HIV
COVID-19 collection kits

For the years ended December 31,
2021
2020
2022
22,405 $
63,350
42,144
54,167

$ 233,666 $
54,335
38,812
9,659

—
36,878
44,224
50,927

One of our customers accounted for approximately 58% of our net consolidated revenues in 2022. We had no customers that accounted
for more than 10% of our net consolidated revenues for the years ended December 31, 2021 and 2020.

Supply and Manufacturing

We manufacture all of our OraQuick ADVANCE® Rapid HIV test, OraQuick® In-Home HIV test, OraQuick® HCV test, OraQuick®
Ebola test, OraSure®, Intercept® and Intercept i2® he collection devices, AUTO-LYTE® and MICRO-PLATE assays and Q.E.D.® saliva
alcohol test in our Bethlehem, Pennsylvania facilities. We expect to continue to manufacture these products at this location for the
foreseeable future.

We have contracted with a third party in Thailand for the assembly of the OraQuick® Rapid HIV test and the OraQuick® HIV In-Home
Test in order to supply certain international markets. We believe that other firms would be able to assemble these OraQuick® tests on
terms no less favorable than those set forth in the agreement if the Thailand contractor would be unable or unwilling to continue
assembling this product. We have long-term agreements in place for the contract manufacturing in Thailand and one of our suppliers
has been manufacturing for us for the past 20 years.

We can purchase the HIV antigens, the nitrocellulose and certain other critical components, and the HCV and Ebola antigens used in
our OraQuick® product lines only from a limited number of sources. If for any reason these suppliers are unwilling or no longer able to
supply our antigen or nitrocellulose needs, we believe that alternative supplies could be obtained at a competitive cost. However, a
change in any of the antigens, the nitrocellulose or other critical components used in our products would require FDA approval and
some additional development work. This in turn could require significant time to complete, increase our costs and disrupt our ability to
manufacture and sell the affected products.

We manufacture all of the proprietary chemistry and assay cards for our InteliSwab® COVID-19 Rapid Tests in our Bethlehem,
Pennsylvania facilities. We significantly scaled up manufacturing capacity in the United States for our InteliSwab® COVID-19 Rapid
Tests and have achieved manufacturing capacity targets under our 2021 contract with the US DOD, in coordination with HHS. Funding
under the contract has been, and will be, paid to us based on achievement of milestones through March 2024 for the design, acquisition,
installation, qualification and acceptance of the manufacturing equipment. An existing Company location in Bethlehem, PA has been
retrofitted to accommodate increased manufacturing capacity.

Our MICRO-PLATE and AUTO-LYTE® assays require the production of highly specific and sensitive antibodies corresponding to the
antigen of interest. Substantially all our antibody requirements are provided by contract suppliers. We believe that we have adequate
reserves of antibody supplies and that we have access to sufficient raw materials for these products.

The fully-automated high-throughput oral fluid drug assays sold with our new Intercept i2®he collection device are manufactured and
supplied under a long-term agreement with Thermo Fisher. There is no other supply source for these products.

DNAG has three long-term contract manufacturing relationships to supply virtually all of its products, including the Oragene® product
line. Many of the raw materials and components used in these products are also purchased from third parties, some of which are
purchased from a single source supplier. We are actively seeking to qualify other suppliers that can manufacture and supply the raw
materials and components for the DNAG products. All DNAG products in our Molecular Solutions business are produced in Canada.

Our Colli-Pee® device is currently manufactured at our Belgian assembly facility with components supplied by third party vendors.

Our genomic, microbiome and metatranscriptomics laboratory testing and analytical services are provided by our subsidiary, Diversigen.

Human Capital Resources

In order to achieve the goals and expectations of our Company, it is crucial that we continue to attract and retain top talent. To facilitate
talent attraction and retention, we strive to make OraSure a safe and rewarding workplace with opportunities for our employees to grow
and develop in their careers.

As of December 31, 2022, we had 840 full-time employees, which compares to 785 employees as of December 31, 2021. The increase
in employees during 2022 was primarily the result of the need to add manufacturing capacity for our InteliSwab® COVID-19 Rapid
Test. In February 2023, we announced an 11% reduction in our non-production workforce. Our employees are not currently represented
by a U.S. collective bargaining agreement.

We believe our employees are among our most important resources and are critical to our continued success. We focus significant
attention to attracting and retaining talented and experienced individuals to manage and support our operations, and our management
team routinely reviews employee turnover rates at various levels of the organization. Management also reviews employee engagement
and satisfaction surveys to monitor employee morale and receive feedback on a variety of issues.

The health and safety of our workforce is fundamental to the success of our business. We safeguard our people, projects and reputation
by striving for zero employee injuries and illnesses, while operating and delivering our work responsibly and sustainably. We provide
our employees upfront and ongoing safety training to ensure that safety policies and procedures are effectively communicated and
implemented. Personal protective equipment is provided to those employees where needed for the employee to safely perform their job
function.

As part of our compensation philosophy, we believe that we must offer and maintain market competitive compensation and benefits
programs for our employees in order to attract and retain superior talent. In addition to healthy base wages, additional programs include
annual bonus opportunities, a Company matched 401(k) Plan or other savings plan, healthcare and insurance benefits, health savings
and flexible spending accounts, paid time off, family leave, flexible work schedules, and employee assistance programs.

The OraSure family of companies is committed to creating and fostering a diverse, equitable, and inclusive workplace that reflects and
contributes to the global communities in which we do business and the customers and partners we serve. This includes all communities
impacted by our corporate presence. Our management teams and all of our employees are expected to exhibit and promote honest,
ethical and respectful conduct in the workplace. All of our employees must adhere to a Code of Conduct that sets standards for
appropriate behavior and includes required annual training on preventing, identifying, reporting and stopping any type of unlawful
discrimination. We strive to recruit the best people for the job regardless of gender, ethnicity or other protected trait and it is our policy
to fully comply with all laws (domestic and foreign) applicable to discrimination in the workplace. We have an active Diversity, Equity
and Inclusion Council that strives to drive diversity, equity and inclusion within the workplace. At OraSure, we believe a variety of
perspectives are critical to achieving success, and that diversity, equity and inclusion are key drivers to growth-based innovation and
profitability. We aim to create a culture where all people feel valued, supported, and inspired to be themselves fearlessly, without
judgment. We believe that when all voices are heard, we honor and exemplify our core values and best serve our communities.

2022 Developments

On March 31, 2022, the termination of Dr. Tang as President and Chief Executive Officer (the "CEO") of the Company became effective.
Dr. Nancy Gagliano served as interim CEO for a period commencing on April 1, 2022 and ending on June 4, 2022, at which time Carrie
Eglinton Manner was appointed as President and CEO.

On June 9, 2022, we announced the termination of Agnieszka Gallagher's employment with the Company as Executive Vice President,
General Counsel and Chief Compliance Officer.

On August 8, 2022 our Board of Directors appointed Ken McGrath as the Company’s Chief Financial Officer. Mr. McGrath replaced
Interim Chief Financial Officer, Scott Gleason.

On November 7, 2022 our Board of Directors promoted Kathleen Weber from President, Molecular Solutions to Chief Product Officer.

Competition

Diagnostics

The diagnostic industry is a multi-billion dollar international industry and is intensely competitive. Many of our competitors are
substantially larger than we are, and have greater financial, research, manufacturing and marketing resources than we do. We have
many rapid tests with proprietary features enabling them to compete effectively in select market segments. Broadly, we differentiate
based on our tests’ ease of use, which has enabled us to expand our self-testing offering.

The primary competitive factors for our products include price, quality, performance, ease of use, customer service and reputation.
Industry competition is based on these and the following additional factors:

•

Scientific and technological capability;

Proprietary know-how;

The ability to develop and market products and processes;

The ability to obtain FDA or other regulatory approvals;

The ability to manufacture products that meet applicable FDA or other applicable regulatory requirements;

Commercial execution and strength of distribution;

Access to adequate capital;

The ability to attract and retain qualified personnel; and

The availability of patent protection.

A few large corporations produce a wide variety of diagnostic tests and other medical devices and equipment. A larger number of mid-
size companies generally compete only in the diagnostic industry and a significant number of small companies produce only a few
diagnostic products. As a result, the diagnostic test industry is highly fragmented and segmented. This enables us to serve specific
segments where the products provide a unique benefit.

The future market for diagnostic products is expected to be characterized by greater cost consciousness, the development of new
technologies, tighter reimbursement policies and consolidation. The purchasers of diagnostic products are expected to place increased
emphasis on lowering costs, reducing inventory levels, obtaining better performing products, automation, service and volume discounts.

We expect competition to intensify as technological advances are made and become more widely known, and as new products reach the
market. Furthermore, new testing methodologies could be developed in the future that render our products impractical, uneconomical
or obsolete. There can be no assurance that our competitors will not succeed in developing or marketing technologies and products that
are more effective than those we develop or that would render our technologies and products obsolete or otherwise commercially
unattractive. In addition, there can be no assurance that our competitors will not succeed in obtaining regulatory approval for these
products, or introduce or commercialize them, before we can do so. These developments could have a material adverse effect on our
business, financial condition and results of operations.

Competition in the U.S. market for infectious disease testing in medical settings is intense and is expected to increase. Our principal
competition for HIV testing in the professional market comes from existing and new professional point-of-care rapid blood tests and
automated laboratory-based blood tests. Our OraQuick ADVANCE® rapid HIV test is the only OTC oral fluid test for HIV in the United
States, and as such, enables outreach testing outside of clinics. Our OraQuick® rapid HCV test competes against laboratory-based blood
tests in the U.S., as there currently are no other rapid HCV testing products approved by the FDA.

Our OraQuick® In-Home HIV oral fluid test is the only rapid HIV test approved by the FDA for sale in the US OTC market.

Outside the U.S., our rapid HIV and HCV tests compete against other rapid and laboratory-based tests, which require blood as a sample.
The majority of these blood-based tests are priced at or below our HIV and HCV rapid oral fluid tests. There are no other oral fluid
tests for HCV outside the US with WHO Prequalification status and the CE mark. The majority of our sales outside the US are in Africa
due to the greater incidence of HIV in that region. Our OraQuick® HIV Self-Test is CE marked, which enables us to participate in the
European OTC market for HIV.

The United States COVID-19 rapid testing market consists of tests used by medical professionals at the point-of-care as well as OTC
tests purchased and used by consumers. There are numerous professional point-of-care tests, OTC Antigen rapid tests and OTC rapid
molecular tests authorized under EUA by the FDA. Our InteliSwab® test competes in both the professional point-of-care and OTC
segments with these products.

In the substance abuse testing market, our Intercept® drug testing system competes with laboratory-based drug testing products using
sample matrices such as urine, hair, sweat and oral fluid. We expect competition for our products to intensify, particularly from other
domestic and international companies that have developed, or may develop, competing oral fluid drug testing products.

Our MICRO-PLATE oral fluid drug assays, which are sold for use with the original Intercept® collector and our OraSure® collection
device, also continue to come under increasing competitive pressure from “home-brew” assays developed internally by our laboratory
customers. Our oral fluid MICRO-PLATE assays also compete with urine-based homogeneous assays that are run on fully-automated,
random access analyzers.

Our MICRO-PLATE drugs-of-abuse reagents sold in the forensic toxicology market are targeted to forensic testing laboratories where
sensitivity, automation and “system solutions” are important. We compete with both homogeneous and heterogeneous tests
manufactured by many companies.

Q.E.D.® competes against other semi-quantitative saliva-based alcohol tests that have received U.S. Department of Transportation
approval as well as breath alcohol tests. Although there are lower priced tests on the market that use oral fluid or breath as a test medium,
we believe that these tests are qualitative tests that we believe are lower in quality and provide fewer benefits than our Q.E.D.® test.

Molecular Solutions

Our Oragene® and ORAcollect® collection systems compete against other types of collection devices used for molecular testing, such
as blood collection devices and buccal swabs, which often are sold for prices lower than the prices charged for the Oragene® and
ORAcollect® products. Although we believe the Oragene® and ORAcollect® devices offer a number of advantages over these other
products, the availability of lower price competitive devices can result in lost sales and degradation in pricing and profit margin. Our

Oragene® and ORAcollect® products are also facing increasing competition from similarly designed collection systems which are
beginning to enter the market. With the receipt of authorizations for use in connection with COVID-19 molecular tests, our Oragene®
and ORAcollect® products now compete against COVID-19 testing systems and the collection methods used in those systems.

OMNIgene®• GUT is being sold in the emerging microbiome market and competes with a variety of non-standard in-house solutions
developed by various researchers, including simply freezing the sample after collection. The microbiome market is expected to require
standardization in the methods used for collection and stabilization in order to derive more accurate and repeatable results. To date, we
are one of the few vendors to offer a solution that fully meets these requirements.

Our genomic, microbiome and metatranscriptomics laboratory service offerings primarily compete against a number of commercial
reference laboratories, specialty laboratories and hospital laboratories in the U.S.

Patents and Proprietary Information

We seek patents and other intellectual property rights to protect and preserve our proprietary technology and our right to capitalize on
the results of our research and development activities. We also rely on trade secrets, know-how, continuing technological innovations
and licensing opportunities to provide competitive advantages for our products in our markets and to accelerate new product
introductions. We regularly search for third-party patents in fields related to our business to shape our own patent and product
commercialization strategies as effectively as possible and to identify licensing opportunities. United States patents generally have a
maximum term of 20 years from the date an application is filed.

We have patents throughout our product and service lines. Our patent portfolio includes pending applications and issued patents in
diagnostics and testing, sampling tools, and services and analysis. Our portfolio protects our innovative sampling tools, services and
diagnostics that provide access to accurate, essential information that advances global health and well-being.

Diagnostics and testing products include the OraSure® and Intercept® collection devices that are covered by one utility and one design
patent in each of the U.S., Canada, Japan, and throughout Europe. We have numerous foreign patents for its collection devices and
technology relating to oral fluid collection, containers for oral fluids, methods to test oral fluids, and methods to control the volume of
oral fluids collected and dispersed. The utility patents will expire in January 2028, and the design patents will expire in 2025.

Sampling tools are the subject of several other patents and pending applications, including U.S. and international utility patent
applications directed to a new oral fluid collection device. The international applications will enter their national phase in countries
throughout the world beginning in October 2023. Patents issuing from these applications will expire in March 2041.

We have a U.S. and international PCT patent applications that are directed to a new developer solution vial for use with sampling and
assay devices. The international application and will enter its national phase in countries throughout the world, beginning in May 2023
and patents issuing from these applications will expire in December 2041. Related design patent applications are pending in the U.S.,
Canada, and Europe.

We have additional pending applications directed to new direct sample collection pads for our InteliSwab® COVID-19 Rapid Test.
These applications will enter their national phase in countries throughout the world, beginning in October 2023, and patents issuing
from these applications will expire in December 2042. A related design patent issued in 2022 in the U.S. and corresponding design
applications were registered in Canada, China, India, and Europe. These design patents will expire 2035.

We have registered design patents for a collection funnel and corresponding plunger device in Europe, China, and India and a
corresponding U.S. design patent application is pending.

We have pending patent applications throughout our product and service lines directed to assays, methods, devices, and reagents for
monitoring adherence to HIV medications, such as nucleoside reverse transcriptase inhibitors used in PrEP regimens.

We have two international families of patent applications filed in the United States and in numerous countries worldwide. These
applications are directed to novel nucleoside reverse transcriptase inhibitor-specific antibodies for use in assays to detect the presence
of nucleoside reverse transcriptase inhibitor drug derivatives, including tenofovir, in fluid samples. Patents issuing from these
applications will expire in October 2038 and December 2040.

We hold, through our subsidiary, DNAG, thirty granted United States patents and numerous foreign patents issued for compositions,
methods and apparatuses for the collection, stabilization, transportation, and storage of nucleic acids (DNA and RNA) from oral fluid
and other bodily fluids and tissues. These patents expire from June 2023 through October 2037.

We hold through our subsidiary, Novosanis, one granted United States patent and numerous foreign patents covering a medical device
for capturing a predetermined volume of first void urine. This patent expires in September 2033. We have also applied for additional
patents, in both the United States and certain foreign countries, in novel urine collection devices.

Our subsidiary, Diversigen, has licensed one United States patent and several foreign patent applications from the University of
Minnesota for analytical standards to detect and/or measure sampling, processing, and/or amplification errors in a biological sample
containing polynucleotide molecules. These patents will expire in May 2036. This license also covers certain software and know-how
related to laboratory and bioinformatics procedures and processes. Diversigen has also licensed certain know-how and database assets
from the Baylor College of Medicine related to laboratory processes for microbiome and metagenomics services.

We require our employees, consultants, outside collaborators and other advisors to execute confidentiality agreements upon the
commencement of employment or consulting relationships with us. These agreements provide that all confidential information
developed by or made known to the individual during the course of the individual’s relationship with us is to be kept confidential and
not disclosed to third parties except in specific circumstances. In the case of employees and certain consultants, the agreements also
provide that all inventions conceived by the individual during his or her tenure with us or the performance by the consultant of services
for us will be our exclusive property.

We own rights to trademarks and service marks that we believe are necessary to conduct our business as currently operated. In the
United States, we own a number of trademarks, including the OraSure®, Intercept®, Intercept i2®he, OraQuick®, OraQuick ADVANCE®,
OraSure QuickFlu®, Q.E.D.®, InteliSwab®, Oragene®, DNA Genotek®, OMNImetTM, ORAcollect®, OMNIgene®, goDNATM,
Diversigen®, CoreBiome®, Boostershot®, MetaGeneTM, BenchmarkTM, Novosanis®, Colli-Pee®, UCM®, UASTM, AUTO-LYTE®,
prepIT®, and Hemagene® trademarks. We also own many of these marks and others in several foreign countries and we are pursuing
registration of several other trademarks.

Although important, the issuance of a patent or existence of trademark or trade secret protection does not in itself ensure the success of
our business. Competitors may be able to produce products competing with our patented products without infringing our patent rights.
Issuance of a patent in one country generally does not prevent manufacture or sale of the patented product in other countries. The
issuance of a patent is not conclusive as to validity or as to the enforceable scope of the patent. The validity or enforceability of a patent
or trademark can be challenged by litigation after its issuance or registration. If the outcome of such litigation is adverse to the owner of
the patent, the owner’s rights could be diminished or withdrawn. Trade secret protection does not prevent independent discovery and
exploitation of the secret product or technique.

Government Regulation

General

Most of our products are regulated by the FDA, along with other federal, state and local agencies and comparable regulatory bodies in
other countries. This regulated environment governs almost all aspects of development, production and marketing, including product
design and testing, authorizations to market, labeling, advertising and promotion, manufacturing, distribution, post-market surveillance
and reporting, and recordkeeping. We believe that our products and procedures are in material compliance with all applicable regulations,
but the regulations regarding the manufacture and sale of our products may be unclear and are subject to change. We cannot predict the
effect, if any, that these changes might have on our business, financial condition or results of operations.

Many of our FDA-regulated products require some form of review and action by the FDA before they can be marketed in the United
States. After approval or clearance by the FDA, we must continue to comply with other FDA requirements applicable to marketed
products and are subject to periodic inspections by the FDA and other regulatory bodies. Both before and after approval or clearance,
failure to comply with the FDA’s requirements can lead to significant penalties or could disrupt our ability to manufacture and sell these
products. In addition, the FDA could refuse permission to obtain certificates needed to export our products if the agency determines that
we are not in compliance.

Domestic Regulation

Most of our products are regulated in the United States as in vitro diagnostic and medical devices. In the United States, devices are
classified into three groups based on risk: class I (lowest risk), class II (moderate risk), and class III (highest risk). The classification of
a device determines the level of regulation applicable to the device: class I devices are subject only to the general controls that are
applicable to all regulated devices; class II devices are subject to both general controls and special controls, which are specific to the
type of device; and class III devices are subject to general controls and any other controls that are needed to provide reasonable assurance
of the safety and effectiveness of the specific device.

The classification of the device also influences the type of premarket submission that is required before the device can be marketed.
Some low risk devices (including many class I and some class II devices) may be placed on the market without any premarket
submission. Such devices often are referred to as “exempt” or “510(k)-exempt.” Most devices, however, require some form of premarket
submission prior to marketing. There are several mechanisms by which such devices can be placed on the market in the United States,
including 510(k)-clearance, de novo classification, premarket approval, or EUA.

Many class II devices and some class I devices may qualify for clearance under Section 510(k) of the Federal Food, Drug and Cosmetic
Act (the "FDCA"). To obtain this clearance from the FDA, the manufacturer must submit to the FDA a premarket notification that it
intends to begin marketing the product, and show that the product is substantially equivalent to another legally marketed predicate device
(i.e., a device that has been cleared through the 510(k) process; a device that was legally marketed prior to May 28, 1976; a device that
has been reclassified by the FDA; or a device that the FDA previously has determined to be exempt from the 510(k) process). To be
substantially equivalent, an applicant must show that when compared to a predicate, the new device has the same intended use and same
technology, or if different technology, that the new device is as safe and effective as the predicate and does not raise different questions
of safety and effectiveness. In all cases, data from some form of performance testing is required and in some cases, the submission must
include data from human clinical studies. An applicant must submit a 510(k) notification at least 90 days before commercial distribution
of the product commences. Marketing may only commence when the FDA issues a clearance letter finding that the new device is
substantially equivalent to the predicate device. The standards and data requirements necessary for the clearance of a new device may
be unclear or may be subject to change. Although FDA clearance usually takes from four to twelve months, in some cases more than a
year may be required before clearance is obtained, if at all.

If the device does not qualify for the 510(k) procedure, either because there is no existing predicate device, it is not substantially
equivalent to a legally marketed predicate device or because it is classified by the FDA as a class III device, the FDA must approve
either a PMA application or for devices that are low to moderate risk, grant a request for de novo classification before marketing can
begin. A de novo classification is an alternate pathway to classify novel devices of low to moderate risk for which no substantially
equivalent predicate device exists into class I or class II. The FDA’s goal is to decide a de novo request in 150 days from the time the
request is received, although it can take longer.

PMAs generally are required for class III devices, i.e., high risk devices, and must demonstrate, among other matters, that the medical
device provides a reasonable assurance of safety and effectiveness for the intended use(s) of the device. A PMA is typically a complex
submission, supported by valid scientific evidence, including the results of preclinical and clinical studies, usability data, detailed
information about the manufacturing process for the device, and other data and information. Preparing a PMA is a resource-intensive
and time-consuming process. Once a PMA has been submitted, the FDA is required to review the submission within 180 days. However,
the FDA’s review may be, and often is, much longer, in many cases requiring one to three years or more, and may include requests for
additional data, review by an independent panel of experts, and facility inspections before approval is granted, if at all.

If the FDA approves the PMA, it may place restrictions on the device. If the FDA’s evaluation of the PMA or the manufacturing facility
is not favorable, the FDA may deny approval of the PMA application or issue a “not approvable” letter. The FDA may also require
additional clinical trials, which can delay the PMA approval process by several years or prevent a PMA approval from being obtained.

If the FDA discovers that an applicant has submitted false or misleading information in any application or notification, the FDA may
take action against the applicant and its employees or refuse to review submissions until certain requirements are met pursuant to its
Application Integrity Policy. Delays in receipt of or failure to receive such clearances or approvals, the loss of previously received
clearances or approvals, or the failure to comply with existing or future regulatory requirements could have a material adverse effect on
our business, financial condition and results of operations.

Another option for marketing a product in the U.S. is through an EUA. FDA may grant an EUA for a product if the Secretary of Health
and Human Services declares that circumstances exist justifying the authorization of emergency use of certain products. Such
declaration may be made following a determination by the Secretary of Health and Human Services that there is a public health
emergency, by the Secretary of Homeland Security that there is a domestic emergency, or by the Secretary of Defense that there is a
military emergency, or the declaration may be made if a material threat is identified under a particular provision of the Public Health
Service Act. Typically, a diagnostic device may receive EUA-authorization on the basis of analytical and clinical studies that do not
satisfy the requirements for full clearance or approval. Devices also may be exempt from design controls and other quality requirements.
An EUA for a device remains in effect until the Secretary of Health and Human Services, in consultation with the Secretary of Defense,
determines that the circumstances justifying emergency use of the device no longer exist, or until the authorized device is approved or
cleared.

If there are any modifications made to our marketed devices, a new premarket notification, PMA supplement, or request to change an
EUA may be required to be submitted to, and cleared, approved, or authorized by, the FDA, before the modified device may be marketed.

A new PMA or a PMA supplement is required for modifications that affect the safety or effectiveness of the device, including, for
example, certain types of modifications to the device’s intended use(s), manufacturing process, manufacturing facility, critical
components, labeling and design. Likewise, a new 510(k) clearance is required for any modification that could significantly affect the
safety or effectiveness of the device, e.g. a significant change or modification in design, material, chemical composition, energy source,
or manufacturing process or a major change or modification in the intended use(s) of the device.

A clinical trial may be required in support of a 510(k) submission and generally is required for a de novo request or PMA application.
These trials generally require an approved application for an Investigational Device Exemption (“IDE”) and compliance with other IDE
requirements, unless the proposed study is deemed to be exempt from the IDE requirements. An IDE application must be supported by
appropriate data, such as laboratory testing results, protocols for the proposed investigation, and other information demonstrating that
the device is appropriate for use with humans in a clinical study. Clinical trials may begin if the IDE application is approved by the FDA
and the appropriate institutional review boards at the clinical trial sites. Submission of an IDE application does not give assurance that
the FDA will issue the IDE. If the IDE application is approved, there can be no assurance the FDA will determine that the data derived
from the trial(s) support the ultimate approval or clearance of the device or warrant the continuation of clinical trials. An IDE supplement
must be submitted to and approved by the FDA before a sponsor or investigator may make a change to the investigational plan in such
a way that may affect its scientific soundness, study indication or the rights, safety or welfare of human subjects. The trial must also
comply with the FDA’s regulations, including the requirement that informed consent be obtained from each subject, and with clinical
trial reporting regulations that require submission of information on certain clinical trials to a database maintained by the National
Institutes of Health. Even if a trial is completed, the results of clinical testing may not adequately demonstrate the safety and efficacy of
the device or may otherwise not be sufficient to obtain FDA clearance to market the product in the United States. If a study meets the
requirements for a non-significant risk study, however, it may be eligible for compliance with “abbreviated” IDE requirements, which
include a subset of the requirements applicable to significant risk medical device studies. A non-significant risk study also will be
considered to have an approved IDE application without such application actually being submitted to FDA.

Some of our products are used for research only or for other nonclinical or non-diagnostic purposes. Our molecular collection products
are sold to many academic and research institutions for research purposes and our drugs-of-abuse products are sold to laboratories and
clinics for forensic or other non-medical uses. The FDA does not currently regulate products used for these purposes, although other
state and federal regulatory requirements may apply.

Most devices distributed in the United States must comply with the FDA’s Quality System Regulations (“QSRs”), including current
good manufacturing practices. These regulations govern the entire life cycle of a medical device, including design, manufacture, testing,
release, packaging, distribution, documentation and purchasing as well as complaint handling, corrective and preventative actions, and
internal auditing. In complying with the QSRs, manufacturers must continue to expend time, money and effort in the area of production,
quality, and post-market surveillance to ensure full compliance.

Companies that market devices are also subject to other post-market and general requirements, including product listing and
establishment regulations, which help facilitate FDA inspections and other regulatory action, post-market surveillance requests,
restrictions imposed on marketed products, promotional standards and requirements for recordkeeping and reporting of certain adverse
reactions and device malfunctions. Device reporting regulations require that manufacturers report if their device may have caused or
contributed to a death or serious injury, or has malfunctioned in a way that would likely cause or contribute to a death or serious injury
if the malfunction of the device or a similar device were to recur.

The FDA regularly inspects companies to determine compliance with the QSRs and other post-market requirements. Failure to comply
with statutory requirements and the FDA’s regulations can result in an FDA Form 483 (which is issued by the FDA at the conclusion of
an inspection when an investigator has observed any conditions that may constitute violations), public warning letters, monetary
penalties against a company or its officers and employees, suspension or withdrawal of regulatory approvals, operating restrictions, total
or partial suspension of production, injunctions, product recalls, product detentions, refusal to provide export certificates, seizure of
products and criminal prosecution. We believe that our facilities and procedures are in material compliance with the FDA’s OSR
regulations and other post-market requirements, but the regulations are subject to change or may be unclear, and we cannot be sure that
FDA investigators will agree with our compliance with the FDA’s post-market requirements.

CLIA prohibits any facility that conducts laboratory testing on specimens derived from humans from providing information for the
diagnosis, prevention or treatment of any disease or impairment of, or the assessment of, the health of human beings, unless there is in
effect for such facility a certificate issued by the U.S. Department of Health and Human Services or an accredited organization, and such
certificate is applicable to the category of examination or procedure performed. Tests may be categorized as “waived,” enabling them
to be used by laboratories with the lowest level of CLIA oversight if the tests meet certain requirements established under CLIA. We
consider the applicability of CLIA requirements in the design and development of our products. We have obtained a waiver of the CLIA
requirements for our OraQuick ADVANCE® rapid HIV-1/2 antibody test, our OraQuick® HCV rapid antibody test and our Q.E.D.®
alcohol saliva test and may seek similar waivers for certain other products. In addition, the supplier of the OraSure Quick-Flu® test has

obtained a CLIA waiver for that product. The InteliSwab® COVID-19 Rapid Test Pro is authorized for use in patient care settings
operating under CLIA Certificate, Certificate of Compliance and Certificate of Accreditation.

The laboratory services provided by our subsidiary, Diversigen, consist of microbiome, metatranscriptomics and metagenomics
sequencing, bioinformatics and analysis. Diversigen has elected to obtain a license from CLIA and has received a certificate of
accreditation from the College of American Pathologists (CAP).

Certain of our products may also be affected by state regulations in the United States, which can restrict the use and sale of certain
diagnostic products.

Advertising and Promotion

Advertising and promotion of medical devices, in addition to being regulated by the FDA, are also regulated by the Federal Trade
Commission and by other federal and state regulatory and enforcement authorities, including the Department of Justice, the Office of
Inspector General of the Department of Health and Human Services, and various state attorneys general. Although physicians are
permitted to exercise medical judgment to use medical devices for indications other than those cleared or approved by the FDA, we may
not promote our products for such “off-label” uses and can only market our products for cleared or approved uses. Promotional activities
for FDA-regulated products of other companies have also been the subject of enforcement actions brought under healthcare
reimbursement laws and consumer protection statutes. In addition, under the federal Lanham Act and similar state laws, competitors
and others can initiate litigation relating to advertising claims. If the FDA determines that our promotional materials or training constitute
promotion of an uncleared or unapproved use, it could request that we modify our training or promotional materials or subject us to
regulatory or enforcement actions, including the issuance of an untitled letter, a notice of violation, a warning letter, injunction, seizure,
civil fine or criminal penalties. Federal Trade Commission enforcement actions often result in consent decrees that constrain future
actions. Department of Justice prosecutions can result in significant criminal and civil penalties, including exclusion from the Medicare
and Medicaid programs. If an enforcement action is brought by the FDA or Federal Trade Commission, our reputation could be damaged
and sales of our products could be impaired.

Import and Export Requirements

Products for export from the United States are subject to foreign countries’ import requirements and the exporting requirements of the
FDA, as applicable. In particular, international sales of medical devices manufactured in the United States that are not approved or
cleared by the FDA for use in the United States, or are banned or deviate from lawful performance standards, are subject to FDA export
requirements.

Foreign countries often require, among other things, an FDA certificate for products for export, also called a Certificate for Foreign
Government (“CFG”). To obtain this certificate from the FDA, the device manufacturer must apply to the FDA. The FDA certifies that
the product has been granted clearance or approval in the United States and that the manufacturing facilities were in compliance with
QSR regulations at the time of the last FDA inspection. If the FDA determines that our facilities or procedures do not comply with the
QSR regulations, it may refuse to provide such certificates until we resolve the issues to the FDA’s satisfaction. Failure to obtain a CFG
could inhibit our ability to export our products to countries that require such certificates.

International

We are also subject to regulations in foreign countries governing products, human clinical trials and marketing, and may need to obtain
approval (or pre-qualification or endorsement) from local regulators in such countries or international public health agencies, such as
the World Health Organization, in order to sell products in certain countries. Approval processes vary from country to country, and the
length of time required for approval or to obtain other clearances may in some cases be longer than that required for U.S. governmental
approvals. We generally pursue approval only in those countries that we believe have a significant market opportunity.

The International Organization for Standardization (“ISO”) is a worldwide federation of national standards bodies. ISO 13485
certification indicates that our quality system complies with standards applicable to activities ranging from initial product design and
development through production and distribution.

The European Union (“EU”) adopted the EU Medical Devices Regulation (the “EU MDR”) and the In Vitro Diagnostic Medical Devices
Regulation (the “EU IVDR”), which repealed and replaced the Medical Devices Directive (“MDD”) and the In Vitro Diagnostic Medical
Devices Directive (“IVDD”), respectively. The EU MDR and EU IVDR impose stricter pre-market and post-market requirements for
the marketing and sale of medical devices and in vitro diagnostic medical devices, including in the area of clinical evaluation
requirements, quality systems and post-market surveillance. The EU IVDR became applicable on May 26, 2022. There is a transitional
period during which products that have a declaration of conformity issued under the IVDD prior to May 26, 2022 may continue to be

placed on the EU market for a certain period before requiring certification under the IVDR; however, class A non-sterile products do
not benefit from such transitional provisions and have been required to be IVDR compliant since May 26, 2022.

In the EU, products that fall under the scope of the MDR and the IVDR are not subject to the prior approval of a regulatory authority,
but, depending on the class of product, may require prior review by a notified body. Notified bodies are accredited and supervised by
national regulatory authorities to conduct conformity assessment procedures of medical devices or other products. Such products must
comply with certain essential requirements listed in those directives. ISO certification creates a rebuttable presumption that the product
satisfies the applicable requirements. Compliance with these requirements allows us to complete the applicable conformity assessment
procedure, involving a notified body where necessary, and to affix the CE mark to our products, without which they may not be placed
on the market in the EU. We also note that from January 1, 2021, the United Kingdom (“UK”) has introduced a UK-specific route to
market for medical devices. Compliance with these requirements may add further complexities to our international strategy.

We must also comply with certain registration and licensing requirements as dictated by Health Canada, prior to commencing sales in
Canada. We have completed this process for several of our current products and may do so with respect to other products in the future.
In addition, Canadian law requires manufacturers of medical devices to have a quality management system that meets various ISO
requirements in order to obtain a license to sell their devices in Canada. Health Canada also requires all companies that market Class II,
Class III and Class IV products in Canada to be certified as part of the Medical Device Single Audit Program ("MDSAP"). We received
this certification for our Diagnostics segment (previously named "OSUR") in January 2019 as well as for our Molecular Business Unit
in February 2020.

We have obtained WHO pre-qualification for our OraQuick® HIV-1/Antibody Test, OraQuick® HIV Self-Test and OraQuick® HCV.

Anti-Kickback and Other Fraud and Abuse Laws

The Federal Anti-Kickback Statute prohibits the knowing and willful offer, payment, solicitation, or receipt of any form of remuneration
in return for, or to induce:

•

The referral of an individual to a person for the furnishing or arranging for the furnishing of items or services reimbursable
under Medicare, Medicaid or other governmental healthcare programs; or

The purchase, lease, or order of, or the arrangement or recommendation of the purchasing, leasing, or ordering of any item
or service reimbursable under Medicare, Medicaid, or other governmental healthcare programs.

Our products are or may be purchased by customers that will seek or receive reimbursement under Medicare, Medicaid or other
governmental healthcare programs. Noncompliance with the Federal Anti-Kickback Statute can result in exclusion from Medicare,
Medicaid or other governmental healthcare programs, and/or restrictions on our ability to operate in certain jurisdictions, as well as civil
and criminal penalties, any of which could have an adverse effect on our business and results of operations.

The False Claims Act (“FCA”) imposes liability on any person or entity who, among other things, knowingly and willfully presents, or
causes to be presented, a false or fraudulent claim for payment by a federal health care program, including Medicaid and Medicare. A
violation of the Federal Anti-Kickback Statute is considered a violation of the FCA. Some suits filed under the FCA, known as “qui
tam” actions, can be brought by a “whistleblower” or “relator” on behalf of the government, and such individuals may share in any
amounts paid by the entity to the government in fines or settlement. Manufacturers can be held liable under false claims laws, even if
they do not submit.

The Beneficiary Inducement provisions of the Federal Civil Monetary Penalties Law prohibits the offering or transferring of
remuneration to a Medicare or Medicaid beneficiary that the person knows or should know is likely to influence the beneficiary’s
selection of a particular provider, practitioner or supplier of Medicare or Medicaid payable items or services. Noncompliance can result
in civil monetary penalties for each wrongful act, assessment of three times the amount claimed for each item or service and exclusion
from the Federal healthcare programs.

Many states have also adopted some form of anti-kickback laws and false claims laws. A determination of liability under such laws
could result in fines and penalties, restrictions on our ability to operate in these jurisdictions and significant damage to our reputation.

We are also subject to other federal and state laws targeting fraud and abuse in the healthcare industry, including marketing conduct
laws, transparency laws, and laws that require us to adopt a compliance program. Taken together, these fraud and abuse laws constrain
the sales, marketing and other promotional activities of manufacturers of medical devices by limiting the kinds of financial arrangements,
including sales programs, such manufacturers can enter into with physicians, hospitals, laboratories and other potential purchasers of
medical devices. Violations of these laws may be punishable by criminal or civil sanctions, including substantial fines, imprisonment
and exclusion from participation in government healthcare programs such as Medicare and Medicaid. These laws and regulations are

wide ranging and subject to changing interpretation and application. In recent years, there has been greater scrutiny of marketing
practices in the medical device industry which has resulted in several government investigations by various government authorities and
the introduction and/or passage of federal and state legislation regulating interactions between medical device manufacturers and
healthcare professionals and providers and requiring the disclosure by medical device manufacturers of payments to certain healthcare
providers. For example, under the Physician Payments Sunshine Act provisions of the Affordable Care Act, device manufacturers are
subject to federal reporting and disclosure requirements with regard to payments or other transfers of value made to U.S. physicians,
certain other licensed health care practitioners, and teaching hospitals. Reports submitted under the Sunshine Act are placed in a public
database. Device manufacturers are required to submit annual reports by March 31 which cover the prior calendar year. To be in
compliance with such disclosure laws, we have implemented necessary systems to accurately track gifts and other payments.

We have implemented a written Policy on Interactions with Health Care Professionals, which is based on the Code of Ethics for
Interactions with Health Care Professionals promulgated by the Advanced Medical Technology Association, (the "AdvaMed"), a leading
trade association representing medical device manufacturers. The Policy applies to all employees and is intended to comply with
applicable state and federal laws, regulations and government guidance. The Policy addresses interactions related to sales and marketing
practices, research and development, product training and education, grants and charitable contributions, support of third-party
educational conferences, and consulting arrangements. While we believe that our practices are in compliance with the Anti-Kickback
and other fraud and abuse laws, the standards for compliance with such statutes can be unclear and subject to change.

Foreign Corrupt Practices Act and Other Anti-Corruption Laws

The U.S. Foreign Corrupt Practices Act (“FCPA”), to which we are subject, prohibits corporations and individuals from engaging in
bribery and corruption when dealing with foreign government officials and foreign political parties. It is illegal to corruptly offer, pay,
promise, or authorize the giving of anything of value to any officer or employee of a foreign government or public international
organization, political party, political party official, or political candidate, in an attempt to obtain or retain business or to otherwise
improperly influence a person working in an official capacity on behalf of a foreign government or public international organization.
Our present and future business has and will continue to be subject to the FCPA and various other laws, rules and/or regulations
applicable to us as a result of our international sales. We also are subject to the FCPA’s accounting provisions, which require us to keep
accurate books and records and to maintain a system of internal accounting controls sufficient to assure management’s control, authority,
and responsibility over the company's assets. The failure to comply with the FCPA and similar laws could result in civil or criminal
sanctions or other adverse consequences.

The laws to which we are subject as a result of our international sales also include the U.K. Bribery Act (the “Bribery Act”), which
proscribes giving and receiving bribes in the public and private sectors, bribing a foreign public official, and failing to have adequate
procedures to prevent employees and other agents from giving bribes. U.S. companies that conduct business in the United Kingdom
generally will be subject to the Bribery Act. Penalties under the Bribery Act include potentially unlimited fines for companies and
criminal sanctions for corporate officers under certain circumstances.

Environmental Regulation

Because of the nature of our current and proposed research, development, and manufacturing processes, we are subject to stringent
federal, state and local laws, rules, regulations and policies governing the use, generation, manufacture, storage, air emission, effluent
discharge and handling and disposal of solid wastes, hazardous materials and hazardous wastes. Products that we sell in Europe are
subject to regulation in EU markets under the Directive on the Restriction of the Use of Certain Hazardous Substances (“RoHS”). RoHS
prohibits companies from selling electrical and electronic equipment, such as electronic medical devices, that contain certain hazardous
materials, including lead, mercury, cadmium, chromium, polybrominated biphenyls and polybrominated diphenyl ethers, in the EU
Member States. In addition, the EU’s Regulation on the Registration, Evaluation, Authorization, and Restriction of Chemicals
(“REACH”) imposes severe restrictions and requirements on companies marketing devices in the EU. Among other things, REACH
requires companies to obtain prior authorization to use substances of very high concern that are listed for authorization, and imposes
bans on the marketing of products that contain specifically listed hazardous substances. Companies marketing medical devices in the
EU may also be subject to expensive waste take back obligations under the EU Directive on Waste Electrical and Electronic Directive,
the Packaging and Packaging Waste Directive, and the Batteries Directive.

Future environmental laws, rules, regulations or policies may require us to alter our manufacturing processes, thereby increasing our
manufacturing costs, or may impose other additional obligations on us or our products. We believe that our products and manufacturing
processes at our facilities comply in all material respects with applicable environmental laws and worker health and safety laws;
however, the risk of environmental liabilities cannot be completely eliminated.

The foregoing discussion of our business should be read in conjunction with the consolidated financial statements and accompanying
notes included in Item 15 of this Annual Report.

Information Available on the Internet

Our filings with the Securities and Exchange Commission, including Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q,
Current Reports on Form 8-K, including exhibits, proxy and information statements and amendments to those reports filed or furnished
pursuant to Sections 13(a) and 15(d) of the Exchange Act are available on our website (www.orasure.com) free of charge as soon as
reasonably practicable after we electronically file such material with, or furnish it to, the SEC at its website (https://www.sec.gov). The
information contained on our website is not a part of this Annual Report.

ITEM 1A. Risk Factors

Summary of Risk Factors

Investing in our securities involves risk. Below is a summary of the principal factors that could adversely affect our business, operations
and financial results. You should carefully consider the following risks and uncertainties, together with all other information in this
Annual Report, including our consolidated financial statements and related notes and the "Management's Discussion and Analysis of
Financial Condition and Results of Operations" section, before investing in our Company. This summary does not address all of the
risks that we face. Additional discussion of the summarized risks can be found below following this summary.

Risks Relating to Products, Marketing and Sales

•

Changes in the genomics market may adversely affect our business.

Our future success depends upon market acceptance of our existing and future products and service offerings.

We may not realize anticipated revenue from our InteliSwab® COVID-19 rapid test.

The COVID-19 pandemic continues to cast uncertainty over our consolidated results of operations, financial position and
cash flows, while the consequences of COVID-19 and the governmental response to the pandemic and pandemic-related
macroeconomic impacts could negatively affect our operations and share price;

Marketing of our COVID-19 tests and collection kits under EUAs from the FDA is subject to certain limitations and we are
required to maintain compliance with the terms of the EUA, among other things, and the continuance of the EUAs is subject
to government discretion.

If acceptance and adoption of oral fluid testing and collection products does not continue, our further results may suffer.

We expect to face increasing competition from other providers of diagnostic tests, sample collection products and molecular
laboratory services.

Our inability to expand international sales could adversely affect our business and results of operations.

Our international presence may increase our risks and expose our business to regulatory, cultural or other restraints.

Our U.S. government contracts require compliance with numerous laws and increases our risk and liability.

Our inability to manufacture products in accordance with applicable specifications, performance standards or quality
requirements could adversely affect our business.

Our business will suffer if we do not effectively manage challenges to our manufacturing processes and we may be unable
to successfully scale-up manufacturing of our products in sufficient quality and quantity to meet demand, which would
negatively impact revenue expectations.

Our business results depend on our ability to manage disruptions in our domestic and global supply chains and distribution
channels.

Certain of our products depend on components from a sole-source supplier, the loss of which would cause us to be unable
to deliver such products.

Our U.S. government contracts may affect our intellectual property rights.

We may not be able to fulfill our obligations under government contracts, which could result in reduced sales and profits,
contract penalties or terminations and damages to customer relationships.

Risks Relating to Our Industry, Business and Strategy

•

Consolidation in the healthcare industry could adversely affect our future revenues and operating results.

Our research, development and commercialization efforts may not succeed and our competitors may develop and
commercialize more effective or successful offerings.

Customer concentration creates risk for our business.

Acquisitions or investments may not generate the expected benefits and could disrupt our ongoing business, distract our
management, increase our expenses and adversely affect our business.

There are risks relating to our recent acquisitions.

•

Our revenues could be affected by third-party reimbursement policies and potential cost constraints.

Changes in healthcare regulation could affect our revenues, costs and financial condition.

Reductions in government funding and research budgets could adversely affect our business and financial results.

Risks Relating to Our Reliance on Third Parties

•

The use of third party supply sources for critical components of our products could adversely affect our business.

Our failure to maintain existing distribution channels, or develop new distribution channels, may result in lower revenues.

Risks Relating to Intellectual Property

•

Our success depends on our ability to protect our proprietary technology.

We may become involved in intellectual property disputes, which could increase our costs and limit or eliminate our ability
to sell products, provide services or use certain technologies.

Regulatory Risks

•

The need to obtain regulatory approvals, clearances, authorizations or certifications could increase our costs and adversely
affect our financial performance.

Failure to comply with FDA or other regulatory requirements may require us to suspend production or sale of our products
or institute a recall which could result in higher costs and loss of revenues.

Our inability to respond to changes in regulatory requirements could adversely affect our business.

We are subject to numerous government regulations in addition to FDA requirements, which could increase our costs and
affect our operations.

FDA regulation of laboratory-developed tests and genetic testing could affect demand for our products.

Risks Relating to the Economy, Our Financial Results, Investments, Credit Facilities and Need for Financing

•

We have experienced losses in the past and may not be able to again achieve and maintain profitable operations.

Economic volatility and disruption, including those related to the COVID-19 pandemic could adversely affect our business,
financial performance, results of operations, cash flow and financial condition or those of our customers and suppliers.

An impairment of goodwill and intangible assets could reduce our earnings.

Changes to foreign currency exchange rates could negatively affect our operating results.

Risks Relating to Our Common Stock

•

Our stock price could continue to be volatile.

Future sales of our Common Stock by existing stockholders, executive officers or directors could depress the market price
of our Common Stock and make it more difficult for us to sell stock in the future.

Certain provisions in our Certificate of Incorporation and Bylaws and under Delaware law could make a third-party
acquisition of us difficult.

You should carefully consider the risks and uncertainties described below. The risks and uncertainties described below are not the only
ones facing us. Additional risks and uncertainties not disclosed or not presently known to us or that we currently deem immaterial also
may impair our business operations. The occurrence of any of the following risks could harm our business, financial condition or results
of operations.

Risk Factors

Changes in the Genomics Market May Adversely Affect our Business.

Risks Relating to Products, Marketing and Sales

The genomics market has been the largest component of our overall molecular business segment for some time and the major drivers of
this market have been the consumer genomics segment, which offers products and services to consumers to provide them with
personalized health and genealogical information, and the disease risk management segment which offers genetic testing through
physicians for a variety of applications including prenatal testing, risk screening and pharmacogenomics. The ancestry portion of the
consumer genomics market may be maturing and our sales to customers with offerings in this market have been volatile. Our genomics
revenues have also been volatile due to changes in promotional strategies and purchasing patterns by one of our largest customers which
serves the consumer ancestry and genetic testing market and cost cutting and de-stocking efforts at some of our larger disease risk
management customers. These trends in the ancestry testing market may continue and revenues in this segment may continue to be
volatile.

In an effort to increase our molecular revenues, we have devoted increasing time and attention to expanding sales of our genomics
products both domestically and internationally, with both new and existing accounts, including co-clearances and co-promotions with
strategic partners. While we believe these new markets represent large growth opportunities, there is no assurance that we will be
successful in capitalizing on these opportunities or that we will be able to increase our product sales consistent with our expectations.
Factors include, but are not limited to, the market acceptance of our products, available funding, cost containment strategies implemented
by customers, increasing competition and regulatory constraints could limit sales of our genomics products. To the extent that we are
unsuccessful or limited in expanding our business into new markets, our revenues and results of operations could be negatively affected.

Despite these challenges, we believe there is significant growth opportunity for our genomics products in the area of disease risk
management (“DRM”), which includes genetic risk testing, prenatal testing, carrier screening, pharmacogenomics testing and population
heath studies.

Our Future Success Depends Upon Market Acceptance of Our Existing and Future Products and Service Offerings.

Our future success will depend, in part, on the market acceptance, and the timing of such acceptance, of new products such as
InteliSwab®, OraQuick® HIV Self-Test, OraQuick® Ebola test and OMNIgene® • GUT product offerings, and other new products or
technologies that may be developed or acquired. In addition, our future revenues will depend on market acceptance of new uses for our
saliva collection products, including for COVID-19 testing, and our new service offerings, such as the microbiome laboratory testing
and analytical services we provide through Diversigen. To commercially market new uses of our products and to achieve market
acceptance, we will likely be required to undertake clinical studies to validate the new uses for our products and spend significant funds
to complete product development and clinical studies and then undertake substantial marketing efforts to inform potential customers
and the public of the existence and perceived benefits of these products and services. In addition, governmental funding may be needed
to help complete development, obtain required regulatory approvals, clearances or EUAs and create market acceptance and expand the
use of these products and services.

There may be limited evidence on which to evaluate the market reaction to products and services that may be developed and our
marketing efforts for new products and services or products with new uses may not be successful. The market for microbiome products
and services is in its early stages and its future development and acceptance by our customers is uncertain. Also, we continue to develop
and seek 510(k) regulatory clearance for the InteliSwab® tests, and it is uncertain whether we will be successful in our development
and validation efforts or whether these products will prove effective, receive applicable regulatory approvals and gain widespread
acceptance in the marketplace. As such, there can be no assurance that any products or services will obtain significant market acceptance
and fill the market need that is perceived to exist on a timely basis, or at all. It is possible that our expenses to develop and market any
such products, including, without limitation our InteliSwab® tests, will exceed any benefit in revenues, which may be short-lived. In
addition, other products that compete with ours may achieve 510(k) clearance earlier than we do, providing market advantages.

We May Not Realize Anticipated Revenue From Our InteliSwab® COVID-19 Rapid Test.

While we expect to continue to see significant demand for our InteliSwab® COVID-19 Rapid Test, other companies are working to
produce or have produced rapid tests for COVID-19 which may lead to the diversion of customers, including governmental and quasi-
governmental entities, away from us and toward other companies. Moreover, the dangers posed by COVID-19 may subside over time.
A number of preventative vaccines have been approved for use in human populations by regulatory agencies in the U.S. and around the
world. The uptake of these vaccines will likely limit the spread of COVID-19 and potentially reduce the market size for COVID-19
testing.

We expect that, if and when the current COVID-19 pandemic subsides, there could be significantly reduced demand for testing, and
thus, for our InteliSwab® COVID-19 Rapid Tests. We have seen a reduction in the prevalence of COVID-19 since the height of the
pandemic, and we expect that revenues relating to our COVID-19 testing products will decline in the future if the prevalence of COVID-
19 remains low. Further, if the COVID-19 pandemic becomes a seasonal virus or experiences fluctuations in prevalence, we could
experience fluctuations in our revenues associated with our InteliSwab® COVID-19 Rapid Tests. While there is still demand for
COVID-19 testing products, there is no guarantee that current or anticipated demand will continue, or if demand does continue, that we
will be able to produce our InteliSwab® COVID-19 Rapid Test in quantities to meet the demand. A significant decline in demand for
our InteliSwab® COVID-19 Rapid Test without a corresponding increase in our other businesses could have a material, adverse effect
on our results of operations, cash flow and financial position.

The COVID-19 Pandemic Continues to Cast Uncertainty Over Our Consolidated Results of Operations, Financial Position and
Cash Flows, While the Consequences of COVID-19 and the Governmental Response to Contain the Pandemic and Pandemic-
Related Macroeconomic Impacts Could Negatively Affect Our Operations and Share Price.

Although we have experienced heavy demand for our InteliSwab® tests and certain specimen collection devices for use in COVID-19
molecular testing as a result of the COVID-19 pandemic, which has had a positive impact on our performance, the duration and level of
the demand for COVID-19 testing is highly uncertain. In addition, the COVID-19 pandemic has continued to negatively impact our
ability to provide our HIV self-tests in Southern and Eastern African countries due to logistics challenges and, in our Molecular Solutions
segment, COVID-related disruptions in clinical and research work, particularly in the academic market, had reduced demand for our
products. We believe the COVID-19 pandemic's continued impact on our consolidated results of operations, financial position and cash
flows will be primarily driven by; (i) the severity and duration of the COVID-19 pandemic; (ii) the COVID-19 pandemic's impact on
the U.S. healthcare system and the U.S. economy; (iii) the timing, scope and effectiveness of federal, state and local governmental
responses to the COVID-19 pandemic, including the development and deployment of vaccine, and (iv) the COVID-19 pandemic's impact
on global clinics, research markets and global logistics. Each of these factors are difficult to predict and the nature, length and severity
of any adverse consequences as a result of any given factor are uncertain.

Management has closely monitored the impact of the COVID-19 pandemic, with a focus on the health and safety of our employees and
business continuity.

In response to, or as a result of, the current COVID-19 pandemic and emergence of variants, we may experience, among other things,
voluntary or mandated temporary closures of one or more of our facilities; temporary or long-term labor shortages; temporary or long-
term adverse impacts on our supply chain and distribution channels; the potential of increased network vulnerability and risk of data
loss resulting from increased use of remote access and removal of data from our facilities; and required reallocation or adjustment of
resources, which may impact our business plans and product offerings. In addition, the direct or indirect impacts of COVID-19 may
extend to disrupt our suppliers, partners, manufacturers, customers and other stakeholders, which in turn could materially adversely
affect our business, results of operations or financial condition. Any change or disruption in operations could impact and have a material
adverse effect on our operations and/or results from operations. In addition, the re-introduction of voluntary or mandated efforts to slow
the spread of COVID-19 could impact our operations and sales. If portions or all of our, our partners’, or our customer’s operations are
disrupted or suspended as a result of preventative or reactionary measures in response to the ongoing spread of COVID-19, it could have
a material adverse impact on our profitability, results of operations, financial condition and share price. Further, there continue to be
significant economic and social impacts of the COVID-19 pandemic, including rising inflation rates, continued levels of higher
unemployment, and market volatility, among other impacts; any of which may have an impact on consumer behavior, including use of
our products.

Given the uncertainties associated with the ongoing COVID-19 pandemic, including the uncertainty surrounding the remaining duration
and outcome, COVID-19 variants and vaccine efficacy, we are unable to estimate the full impact of the COVID-19 pandemic on its
business, financial condition, results of operations, and/or cash flows; however, the impact could be material.

Marketing of Our COVID-19 Tests and Collection Kits Under EUAs From The FDA Is Subject To Certain Limitations and We
Are Required To Maintain Compliance With The Terms of The EUA, Among Other Things, And The Continuance of The EUAs
Is Subject To Government Discretion.

On February 4, 2020, the HHS issued a declaration that the threat to public health posed by COVID-19 justifies the emergency use of
unapproved in vitro diagnostics for the detection or diagnosis of SARS-CoV-2. Under Section 564 of the FDCA, because HHS has
issued this declaration, the FDA Commissioner is authorized to issue EUAs to permit certain developers of SARS-CoV-2 diagnostics
to begin offering the tests for detection and diagnosis of COVID-19 without having completed the normally applicable FDA review and
clearance or approval process for marketing authorization (with the related standards that would apply to demonstrate safety and
effectiveness). The issuance of an EUA reflects an FDA conclusion that based on the totality of scientific evidence available to the FDA,
it is reasonable to believe that the product may be effective in diagnosing COVID-19, the known potential benefits of the product

outweigh the known and potential risks, and there is no adequate, approved, and available alternative to the emergency use of the
product.

During 2020, our ORAcollect®·RNA and OMNIgene®·ORAL collection devices were included in EUAs granted by the FDA to certain
third parties for use in the detection of SARS-CoV-2, and we have separately obtained EUAs for these products. In addition, we obtained
three EUAs for our new our InteliSwab® COVID-19 Rapid Test. Although there are certain regulatory requirements the FDA has
waived for the duration of the EUAs, we remain subject to specific conditions of the authorization, including ensuring appropriate
labeling as approved by FDA specifically for purposes of the EUA, maintaining records of distribution to authorized laboratories,
collecting data on occurrences of any false positives or false negatives, and tracking any adverse events. As part of the conditions of
authorization, OraSure was required to conduct a clinical study in a pediatric population ages 2-14 and an asymptomatic population in
addition to launching an app for consumers to report their test results to public health jurisdictions. OraSure has completed the required
conditions of authorization with respect to the pediatric claim and launched the InteliSwab ® Connect application for reporting test
results to public health jurisdictions. As a result of the National Institutes of Health study (Performance of Screening for SARS-CoV-2
using Rapid Antigen Tests to Detect Incidence of Symptomatic and Asymptomatic SARS-CoV-2 Infection: findings from the Test Us
at Home prospective cohort study), FDA has requested modifications to labeling to include serial testing and has removed the required
for the Company to conduct a study in an asymptomatic population. Labeling has been modified as required for inclusion of serial
testing and authorized by FDA.

As with other FDA-regulated products, issues could emerge during the course of the marketing and use of our products under an EUA
that could impact our ability to continue the sale and distribution of these products (for example, compliance or product performance
issues). The applicable EUAs remain effective only until the HHS declaration is terminated or revoked, and the FDA may also revoke
an EUA if it determines the criteria for issuance are no longer met or other circumstances make such revocation appropriate to protect
the public health or safety.
If that were to occur then in order market our diagnostic products or collection kits for the purpose of
detecting COVID-19, we would be required to obtain the necessary regulatory clearances or approvals and be subject to the full and
usual regulatory obligations for device manufacturers, including the QSR under 21 CFR Part 820. It is possible that we may not be able
to obtain those clearances or approvals in a timely manner, or at all, and that one or more of our competitors may obtain the necessary
clearances or approvals for their products before we do.

If Acceptance and Adoption of Oral Fluid Testing and Collection Products Does Not Continue, Our Future Results May Suffer.

We have made significant progress in gaining acceptance of oral fluid testing products, particularly for (i) HIV testing in the public
health, hospital, insurance and other markets, and (ii) drugs-of-abuse testing in the workplace and criminal justice markets. Our
subsidiary, DNAG, has also made significant progress in gaining acceptance of oral fluid collection products that are used with molecular
testing applications including testing for SARS-CoV-2. However, the degree of acceptance for these products is uncertain, and one or
more markets may resist the adoption of oral fluid products as a replacement for other testing or collection methods in use today. As a
result, there can be no assurance that we will be able to expand the use of our oral fluid testing products in these or other markets.

However, clinical reference laboratories and hospital-based laboratories currently provide the majority of diagnostic tests used by
physicians and other healthcare providers in the U.S. In certain international markets such as Europe, diagnostic testing is performed
primarily by centralized laboratories. Our future sales will depend, in part, on our ability to expand market acceptance of rapid point-
of-care testing by physicians, other healthcare providers and consumers and successfully compete against laboratory testing methods
and products. Even if we can demonstrate that our products are more cost effective, save time, or have better performance or other
benefits, physicians, other healthcare providers and consumers may resist changing to rapid point-of-care tests and instead may choose
to obtain diagnostic results through laboratory tests. In addition, demand for our new rapid tests for SARS-CoV-2 or PrEP adherence
may not develop consistent with our expectations. Our failure to achieve and expand market acceptance of our rapid point-of-care
diagnostic tests with customers would have a negative effect on our future sales growth.

We Expect to Face Increasing Competition From Other Providers of Diagnostic Tests, Sample Collection Products and
Molecular Laboratory Services.

Our rapid point-of-care tests compete with other point-of-care products made by our competitors. This competition is particularly evident
with respect to our OraQuick ADVANCE® HIV-1/2 test and our HIV Self-Test outside of the US. The Oragene® product line sold by
our subsidiary, DNAG, competes against other molecular collection products, such as blood collection kits and buccal swabs and will
likely face additional competition from collection devices similar in design and operation to our Oragene® and ORAcollect® products.
There are a number of products currently in or expected to enter the market for the detection of antigen to SARS-CoV-2 that currently
or will compete with our InteliSwab® COVID -19 diagnostic test.

Our genetic and microbiome laboratory services business is expected to face increasing competition, primarily from large commercial
reference laboratories, hospital-based laboratories and specialty laboratories. We believe there is significant opportunity in the markets

for these services, particularly the microbiome market which is still in the early stages. As these markets evolve and expand, we expect
competition for genomic and microbiome laboratory services to intensify.

There is significant competition, including from other companies and governmental organizations, who make and distribute rapid tests
for COVID-19. Many of these entities have substantially greater resources (including capital and personnel) than we do. Even if we are
successful in marketing our InteliSwab® tests, there is no guarantee that competitors will not take market share from our offerings
through more effective marketing or competitive pricing, higher quality or technological superiority.

A number of our competitors are making investments in competing technologies, products and services, and several may have a
competitive advantage because of their greater financial, technical, research and other resources. Some competitors offer broader product
lines and service offerings, aggressively discount prices for their products and services and may have greater name recognition than we
have. We also face competition from certain of our distributors or former customers that have created, or may decide to create, their
own products to compete with ours. If our competitors take market share from our offerings through more effective marketing or
competitive pricing, higher quality or technological superiority, our revenues, margins and operating results could be adversely affected.
In addition, our revenues and operating results could be negatively impacted if some of our customers use internally developed or
acquired sample collection devices or services in order to reduce costs.

Our Product Sales Cycles Can be Lengthy, and May Depend on Public Funding, Which Can Cause Variability and
Unpredictability in Our Operating Results.

The sales cycles for certain of our products can be lengthy and unpredictable, which makes it more difficult to accurately forecast
revenues in a given period and may cause revenues and operating results to vary from period to period. Sales of our products often
involve purchasing decisions by large public and private institutions, may require many levels of approval and may be dependent on
economic or political conditions and the availability of grants or funding from governmental or public health agencies which can vary
from period to period in both amount and timing. For example, in past years our OraQuick ADVANCE® HIV-1/2 test has been purchased
through bulk procurement or other funding provided by governmental agencies. Our OraQuick® HCV test has been purchased by
customers who receive government funding, and we believe increased funding from the CDC and other agencies will be required to
substantially increase the volume of HCV testing, especially in the public health market. There can be no assurance that purchases or
funding from these agencies will occur or continue. As a result, we may expend considerable resources on unsuccessful sales efforts or
we may not be able to complete transactions at all or on a schedule and in an amount consistent with our objectives.

Our Inability To Expand International Sales Could Adversely Affect Our Business and Results of Operations.

One of our strategic priorities is to substantially expand our product sales internationally. An opportunity to accomplish this objective
is with the sale of our OraQuick® HIV Self-Test in support of large self-testing programs in certain African countries and elsewhere.
Our OraQuick® HIV Self-Test is also currently available in six European countries: United Kingdom, Germany, France, Italy, Spain
and Portugal. We are also working to expand international sales of our professional HIV and HCV products and our molecular collection
kits. We also believe there is a significant opportunity for international sales of our InteliSwab® COVID-19 Rapid Test once the
necessary studies and registrations are complete.

While we believe international sales of these and other products represent attractive long-term opportunities with significant growth
potential, there is no guarantee that these opportunities will materialize, continue or increase. Among other factors, competition from
competitive lower priced products and the uncertainties of available funding could negatively impact the success of these opportunities.
If international sales of these products do not occur or increase or if we are otherwise unable to expand international sales of our products,
our revenues and results of operations could be negatively impacted.

In addition, market conditions in many countries often require that we sell our products at a price below our typical U.S. or European
pricing in order to participate in these markets. As a result, sales in certain countries may contribute lower profit margins to our business.
To the extent these international sales comprise a large or increasing part of our business, our gross margins will be negatively affected.
In addition, we may have difficulty selling our products at a sufficiently low price to maintain or increase this business over the long
term without funding support from public health entities, government agencies or other sources. If we are unable to obtain or continue
this funding support at sufficient levels, or at all, our revenues and results of operations could be negatively affected.

Our International Presence May Increase Our Risks and Expose Our Business to Regulatory, Cultural or Other Restraints.

We seek to increase revenue derived from international sales of our products. Our international sales accounted for $37.3 million, or
10% of consolidated net revenues in 2022, $45.3 million, or 24%, of consolidated net revenues in 2021, and $40.9 million, or 24%, of
consolidated net revenues in 2020. In addition, our subsidiary DNAG, which accounted for $75.0 million or 19% of consolidated net

revenues in 2022, is operated in Canada. We have previously acquired foreign companies and we may acquire other foreign companies
as part of our business development efforts.

A number of factors could adversely affect the performance of our business and/or cause us to incur substantially increased costs because
of our international presence and sales, including, but not limited to those set forth below:

•

Uncertainty in the application of foreign laws and the interpretation of contracts with foreign parties;

The potential for inconsistent imposition of legal and regulatory requirements;

Cultural and political differences that favor local competitors or make it difficult to effectively market, sell and gain
acceptance of our products;

Cultural and language differences that make international operations and business management more difficult;

Inexperience in international markets and territories and difficulties in staffing and managing foreign operations;

Exchange rates, currency fluctuations, tariffs and other barriers, extended payment terms and dependence on international
distributors or representatives;

Regulatory requirements, including compliance with applicable customs regulations and the need to obtain or maintain
regulatory approvals, registrations or reimbursement approvals for our products;

Trade protection measures, additional trade sanctions and import/export licensing requirements;

The inability to obtain or maintain ISO certification for our or our suppliers’ manufacturing facilities;

Our inability to identify international distributors and negotiate acceptable terms for distribution agreements;

Diversion to the U.S. of our products that are sold at lower prices into international markets;

The loss of one or more distributors and difficulties or delays in obtaining new or transferred product registrations or
approvals for use by a replacement distributor;

Differing tax laws across jurisdictions, as well as changes in those laws;

An increase of withholding and other taxes on remittances and other payments by a foreign subsidiary;

The creditworthiness of foreign distributors and customers and difficulty in collecting foreign accounts receivable;

Difficulty of enforcing contractual obligations or recovering damages under foreign legal systems;

Difficulty collecting amounts owed by foreign governments or other customers;

Economic conditions, inflation, political instability, the absence of available funding sources, terrorism, civil unrest, war
and natural disasters in foreign countries;

Exposure to infectious disease and epidemics, including the effects of the COVID-19 outbreak on our business operations
in geographic locations impacted by the outbreak and on the business operations of our customers and suppliers;

Long sales cycles in international markets, especially for sales to foreign governments, quasi-governmental agencies and
international public health agencies;

The sale of competing products by foreign competitors at prices at or below the prices we offer for our products;

Restrictions on our ability to repatriate investments and earnings from foreign operations;

Changes in shipping costs;

The unavailability of licenses to certain patents in force in a foreign country which cover our products; and

Reduced protection for, or enforcement of, our patents and other intellectual property rights in foreign countries.

In addition, we have contracted with a third party in Thailand for the manufacture of a portion of our OraQuick® HIV tests and a portion
of the assembly of our InteliSwab® COVID-19 Rapid Tests, and all of DNAG’s products are produced in Canada. We may enter into
agreements to manufacture these or other products in additional foreign countries as well. However, economic, cultural and political
conditions and foreign regulatory requirements may slow or prevent the manufacture of our products in countries other than the United
States. Interruption of the supply of our products could reduce revenues or cause us to incur significant additional expenses in finding
an alternative source of supply. Foreign currency fluctuations and economic conditions in foreign countries could also increase the costs

of manufacturing our products in foreign countries. In addition, the ongoing COVID-19 pandemic has resulted in increased government-
imposed travel restrictions and extended shutdowns of certain businesses in the affected locations as well as logistics delays due to the
global logistical crisis from the pandemic. These or any further political or governmental responses to pandemic diseases could result
in social, economic and labor instability of foreign countries, which could have a material adverse effect on our business, results of
operations and financial condition.

Our U.S. Government Contracts Require Compliance With Numerous Laws and Increases Our Risk and Liability.

From time to time, we receive funding from the U.S. government and we sell some of our products to the federal government.
Historically, we have sold a number of our products to the government under contracts with the General Services Administration and
the Veterans Administration.

In September 2022 we entered into an $8.6 million contract with BARDA to develop a second generation Ebola test on the OraQuick®
testing platform and we were selected to provide our OraQuick® In-Home HIV tests in support of the CDC "Together Take me Home,"
HIV self-test program. Under the program, the CDC is expected to provide $41.5 million over a five-year period to support community
testing. During the third quarter of 2022, we entered into a contract with the DLA for the second procurement of our InteliSwab®
COVID-19 Rapid Test for OTC use. During the same quarter, we entered into a contract with the BARDA to provide us with up to
$13.6 million in funding to obtain FDA 510(k) clearance and CLIA waiver for our InteliSwab® test. In September 2021, we entered
into a contract with the U.S. Department of Defense, in coordination with the HHS for $109 million in funding to build additional
manufacturing capacity in the United States for our InteliSwab® test.

As a result of our U.S. government funding and product sales to the U.S. government, we must comply with laws and regulations relating
to the award, administration and performance of U.S. government contracts. U.S. government contracts typically contain a number of
extraordinary provisions that would not typically be found in commercial contracts and which may create a disadvantage and additional
risks to us as compared to competitors that do not rely on government contracts. For example, the government has the right to terminate
one or more of these contracts at its convenience even if we have not defaulted in any of our obligations.

As a U.S. government contractor, we are subject to increased risks of investigation, criminal prosecution and other legal actions and
liabilities to which purely private sector companies are not. The results of any such actions could adversely impact our business and
have an adverse effect on our consolidated financial performance.

A violation of specific laws and regulations could result in the imposition of fines and penalties or the termination of our contracts, as
well as suspension or debarment. The suspension or debarment in any particular case may be limited to the facility, contract or subsidiary
involved in the violation or could be applied to our entire enterprise in certain severe circumstances. Even a narrow scope suspension or
debarment could result in negative publicity that could adversely affect our ability to renew contracts and to secure new contracts, both
with the U.S. government and private customers, which could materially and adversely affect our business and results of operations.
Fines and penalties could be imposed for failing to follow procurement integrity and bidding rules, employing improper billing practices
or otherwise failing to follow rules relating to billing on cost-plus contracts, receiving or paying kickbacks, or filing false claims, among
other potential violations. In addition, we could suffer serious reputational harm and the value of our common stock could be negatively
affected if allegations of impropriety related to such contracts are made against us.

Our Inability to Manufacture Products in Accordance with Applicable Specifications, Performance Standards or Quality
Requirements Could Adversely Affect Our Business.

The materials and processes used to manufacture our products must meet detailed specifications, performance standards and quality
requirements to ensure our products will perform in accordance with their label claims, our customers’ expectations and applicable
regulatory requirements. As a result, our products and the materials used in their manufacture or assembly undergo regular inspections
and quality testing. Factors such as defective materials or processes, mechanical failures, human errors, environmental conditions,
changes in materials or production methods, and other events or conditions could cause our products or the materials used to produce
or assemble our products to fail inspections and quality testing or otherwise not perform in accordance with our label claims or the
expectations of our customers.

Any failure or delay in our ability to meet the applicable specifications, performance standards, quality requirements or customer
expectations could adversely affect our ability to manufacture and sell our products or comply with regulatory requirements. These
events could, in turn, adversely affect our revenues and results of operations.

Our Business Will Suffer if We Do Not Effectively Manage Challenges to Our Manufacturing Processes and We May be
Unable to Successfully Scale-Up Manufacturing of Our Products in Sufficient Quality and Quantity to Meet Demand, Which
Would Negatively Impact Revenue Expectations.

Challenges in the manufacture of our products in the face of significant demand for our InteliSwab® COVID-19 Rapid Tests have
adversely affected, and could in the future adversely affect, our operating efficiency and results of operations. We have contracted with
the U.S. Department of Defense to add additional manufacturing capacity of our InteliSwab® COVID-19 Rapid Tests. However, we
face risks, including with respect to expanding our overall production capacity, that could increase costs, divert management attention
and reduce our operating results, with no guarantee of success. The expansion of our manufacturing and scale-up of additional
commercial production and capacity involves significant risks and challenges, including, but not limited to, design and construction
delays, implementation of new systems and expertise and cost overruns. There can be no assurance that our scale-up and manufacturing
expansion will be operational, on time, or contribute the production capacity that we anticipate, and we cannot guarantee that any such
scale-up will operate at costs acceptable to us or that demand for our products will remain at levels high enough to meet the return on
investment necessary to justify our investment in these projects.

As we increase our manufacturing capacity to meet market demand or begin to manufacture new products at scale, we may face
unanticipated manufacturing challenges as production volumes increase, new processes are implemented and new supplies of raw
materials used in these products are secured. In addition, we could experience delays in production as we increase our manufacturing
capacity or begin to manufacture new products that may result in our inability to meet product demand as the products ordered by our
customers being on back-order as initial production issues are addressed. If we experience production delays or inefficiencies, a
deterioration in the quality of our products or other complications in managing changes to our manufacturing processes, including those
that are designed to increase capacity, enhance efficiencies and reduce costs or that relate to new products or technologies, we may not
achieve the benefits that we anticipate from these actions when expected, or at all, and our operations could experience disruptions, our
manufacturing efficiency could suffer and our business, financial condition and results of operations could be materially and adversely
affected. Any such delays could allow our competitors to seize market advantage.
In addition, global supply chain and workforce
challenges related to the COVID-19 pandemic increase the risks in scaling-up manufacturing as global supply challenges may increase
the difficulty in obtaining necessary materials and a dynamic and unpredictable labor market may make the necessary labor and staffing
challenges more difficult. If we are unable to successfully meet our manufacturing challenges, we may be unable to meet the demand
for our InteliSwab® COVID-19 Rapid Tests, which could have a material, adverse effect on our reputation, revenues, results of
operations, cash flow and financial position.

Our Business Results Depend on our Ability to Manage Disruptions in our Domestic and Global Supply Chains and
Distribution Channels.

Our ability to meet our customers needs and achieve our financial objectives depends on our ability to maintain key manufacturing,
supply and distribution arrangements. The loss or disruption of such manufacturing and supply arrangements could, in the future,
interrupt our ability to obtain necessary raw materials and manufacture our products. Such disruptions could result from labor disputes,
financial liquidity, natural disasters, extreme weather conditions, public health emergencies and pandemics, supply constraints and
general economic and political conditions that could limit the ability of our suppliers to timely provide us with raw materials and
components and distribute our products in a timely manner in accordance with applicable quality requirements. Disruptions in the global
supply chain could also delay or preclude the ability of our distributors to sell and deliver our products to customers.

The availability and price of these materials, parts, products and services are affected by a variety of factors beyond our control, including
the willingness of suppliers to sell into the medical device industry, changes in supply and demand, general economic conditions, labor
costs, fuel-related transportation costs, liability concerns, climate change (including new and existing laws and regulations to address
climate change), competition, import duties, tariffs, currency exchange rates, inflationary pressures and political uncertainty around the
world. Our suppliers often pass some of their cost increases on to us, and if such increased costs are sustained or increase further, our
suppliers may pass further cost increases on to us. In addition, transportation costs have generally increased and may further increase if
crude oil prices increase. Our transportation and service providers are typically able to pass any significant increases in oil prices on to
us. Our costs may also be impacted by laws to increase minimum wages, including the potential increase to the federal minimum wage
in the United States that has been recently proposed by the current administration.

Our ability to recover such increased costs may depend upon our ability to raise prices on our products. Due to the highly competitive
nature of the healthcare industry and the cost-containment efforts of our customers and third-party payers, we may be unable to pass
along cost increases through higher prices. If we are unable to fully recover these costs through price increases or offset these increases
through cost reductions, or we experience terminations or interruption of our relationships with our suppliers, we could experience lower
margins and profitability, and our results of operations, financial condition and cash flows could be materially harmed.

Recently, the global supply chain has experienced significant disruptions caused by the COVID-19 pandemic, resulting in shortages of
labor and equipment. These conditions, if not mitigated or remedied in a timely manner, could delay or preclude delivery of raw materials
needed to manufacture our products or delivery of our products to customers, particularly in international markets. This in turn could
have an adverse impact on our business, financial condition, results of operations or cash flows.

Certain of Our Products Depend on Components From a Sole-Source Supplier, the Loss of Which Would Cause Us To Be
Unable to Deliver Such Products.

Our Intercept i2®he collection device is manufactured and supplied under a long-term agreement with Thermo Fisher, the sole-source
supplier for these products. If Thermo Fisher were unable or unwilling to supply the necessary components for the manufacture of the
Intercept i2® he collection devices, we would be unable to produce this product or offer it to our customers. Any interruption in, or
change in the cost or quality of, the supply of the necessary raw materials, manufacturing services, product and process development,
or other materials necessary to manufacture the product could adversely impact the efficacy of the product and negatively affect our
reputation with our customers. In addition, many of the raw materials used in our DNAG products, including our Oragene® product line,
and components used in these products are also purchased from third parties, some of which are purchased from a sole source supplier.
If our sole source suppliers were to be acquired by a competitor, they may elect not to provide us with the product, raw materials or
other components, as applicable. If our sole source suppliers were to otherwise cease supplying us, go out of business, or were unable
to meet their obligations in a timely fashion or at an acceptable price, or at all, we may be forced to incur higher costs to obtain the
necessary raw materials elsewhere, if we could even source such materials at all.

Our U.S. Government Contracts May Affect our Intellectual Property Rights.

Provisions in our U.S. government contracts may affect our intellectual property rights. Certain of our activities have been funded, and
may in the future be funded, by the U.S. government, including our contracts with BARDA. When new technologies are developed with
U.S. government funding, the government obtains certain rights in any resulting patents, including the right to a nonexclusive license
authorizing the government to use the invention. These rights may permit the government to disclose our confidential information to
third parties and to exercise “march-in” rights to use and allow third parties to use our patented technology. The government can exercise
its march-in rights if it determines that action is necessary because we fail to achieve practical application of the U.S. government-
funded technology, because action is necessary to alleviate health or safety needs, to meet requirements of federal regulations, or to give
preference to U.S. industry. In addition, government-funded inventions must be reported to the government, government funding must
be disclosed in any resulting patent applications, and our rights in such inventions may be subject to certain requirements to manufacture
products in the United States.

Our U.S. Government Contracts and Related Administrative Processes Are Subject to Audits and Cost Adjustments by the
Federal Government.

Federal government agencies can audit and investigate government contracts and the administrative processes and systems of
government contractors. These agencies can review our performance on government contracts, pricing practices, cost structure, and
compliance with applicable laws, regulations and standards. They can also review our compliance with government regulations and
policies and the adequacy of our internal control systems and policies, including our purchasing, accounting, estimating, compensation
and management information processes and systems. Any costs found to be improperly allocated to a specific government contract,
unallowable or unreasonable will not be reimbursed, and any such costs already reimbursed may be required to be refunded and certain
penalties may be imposed. Adjustments arising from government audits and reviews could have a material adverse effect on our business,
financial condition, results of operations and prospects.

Moreover, if any administrative process or system related to such contracts is found not to comply with governmental requirements, we
may be subjected to government scrutiny that could delay or otherwise adversely affect our ability to compete for or perform government
contracts or collect our revenue in a timely manner. An unfavorable outcome of an audit of our government contracts could adversely
affect our results of operations.

We May Not be Able to Fulfill Our Obligations Under Government Contracts, Which Could Result in Reduced Sales and
Profits, Contract Penalties or Terminations, and Damages to Customer Relationships.

If we are unable to successfully scale-up our manufacturing of our InteliSwab® COVID-19 Rapid Tests, we may be unable to meet our
obligations under our government contracts. In addition, certain of our government contracts require us to meet production and
manufacturing milestones. Failure to meet these milestones would result in not receiving payments under the contract. Our inability to
fulfill our obligations under government contracts could result in reduced sales and profits, contract penalties or terminations, and
damage to customer relationships, leading the government to turn to other companies to fulfill the contract.

Risks Relating to Our Industry, Business and Strategy

Consolidation in the Healthcare Industry Could Adversely Affect Our Future Revenues and Operating Results.

The healthcare industry has experienced a significant amount of consolidation. As a result of this consolidation, competition to provide
goods and services to customers has increased. In addition, group purchasing organizations and integrated health delivery networks have
served to concentrate purchasing decisions for some customers, which has also placed pricing pressure on medical device suppliers. We
may not be able to compete successfully in such a consolidated industry. We believe industry consolidation may continue as companies
attempt to strengthen or hold their market positions and as more companies are acquired or cease operating. Further consolidation in the
industry could exert additional pressure on the prices of our products.

Our Research, Development and Commercialization Efforts May Not Succeed and Our Competitors May Develop and
Commercialize More Effective or Successful Offerings.

In order to remain competitive, we must regularly commit substantial resources to research and development and the commercialization
of new or enhanced products and services. The research and development process generally takes a significant amount of time from
inception to commercial launch. This process is conducted in various stages. During each stage there is a substantial risk that we will
not achieve our goals on a timely basis, or at all, and we may have to abandon a new or enhanced product or service in which we have
invested substantial time and money.

Successful products and services can require significant development and investment, including testing to demonstrate their performance
capabilities, cost-effectiveness or other benefits prior to commercialization. Regulatory approval or clearance must be obtained before
most products may be sold and additional development efforts on these products may be required before any regulatory authority will
review them. Similarly, regulatory clearances or registrations, such as a CLIA certification, and compliance with industry guidelines,
may be required in order to provide competitive laboratory services. As noted above, regulatory authorities may not issue such
approvals, clearances or certifications or may substantially delay or condition such action. Even if a product or service is developed and
all applicable regulatory approvals, clearance or certifications are obtained, there may be little or no market for the product or service
and entry into or development of new markets for our products and services may require an investment of substantial resources, such as
new employees, offices and manufacturing facilities. Moreover, we may spend a significant amount of money on manufacturing
facilities, advertising or other activities and fail to develop a market for the product or service. Other factors that could affect the success
of our efforts include our ability to manufacture products or provide laboratory services in a cost-effective manner and whether we can
obtain necessary intellectual property rights and protection in the markets where the product or service is sold.

If we fail to develop and gain commercial acceptance for our products and services, or if competitors develop more effective products
and services or a greater number of successful new products and services, customers may decide not to purchase our products and
services or may purchase and use products and services developed by our competitors. This would result in a loss of revenues and
adversely affect our results of operations, cash flow and business.

Customer Concentration Creates Risk for Our Business.

One of our customers accounted for approximately 58% of our net consolidated revenues for the year ended December 31, 2022. We
expect that sales to the large non-commercial customer will continue to be a significant contributor to our net consolidated revenue.
Certain parts of our business may continue to have a high customer concentration and depend disproportionately on a few large
customers. To the extent that such a large customers fail to meet their purchase commitments, change their ordering patterns or business
strategies, or otherwise reduce their purchases or stop purchasing our products, or if we experience difficulty in meeting the high demand
by these larger customers for our products, our revenues and results of operations could be adversely affected.

Acquisitions or Investments May Not Generate the Expected Benefits and Could Disrupt Our Ongoing Business, Distract Our
Management, Increase Our Expenses and Adversely Affect Our Business.

Since the beginning of 2019, we have acquired several companies through which we have gained access to new technologies, products
and services which are complementary to our existing business and aligned with our long-term business strategy. We will likely continue
to pursue strategic acquisitions or investments as a way to expand our business. These activities, and their impact on our business, are
subject to many risks, including the following:

•

Suitable acquisitions or investments may not be found or consummated on terms or schedules that are satisfactory to us or
consistent with our objectives;

We may be unsuccessful in competing for acquisitions with other entities, some of which have greater financial resources
or may be better able to realize synergies with a potential target;

•

The benefits expected to be derived from an acquisition or investment may not materialize and could be affected by
numerous factors, such as regulatory developments, insurance reimbursement, our inexperience with new businesses or
markets, general economic conditions and increased competition;

We may be unable to successfully integrate an acquired company’s personnel, assets, management, information technology
systems, accounting policies and practices, products, services and/or technology into our business;

Worse than expected performance of an acquired business may result in the impairment of intangible assets;

Acquisitions may require substantial expense and management time and could disrupt our business;

We may not be able to accurately forecast the performance or ultimate impact of an acquired business;

We may have difficulties in coordinating geographically separate organizations;

We may fail to successfully manage relationships with customers, distributors and suppliers of an acquired business;

An acquisition may result in a diversion of resources from our existing products, business and technologies;

An acquisition and subsequent integration activities may require greater capital and other resources than originally
anticipated at the time of acquisition;

To the extent we agree to pay contingent consideration for an acquisition, if and how much of such consideration we are
required to pay may be subject to dispute, resulting in the distraction of our management team and the incurrence of legal
costs;

An acquisition may result in employee anxiety, morale and/or engagement issues;

An acquisition may result in disparate information technology, internal control, financial reporting and record-keeping
systems;

An acquisition may result in new partners or customers who may operate on terms and programs different than ours;

An acquisition may result in employees not familiar with our operations;

An acquisition may result in new products and services, including the risk that any underlying intellectual property
associated with such products and services may not have been adequately protected or that such products and services may
infringe on the proprietary rights of others;

An acquisition may result in the incurrence of unexpected expenses, stockholder lawsuits, the dilution of our earnings or
our existing stockholders’ percentage ownership, or potential losses from undiscovered liabilities not covered by an
indemnification from the seller(s) of the acquired business;

An acquisition may result in the loss of our or the acquired company’s key personnel, customers, distributors or suppliers;
and

An acquisition of a foreign business may involve additional risks, including, but not limited to, foreign currency exposure,
liability or restrictions under foreign laws or regulations, and our inability to successfully assimilate differences in foreign
business practices or overcome language or cultural barriers and other inherent risks of operating in unfamiliar legal and
regulatory environments.

The occurrence of one or more of the above or other factors may prevent us from achieving all or a significant part of the benefits
expected from an acquisition or investment. This may adversely affect our financial condition, results of operations and ability to grow
our business or otherwise achieve our financial and strategic objectives.

There Are Risks Relating To Our Recent Acquisitions.

The success of the acquisitions will depend, in part, on our ability to successfully combine and integrate our legacy business with those
businesses acquired. The integration of the businesses with our existing business can be complex, costly and time-consuming processes.
It is possible that a number of factors, including, without limitation, the loss of key employees, higher than expected costs, diversion of
management attention and resources, the disruptions of ongoing businesses or inconsistencies in standards, controls, procedures and
policies, could adversely affect our ability to maintain relationships with customers, vendors and employees or to achieve the anticipated
benefits and cost savings of the acquisitions. If we experience difficulties with the integration process, the anticipated benefits of the
acquisitions may not be realized fully or at all, or may take longer to realize than expected. These integration matters could have an
adverse effect on us for an undetermined period following the acquisitions.

As a general matter, the market for microbiome laboratory testing and analytical services provided by Diversigen is at an early stage
In addition, the Colli-Pee® urine collection devices manufactured and sold by Novosanis are relatively new
and is still developing.
products that are not yet widely accepted by customers. There is no assurance that we will be successful in creating or expanding demand
for these services and products. To the extent that the markets for these services and products fail to develop or increase, our revenues
and results of operations could be adversely affected and we may not meet our growth objectives.

Our Revenues Could be Affected by Third-Party Reimbursement Policies and Potential Cost Constraints.

The end-users of certain of our products include hospitals, physicians and other healthcare providers. Use of our products could be
adversely impacted if these end-users do not receive adequate reimbursement for the cost of our products from their patients’ healthcare
insurers or payors. Our net sales could also be adversely affected by changes in reimbursement policies of governmental or private
healthcare payors, including in particular the level of reimbursement for our products.

In the United States, hospitals, physicians and other healthcare providers who purchase diagnostic products generally rely on third-party
payors, such as private health insurance plans, Medicare and Medicaid, to reimburse all or part of the cost of the product and procedure.
The overall escalating cost of medical products and services has led to, and will continue to lead to, increased pressures on the healthcare
industry, both foreign and domestic, to reduce the cost of products and services. Given the efforts to control and reduce healthcare costs
in the United States in recent years, currently available levels of reimbursement may not continue to be available in the future for our
existing products or products under development. Third-party reimbursement and coverage may not be available or adequate in either
the United States or international markets, current reimbursement amounts may be decreased in the future and future legislation, and
regulation or reimbursement policies of third-party payors, may reduce the demand for our products or our ability to sell our products
on a profitable basis. In addition, the reimbursement approval process may delay the market introduction of our products.

Changes in Healthcare Regulation Could Affect Our Revenues, Costs and Financial Condition.

In recent years, there have been numerous initiatives at the federal and state level for comprehensive reforms affecting the payment for,
the availability of and reimbursement for healthcare services in the United States. These initiatives have ranged from proposals to
fundamentally change federal and state healthcare reimbursement programs, including providing comprehensive healthcare coverage to
the public under government-funded programs, to minor modifications to existing programs. One example is the Patient Protection and
Affordable Care Act, the Federal healthcare reform law enacted in 2010 (the “Affordable Care Act”). Similar reforms may occur
internationally.

Legislative and regulatory bodies are likely to continue to pursue healthcare reform initiatives in many forms and may continue to reduce
funding in an effort to lower overall federal healthcare spending. The ultimate content and timing of changes to healthcare reform
legislation and the resulting impact on us are impossible to predict. If significant reforms continue to be made to the healthcare system
in the United States, or in other jurisdictions, those reforms may increase our costs or otherwise have an adverse effect on our financial
condition and results of operations.

New or Changed Testing Guidelines Could Affect Sales of Our Diagnostic Products.

From time to time, governmental agencies such as the CDC issue diagnostic testing guidelines or recommendations, which can affect
the usage of our HIV and HCV tests or other diagnostic products. For example, past sales of domestic professional OraQuick® HIV tests
have decreased in part due to customer migration to automated fourth generation HIV immunoassays performed in a laboratory, as
recommended under testing guidelines issued by the CDC. In addition, some states have promulgated, or may in the future promulgate,
laws and regulations that affect HIV or HCV testing. The issuance of new laws or guidelines, or changes in existing laws or guidelines,
and the manner in which these new or changed laws and guidelines are interpreted and applied by healthcare practitioners, could impact
the degree to which our OraQuick® rapid HIV and HCV testing products or other products are used. New or changed laws or guidelines
could affect the number of people tested, the frequency of testing and whether testing products such as our OraQuick® HIV and HCV
tests are used broadly for screening large populations or in a more limited capacity as a confirmatory test or otherwise. These factors
could in turn affect the level of sales of our products and our results of operations.

Reductions in Government Funding and Research Budgets Could Adversely Affect Our Business and Financial Results.

We sell our OraQuick ADVANCE® HIV-1/2 and OraQuick® HCV tests into the US public health market which consists of state, county
and other governmental public health agencies, community based organizations, service organizations and similar entities. We also sell
these products into the hospital market. Many of these customers depend to a significant degree on grants or funding provided by
governmental agencies to run their operations including programs that use our products. In international markets, we often sell products
such as our OraQuick® HIV Self-Test to or through foreign governmental agencies or parties funded by such agencies.

Many of our molecular collection products are sold to researchers at academic institutions, pharmaceutical and biotechnology
companies, government laboratories and private foundations. Many research customers are dependent for their funding on grants from
U.S. governmental agencies such as the U.S. National Institutes of Health and agencies in other countries to pay for the products and
services they purchase. These research customers also purchase our genomic and microbiome laboratory tests and analytical services.

The level of available government grants or funding in the U.S. and elsewhere is unpredictable and may be affected by various factors
including economic conditions, legislative and regulatory developments, political changes, civil unrest and changing priorities for
research and development activities. Further, government proposals to reduce or eliminate budgetary deficits have sometimes included
reduced allocations to government agencies in the U.S. and other countries that fund life sciences research and development activities.
Any reduction or delay in government or other funding as a result of legislative or regulatory changes or other factors, could cause our
customers to delay, reduce or forego purchases of our products and services.

Risks Relating to Our Reliance on Third Parties

The Use of Third Party Supply Sources For Critical Components of Our Products Could Adversely Affect Our Business.

We currently purchase certain critical components of our products from sole supply sources or other third-party suppliers. For example,
the biological antigens and antibodies, nitrocellulose and certain other components required to make our OraQuick® HIV, HCV and
Ebola products are currently purchased from sole source suppliers. Our OraSure QuickFlu® test and the fully automated high-throughput
drug assays sold with our Intercept i2® device are manufactured and supplied by sole source suppliers and the conjugates used in our
MICROPLATE oral fluid drugs-of-abuse assays are obtained from third-party suppliers. We have contracted with third parties in
Thailand for parts of the assembly of OraQuick® HIV device and the OraQuick® HIV Self-Test in order to supply certain international
markets. In addition, our subsidiary, DNAG, uses three third-party manufacturers to supply virtually all of its products, including its
Oragene® and ORAcollect® lines of collection kits. Many of the raw materials and components used in its products are also purchased
from third parties, a critical one of which is obtained from a sole source supplier.

The COVID-19 pandemic and the measures taken to contain the spread of the virus, have disrupted, and could continue to disrupt, the
normal operations of our third-party suppliers. Our third-party suppliers may not have the personnel, raw materials, capacity or capability
to manufacture our products according to our schedule and specifications. To the extent any such production and distribution interruption
or closures occur and continue for an extended period of time, the impact on our supply chain could have a material adverse effect on
our results of operations. If our third-party suppliers are unable or unwilling to supply or manufacture a required component or product
or if they make changes to a component, product or manufacturing process or do not supply materials meeting our specifications, we
may need to find another source and/or manufacturer. This could require that we perform additional development work and it may be
difficult to find such an alternate supply source in a reasonable time period or on commercially reasonable terms, if at all. We may also
need to obtain FDA or other regulatory approvals for the use of an alternative component or for changes to our products or manufacturing
process. Completing that development and obtaining such approvals could require significant time and expense and such approvals may
not occur at all. The availability of critical components and products from sole supply sources or other third parties could also reduce
our control over pricing, quality and timely delivery. These events could either disrupt our ability to manufacture and sell certain of our
products into one or more markets or completely prevent us from doing so, and could increase our costs. Any such event could have a
material adverse effect on our results of operations, cash flow and business.

Our Failure to Maintain Existing Distribution Channels, or Develop New Distribution Channels, May Result in Lower Revenues.

We have marketed many of our products by collaborating with laboratories, diagnostic companies and distributors. Our sales depend to
a substantial degree on our ability to sell products to these customers and on the marketing and distribution abilities of the companies
with which we collaborate.

Relying on distributors or others to market and sell our products could harm our business for various reasons, including:

•

We may not be able to find suitable distributors to distribute our products on satisfactory terms, or at all;

Our distributors or other customers may not fulfill their contractual obligations to us or otherwise market and distribute our
products in the manner or at the levels we expect;

We do not control the incentives provided by our distributors to their sales personnel and the effectiveness of these incentives
could affect sales of our products;

Agreements with distributors may terminate prematurely due to disagreements or may result in litigation between the parties;

We may not be able to renew existing distribution agreements on acceptable terms, or at all;

•

Our distributors may not devote sufficient resources or priority to the sale of our products;

Our distributors may prioritize their own private label products that compete with our products;

Our existing distributor relationships or contracts may preclude or limit us from entering into arrangements with other
distributors; and

We may not be able to negotiate future distribution agreements on acceptable terms, or at all.

Although we will try to maintain and expand our business with distributors and customers and require that they fulfill their contractual
obligations, there can be no assurance that such companies will do so or that new distribution channels will be available on satisfactory
terms. As a result, our revenues and business could be adversely affected.

We May Need Strategic Partners to Assist in Developing and Commercializing Some of Our Products.

Although we may elect to pursue some product opportunities independently, opportunities that require a technology controlled by a third
party, a significant level of investment for development and commercialization or a distribution network beyond our existing sales force
may necessitate involving one or more strategic partners. Further, our ability to enter into agreements with additional strategic partners
depends in part on convincing them that our products can help achieve and accelerate their goals and efforts. Our strategy for
development and commercialization of products may entail entering into arrangements with distributors or other corporate parties,
universities, research laboratories, government agencies, licensees and others. Relying on collaborative relationships could be risky to
our business for a number of reasons, including:

•

We may be required to transfer material rights to such strategic collaborators, government agencies, licensees and others;

Our collaborators may not devote sufficient resources or attach a sufficiently high priority to the success of our collaboration;

Our collaborators may not obtain regulatory approvals necessary to continue the collaborations in a timely manner;

We have limited access to our collaborator’s confidential corporate information and sudden unexpected changes in
ownership or strategy or other material events affecting a collaborator of which we are not made aware of in a timely
manner, or at all, could adversely impact our relationship;

Our collaborators may be acquired by another company, sell the part of their business related to our collaboration, decide
to terminate our collaborative arrangement or become insolvent;

Our collaborators may develop technologies or components competitive with our products;

Our collaborators may fail to deliver technologies or components that satisfy market requirements or such products may fail
to perform properly;

Disagreements with collaborators could result in the termination of the relationship or litigation;

Collaborators may not have sufficient capital resources; and

We may not be able to negotiate future collaborative arrangements, or renewals of existing collaborative agreements, on
acceptable terms or at all.

While we generally expect that our collaborative partners will have an economic motivation to succeed in performing their contractual
responsibilities, there is no assurance that they will do so, either at the level required or at all, and the amount and timing of resources
to be devoted to these activities will be controlled by others. Reliance on strategic agreements can also make it difficult to accurately
forecast our future revenues or operating results. There can be no assurance that the expected revenues or profits will be fully derived
from such arrangements.

Our Success Depends on Our Ability to Protect Our Proprietary Technology.

Risks Relating to Intellectual Property

Our industry places considerable importance on obtaining patent, trademark and trade secret protection, as well as other intellectual
property rights, for new technologies, products and processes. Our success depends, in part, on our ability to develop and maintain a
strong intellectual property portfolio or obtain licenses to patents and technologies, both in the United States and in other countries. If
we cannot continue to develop, obtain and protect intellectual property rights, our revenues and profits could be adversely affected.
Moreover, our current and future licenses or other rights to patents and other technologies may not be adequate for the operation of our
business.

As appropriate, we intend to file patent applications and obtain patent protection for our proprietary technology. These patent
applications and patents will cover, as applicable, compositions of matter for our products, methods of making those products, methods
of using those products and apparatuses relating to the use or manufacture of those products.

We also rely on trade secrets, know-how and continuing technological advancements to protect our proprietary technology. We have
entered, and will continue to enter, into confidentiality agreements with our employees, consultants, advisors and collaborators. Our
employees and third-party consultants also sign agreements requiring that they assign to us interests in inventions and original
expressions and any patents or copyrights arising from their work. However, these parties may not honor these agreements.

We cannot guarantee that the process of filing patents, the laws governing trade secrets and proprietary information, or any agreements
we enter into with employees, consultants, advisors or collaborators will provide adequate protection of our intellectual property rights.
For example, our competitors may develop similar products without infringing on any of our intellectual property rights or design around
our proprietary technologies. Employees, consultants and others who participate in the development of our products may breach their
agreements with us regarding our intellectual property, and we may not have adequate remedies for the breach. We also may not be able
to effectively protect our intellectual property rights in some foreign countries, as many countries do not offer the same level of legal
protection for intellectual property as the United States.

For a variety of reasons, we may decide not to file for patent, copyright or trademark protection outside of the U.S. Our trade secrets
could become known through other unforeseen means. Although we have licensed certain technology for use in our microbiome
laboratory services offerings and we have developed proprietary know-how that we use in this business, we do not currently hold any
patents covering the laboratory processes and analytical methods offered to our customers. The absence of patent protection in this or
other parts of our business may make it more difficult to protect our intellectual property. In addition, our competitors may independently
develop similar or alternative technologies or products that are equal or superior to our technology.

Moreover, issued patents remain in effect for a fixed period and after expiration will not provide protection of the inventions they cover.
Once our patents expire, we may be faced with increased competition, which could reduce our revenues. We may also not be able to
successfully protect our rights to unpatented trade secrets and know-how.

Some of our employees, including scientific and management personnel, were previously employed by competing companies. Although
we encourage and expect all of our employees to abide by any confidentiality agreement with a prior employer, competing companies
may allege trade secret violations and similar claims against us. In addition, some of these agreements may conflict with, or be subject
to, the rights of third parties with whom our employees, consultants or advisers have prior employment or consulting relationships. An
adverse determination may limit or restrict the type of work that certain employees involved with such products may perform.

We may collaborate with universities and governmental research organizations or receive funding for our products from government
agencies. As a result, one or more of these entities may acquire part of the rights to any inventions or technical information derived
from our collaboration or funding relationship with them.

To facilitate development and commercialization of a proprietary technology base, we may need to obtain licenses to patents or other
proprietary rights from other parties. Obtaining and maintaining such licenses may require the payment of substantial amounts. In
addition, if we are unable to obtain these types of licenses, our product development and commercialization efforts may be delayed or
precluded. Moreover, some licenses may be nonexclusive, and therefore our competitors may have access to the same technology
licensed to us.

We May Become Involved in Intellectual Property Disputes, Which Could Increase our Costs and Limit or Eliminate Our Ability
to Sell Products, Provide Services or Use Certain Technologies.

From time to time, we may seek to enforce our patents or other intellectual property rights through litigation. In addition, there are a
large number of patents and patent applications in our product and service areas, and additional patents may be issued to third parties
relating to our product and service areas. We, our customers or our suppliers may be sued for infringement of patents or misappropriation
of other intellectual property rights with respect to one or more of our products or services. Litigation in our industry regarding patent
and other intellectual property rights is prevalent and is expected to continue. We may also have disputes with parties that license patents
to us if we believe the license is no longer needed for our products or services or the licensed patents are no longer valid or enforceable.

Our industry is characterized by a large number of patents, and the claims of these patents appear to overlap in many cases. As a result,
there is a significant amount of uncertainty regarding the extent of patent protection and infringement. Companies may have pending
patent applications, which are typically confidential for the first eighteen months following filing, that cover technologies we incorporate
in our products or services. Accordingly, we may be subjected to substantial damages for past infringement or be required to modify

our products or services or stop selling them if it is ultimately determined that our products or services infringe a third party’s proprietary
rights. In addition, governmental agencies could commence investigations or criminal proceedings against our employees or us relating
to claims of misuse or misappropriation of another party’s proprietary rights.

Intellectual property litigation is costly. As such, our involvement in litigation or other legal proceedings with respect to patents or other
intellectual property and proprietary technology, either as a plaintiff or defendant, could adversely affect our revenues, market share,
results of operations and business because:

•

It could consume a substantial portion of managerial and financial resources;

Its outcome would be uncertain and a court may find that our patents are invalid or unenforceable in response to claims by
another party or that the third-party patent claims are valid and infringed by our products or services;

An adverse outcome could subject us to the loss of the protection of our patents or to liability in the form of past royalty
payments, penalties, reimbursement of litigation costs and legal fees, special and punitive damages, or future royalty
payments, any of which could significantly affect our future earnings;

Governmental agencies may commence investigations or criminal proceedings against our employees, former employees
and us relating to claims of misappropriation or misuse of another party’s proprietary rights;

Failure to obtain a necessary license upon an adverse outcome could prevent us from selling our current products or services
or other products or services we may develop or acquire;

We may be required to alter our product or services, given the proprietary rights of others;

The pendency of any litigation may in and of itself cause our distributors and customers to reduce or terminate purchases
of our products or services; and

A court could award a preliminary and/or permanent injunction, which would prevent us from selling our current or future
products or services.

We may indemnify some customers and strategic partners under our agreements with such parties if our products, services or activities
have actually or allegedly infringed upon, misappropriated or misused another party’s proprietary rights. Further, our products or
services may contain technology provided to us by other parties, such as universities, contractors, suppliers, customers or collaborators,
and we may have little or no ability to determine in advance whether such technology infringes the intellectual property rights of a third
party. These other parties may also not be required or financially able to indemnify us in the event that an infringement or
misappropriation claim is asserted against us.

We may also become involved in other types of disputes regarding intellectual property rights, including state, federal or foreign court
litigation, and patent interference, patent reexamination, patent reissue, or trademark opposition proceedings in the United States Patent
and Trademark Office. Opposition or revocation proceedings could be instituted in a foreign patent office as well. Under Federal law,
various forms of post issuance patent review proceedings have been authorized, including an inter-parties review process. These
proceedings permit certain persons to challenge the validity of a patent on the grounds that it was known from the prior art. The filing
of such proceedings, or the issuance of an adverse decision in such proceedings, could result in the loss of valuable patent rights that
could have a material adverse effect on our business, financial condition, results of operations and growth prospects.

Regulatory Risks

The Need to Obtain Regulatory Approvals, Clearances, Authorizations or Certifications Could Increase Our Costs and
Adversely Affect Our Financial Performance.

Many of our proposed and existing products and services are subject to regulation by the FDA and other governmental or public health
agencies. In particular, we are subject to strict governmental controls on the development, manufacture, labeling, distribution and
marketing of our products and the processes and procedure for our laboratory services. Our practice is to train our employees on the
legal requirements applicable to our business, including the requirements of the FDA and other relevant agencies.

The process of obtaining required approvals, clearances, other premarket authorizations or certifications can involve lengthy and detailed
laboratory testing, human clinical trials, sampling activities and other costly, time-consuming procedures. These approvals, clearances,
other premarket authorizations or certifications can require the submission of a large amount of clinical data which can be expensive
and may require significant time to obtain. It is also possible that a product will not perform at a level needed to generate the clinical
data required to obtain such premarket authorizations or certifications. The submission of an application to the FDA or other regulatory
authority does not guarantee that an authorization to market or import the product or a laboratory certification will be received. A

regulatory authority may impose requirements as a condition to granting an approval, clearance, premarket authorization or certification
that may include significant restrictions or limitations. The regulatory authority may delay or refuse to grant premarket authorization or
certification, even though a product has been approved or registered without restrictions or limitations in another country or by another
agency. Delays in receipt or failure to receive such approvals, clearances, premarket authorization or certification could have a material
adverse effect on our business, financial condition and results of operations.

All in vitro diagnostic products that are to be sold in the EU must bear the CE mark indicating conformance with the requirements of
the relevant EU in vitro diagnostic medical devices legislation. The new EU Regulation 2017/746 on in vitro diagnostic medical devices
("IVDR"), became applicable on May 26, 2022 and repealed the previous Directive 98/79/EC, ("IVDD"). There is a transitional period
during which products that have a declaration of conformity issued under the IVDD prior to May 26, 2022 may continue to be placed
on the EU market for a certain period before requiring certification under the IVDR; however, class A non-sterile products do not benefit
from such transitional provisions and have been required to be IVDR compliant since May 26, 2022. We have obtained the CE mark for
several of our existing products [under the IVDD]. We also intend to apply for CE marks for certain of our future products and are not
aware of any material reason why we would be unable to obtain those marks. However, there can be no assurance that compliance with
all provisions of the IVDR will be demonstrated and the CE mark will be obtained or maintained for all products that we desire to sell
in the EU. The failure to obtain or maintain the CE mark for one or more of our products could lead to the termination of strategic
alliances and agreements for sales of those products in the EU and mean that we are unable to sell such products in the EU.

In addition, we or our distributors are often required to obtain premarket authorization or product registration with foreign governments
or regulatory bodies before we can import and sell our products in foreign countries. We may also be required to obtain WHO pre-
qualification or endorsement in order to sell certain products in international markets or enable our customers to access interested funding
sources for our products. We may have difficulty obtaining such authorizations, registrations, pre-qualifications or endorsements and,
if obtained, such authorizations, registrations, pre-qualifications or endorsements may contain restrictions that limit our ability to market
and sell our products in the relevant country. In addition, any change in our arrangement with a foreign distributor could result in the
loss of or delay in transfer of any applicable product registrations, thereby interrupting our ability to sell those products in the affected
markets.

Failure to Comply With FDA or Other Regulatory Requirements May Require Us to Suspend Production or Sale of Our
Products or Institute a Recall Which Could Result in Higher Costs and a Loss of Revenues.

Regulation by the FDA and other federal, state and foreign regulatory agencies impacts many aspects of our operations, and the
operations of our suppliers and distributors, including manufacturing, labeling, packaging, adverse event reporting, recalls, distribution,
storage, advertising, promotion and recordkeeping. We are subject to routine inspection by the FDA and other agencies to determine
compliance with QSR and FDA regulatory requirements in the United States and other applicable regulations worldwide, including but
not limited to ISO standards. We believe that our facilities and procedures are in material compliance with the FDA requirements and
ISO standards, but the regulations may be unclear and are subject to change, and we cannot be sure that the FDA or other regulators will
agree with our compliance with these requirements. The FDA and foreign regulatory agencies may require post-marketing testing and
surveillance to monitor the performance of approved or cleared products or impose conditions on any product clearances or approvals
that could restrict the distribution or commercial applications of those products. Regulatory agencies may impose restrictions on our or
our distributors’ advertising and promotional activities or preclude these activities altogether if a noncompliance is believed to exist. In
addition, the subsequent discovery of previously unknown problems with a product may result in restrictions on the product or additional
regulatory actions, including withdrawal of the product from the market.

Failure to comply with the applicable requirements of the FDA can result in, among other things, 483 notices, warning letters,
administrative or judicially imposed sanctions such as injunctions, civil penalties, recall or seizure of products, total or partial suspension
of production, refusal to grant PMA approval for devices, withdrawal of product registrations, marketing clearances or approvals, or
criminal prosecution. The ability of our suppliers to supply critical components or materials and of our distributors to sell our products
could also be adversely affected if their operations are determined to be out of compliance. Such actions by the FDA and other regulatory
bodies could adversely affect our revenues, costs and results of operations.

Some of our products, particularly those sold by DNAG, are sold for research purposes in the U.S. We do not promote these products
for clinical diagnostic use and they are labeled “For Research Use Only” ("RUO"). If the FDA were to disagree with our RUO
designation of a product, we could be forced to recall and/or stop selling the product until appropriate regulatory clearance or approval
has been obtained.

In the ordinary course of business, we must frequently make subjective judgments with respect to compliance with applicable laws and
regulations. If regulators subsequently disagree with the manner in which we have sought to comply with these regulations, we could
be subjected to substantial civil and criminal penalties, as well as product recall, seizure or injunction with respect to the sale of our

products. The assessment of any civil and criminal penalties against us could severely impair our reputation within the industry and any
limitation on our ability to manufacture and market our products could have a material adverse effect on our business.

Our Inability to Respond to Changes in Regulatory Requirements Could Adversely Affect Our Business.

We believe that our products and procedures are in material compliance with all applicable FDA regulations, ISO requirements, and
other applicable regulatory requirements, but the regulations regarding the manufacture and sale of our products, the QSR and ISO
requirements, and other requirements may be unclear and are subject to change. Newly promulgated regulations could require changes
to our products, necessitate additional clinical trials or procedures, or make it impractical or impossible for us to market our products
for certain uses, in certain markets, or at all. The FDA and other regulatory authorities also have the ability to change the requirements
for obtaining product approval or clearance and/or impose new or additional requirements as part of the approval or clearance process.
These changes or new or additional requirements may occur after the completion of substantial clinical work and other costly
development activities. The implementation of such changes or new or additional requirements may result in additional clinical trials
and substantial additional costs and could delay or make it more difficult or complicated to obtain approvals and sell our products. We
cannot predict the effect, if any, that these changes might have on our business, financial condition or results of operations.

We Are Subject to Numerous Government Regulations in Addition to FDA Requirements, Which Could Increase Our Costs
and Affect Our Operations.

In addition to the FDA and other regulations described previously, laws and regulations in some states may restrict our ability to sell
products in those states. While we intend to work with state legislators and regulators to remove or modify any applicable restrictions,
there is no guarantee we will be successful in these efforts.

We must also comply with numerous laws relating to such matters as safe working conditions, manufacturing practices, environmental
protection, fire hazard control, disposal of hazardous substances, labor or employment practices and the configuration and operation of
the websites through which we advertise our products. As a device manufacturer, we are required to report annually to the Centers for
Medicare & Medicaid Services (“CMS”) any payments or transfers of value we have made to physicians and teaching hospitals and any
physician ownership or investment interest in our business. In the U.S., before we can market a new medical device, or a new use of,
or claim for, or significant modification to, an existing product, we generally must first receive either 510(k) clearance or de novo
authorization or approval of a PMA from the FDA. Similarly, most major markets for medical devices outside the U.S. also require
clearance, approval, authorization or compliance with certain standards before a product can be commercially marketed. Compliance
with these laws or any new or changed laws regulating our business could result in substantial costs. Because of the number and extent
of the laws and regulations affecting our industry, and the number of governmental agencies whose actions could affect our operations,
it is impossible to reliably predict the full nature and impact of these requirements. To the extent the costs and procedures associated
with complying with these laws and requirements are substantial or it is determined that we do not comply, our business and results of
operations could be adversely affected.

Failure to Comply With Privacy, Security and Breach Notification Regulations May Increase Our Costs.

In the past, the Health Insurance Portability and Accountability Act of 1996, as amended (“HIPAA”) has generally affected us indirectly,
as we are generally neither a Covered Entity nor a Business Associate, as further defined under HIPAA, to Covered Entities. We have
in place certain administrative, technical and physical safeguards to protect the privacy and security of consumers’ personal information
and endeavors to comply with all applicable state and federal laws with respect to the protection of consumers’ personal information.
We are required to comply with varying state privacy, security and breach reporting laws. If we do not comply with existing or new
laws and regulations related to properly transferring data containing consumers’ personal information, we could be subject to monetary
fines, civil penalties or criminal sanctions. In addition to other federal and state laws that protect the privacy and security of consumers’
personal information, we may be subject to enforcement and interpretations by various governmental authorities and courts resulting in
complex compliance issues. Moreover, the potential for enforcement action against us is now greater, as the U.S. Department of Health
and Human Services (HHS) can take action directly against Business Associates. Thus, while we believe we are and will be in
compliance with all required HIPAA standards, there is no guarantee that the government will agree. Enforcement actions can be costly
and interrupt regular operations of our business. For example, we could incur damages under state laws pursuant to an action brought
by a private party for the wrongful use or disclosure of consumers’ personal information.

Failure to Comply With Data Protection Requirements or Privacy Laws Could Increase Our Costs.

The EU has adopted a comprehensive overhaul of its data protection regime from the prior national legislative approach to a single
European Economic Area Privacy Regulation called the General Data Protection Regulation (“GDPR”), which came into effect on May
25, 2018. The new EU data protection regime extends the scope of the EU data protection law to all foreign companies processing data
of EU residents. It provides for a harmonization of the data protection regulations throughout the EU, thereby making it easier for non-

European companies to comply with these regulations. It imposes a strict data protection compliance regime with severe penalties of
up to the greater of 4% of worldwide turnover and €20 million and includes new rights such as the “portability” of personal data.
Although the GDPR will apply across the EU without a need for local implementing legislation, as had been the case under the prior
data protection regime, local data protection authorities will still have the ability to interpret the GDPR, which has the potential to create
inconsistencies on a country-by-country basis. We are implementing a plan to ensure compliance with these new requirements.
Complying with the enhanced obligations imposed by the GDPR may result in significant costs to our business and require us to amend
certain of our business practices. Further, we have no assurances that violations will not occur, particularly given the complexity of the
GDPR, as well as the uncertainties that accompany new, comprehensive legislation.

We are also subject to the California Consumer Privacy Act of 2018 (“CCPA”), which took effect on January 1, 2020. The CCPA
imposes extensive new requirements and protections on the processing of personal data, aimed at giving California consumers more
visibility and control over their personal information. Failure to comply with the CCPA or other data processing or security laws, or
any changes in these laws, could adversely impact our business and our business plans. In 2020, the California residents voted the
California Privacy Rights Act (the "CPRA") into law. The CPRA will impose additional data protection obligations on covered
businesses, including additional consumer rights processes, limitations on data uses, new audit requirements for higher risk data, and
opt outs for certain uses of sensitive data. The CPRA also created a new California data protection agency authorized to issue substantive
regulations and could result in increased privacy and information security enforcement. The majority of the CPRA provisions became
effective on January 1, 2023, and additional compliance investment and potential business process changes may be required. Similar
laws have been proposed, and likely will be proposed, in other states and at the federal level, and if passed, such laws may have
potentially conflicting requirements that would make compliance challenging.

FDA Regulation of Laboratory-Developed Tests and Genetic Testing Could Affect Demand For Our Products.

The FDA has regulatory responsibility over instruments, test kits, reagents and other devices used to perform diagnostic testing by
clinical laboratories. In the past, the FDA has taken the position that it has regulatory authority over laboratory-developed tests ("LDTs"),
but has exercised enforcement discretion in not regulating most LDTs performed by high complexity CLIA-certified laboratories. LDTs
are tests designed, developed, and performed in-house by a laboratory. Such laboratories are subject to regulation under CLIA but have
not been subject to regulation by the FDA under the agency’s medical device requirements. A significant portion of the total volume of
genetic or molecular testing is performed with LDTs.

In mid-2010, the FDA announced that it would begin regulating LDTs, including laboratory developed molecular tests, and in October
2014 issued proposed guidance on the regulation of LDTs for public comment. On January 13, 2017, the FDA released a discussion
paper synthesizing public comments on the 2014 draft guidance documents and outlining a possible approach to regulation of LDTs.
The discussion paper has no legal status and does not represent a final version of the LDT draft guidance documents. We cannot predict
what policies will be adopted with respect to regulating LDTs. FDA has been working with regulatory advocacy groups to bring forward
legislative approaches specifically for in vitro diagnostic tests including LDTs. For example, in 2021, the Verifying Accurate, Leading-
edge, IVCT Development ("VALID") Act was introduced to Congress and provided a framework to change IVDs and LDTs to in vitro
clinical tests ("IVCTs"). The proposed regulation would give FDA oversight of LDTs once it becomes law. In 2022, the VALID Act
was incorporated into the Senate user fee bill but was not included in the year-end Consolidated Appropriations Act of 2022. Absent
congressional legislation to clarify FDA's authorities, the FDA may consider administrative action, such as rule making, to clarify
requirements for LDT's.

Our subsidiary, DNAG, sells its DNA collection systems to certain laboratories and other customers for use with LDTs. The FDA’s
increased regulation of LDTs could make it more difficult for laboratories and other customers to continue offering LDTs that involve
genetic or molecular testing. This, in turn, could increase costs, delay the introduction of new LDTs and reduce demand for DNAG’s
products and adversely impact our revenues.

In 2019, the Department of Justice indicted a number of telemedicine companies and cancer genetic testing laboratories for allegedly
submitting fraudulent insurance claims to Medicare. A number of these companies were customers of DNAG. As a result of these
activities, the FDA has issued letters to genetic testing laboratories indicating that it plans to increase oversight of this market which has
caused some of these companies to stop providing testing options or to change how they are reporting the information provided by the
testing. The activities have negatively affected this market and there is a risk that these enforcement actions will continue to negatively
affect this market by forcing laboratories to either stop offering such services or restricting the use of such services. Such a reduction
in testing could result in decreased sales of our DNA collection devices.

Our International Sales Create Potential Exposure Under Anti-Corruption Laws.

We have a policy in place prohibiting our employees, distributors and agents from engaging in corrupt business practices, including
activities prohibited by the FCPA and similar foreign laws. In 2022, approximately $37.3 million of our consolidated net revenues were

generated from sales in a variety of foreign countries. These international activities subject us to the FCPA, the U.K. Bribery Act and
other laws that prohibit improper payments or offers of payments to foreign governments and their officials and political parties by
business entities for the purpose of obtaining or retaining business. We have operations, enter into agreements with third parties, and
make sales in countries known to experience corruption. Further international expansion, including the acquisition of foreign entities,
may create increased exposure to such practices. Our activities in these countries create the risk of unauthorized payments or offers of
payments by one of our employees, consultants, sales agents or distributors that could be in violation of various laws, including the
FCPA, even though these parties are not always subject to our control. It is our policy to implement safeguards to discourage these
practices by our employees and distributors, including employee training, contracts requiring compliance with the FCPA and similar
rules, and standard reviews of our distributors. However, our existing safeguards and any future improvements may not prove to be
effective, and our employees, consultants, sales agents or distributors may engage in conduct for which we might be held responsible.
Violations of the FCPA and other laws may result in criminal or civil sanctions, which could be severe and we may be subject to other
liabilities, which could negatively affect our reputation, business, results of operations and financial condition.

Risks Relating to the Economy, Our Financial Results, Investments, Credit Facilities and Need for Financing

We Have Experienced Losses in the Past and May Not Be Able To Again Achieve and Maintain Profitable Operations.

We experienced annual net losses during the five years prior to 2015 and again in 2020, 2021 and 2022. In addition, as of December
31, 2022, we had an accumulated deficit of $138.4 million. Even though we achieved profitability in 2015 through 2019, there can be
no assurance that we will be able to achieve or sustain profitability in the future.

Our ability to achieve and continue profitable operations in the future will be dependent upon a number of factors including, without
limitation, the following:

•

Our ability to continue growing sales of our molecular collection products and related genomic and microbiome laboratory
services;

Our ability to produce and successfully commercialize our InteliSwab® COVID-19 Rapid Tests and compete with
comparable products;

Our ability to grow our OraQuick ADVANCE® HIV 1/2 test in the United States and expand sales of our OraQuick® HIV
Self-Test internationally;

Changes in the markets in which we operate, including changes in the prevalence of COVID-19;

Changes in customer buying patterns or a buildup of significant quantities in our distributors’ inventories or distribution
channels;

The level of expenditures we are required to make in order to develop, obtain regulatory approvals for and successfully
commercialize our new products;

Our ability to expand our business through the acquisition of other companies or technologies or through internal
development of new or improved products;

Our ability to improve manufacturing efficiencies and reduce cost of goods sold;

Our ability to successfully launch new products after receipt of required regulatory approvals or the acquisition of rights to
those products;

The degree to which our major distributors and customers comply with their contractual obligations, including minimum
purchase commitments;

Whether we are successful in obtaining and maintaining required regulatory approvals and registrations for our new
products;

The level of competition, including the degree to which competitors sell lower priced products or more attractive offerings
to compete with our products;

Changes in economic conditions in domestic or international markets, such as economic downturns, reduced demand,
inflation and currency fluctuations;

Failure to achieve our revenue growth targets; and

The costs and results of patent infringement, product liability and other litigation or claims asserted by or against us.

We began a strategic restructuring of our business in early 2023 by combining our Molecular Solutions and Diagnostics business units
into a single commercial organization, and eliminated approximately 11% of our non-production workforce. While we believe this
strategic restructuring will result in new efficiencies and a decrease in expenses, there can be no assurance that we will achieve such
operational efficiencies, and our consolidated financial results may be adversely impacted as a result.

Recent Volatility In Capital Markets And Lower Market Prices For Our Securities May Affect Our Ability To Access New
Capital Through Sales Of Shares Of Our Common Stock Or Issuance Of Indebtedness, Which May Materially Harm Our
Liquidity, Limit Our Ability To Grow Our Business, Pursue Acquisitions Or Improve Our Operating Infrastructure And
Restrict Our Ability To Compete In Our Markets.

Our operations consume substantial amounts of cash, and we intend to continue to make significant investments to support our business
growth, respond to business challenges or opportunities, develop new solutions, retain or expand our current levels of personnel, improve
our existing solutions, enhance our operating infrastructure, and potentially acquire complementary businesses and technologies. Our
future capital requirements may be significantly different from our current estimates and will depend on many factors, including the
need to:

•

finance unanticipated working capital requirements;

develop or enhance our technological infrastructure and our existing solutions;

pursue acquisitions or other strategic relationships; and

respond to competitive pressures.

Accordingly, we may need to pursue equity or debt financing to meet our capital needs. With uncertainty in the capital markets and
other factors, such financing may not be available on terms favorable to us or at all. If we raise additional funds through further issuances
of equity or convertible debt securities, our existing stockholders could suffer significant dilution, and any new equity securities we
issue could have rights, preferences, and privileges superior to those of holders of our common stock. Any debt financing secured by us
in the future could involve additional restrictive covenants relating to our capital-raising activities and other financial and operational
matters, which may make it more difficult for us to obtain additional capital and to pursue business opportunities, including potential
acquisitions. If we are unable to obtain adequate financing or financing on terms satisfactory to us, we could face significant limitations
on our ability to invest in our operations and otherwise suffer harm to our business.

Economic Volatility and Disruption, Including Those Related To The COVID-19 Pandemic, Could Adversely Affect Our
Business, Financial Performance, Results of Operations, Cash Flow and Financial Condition or Those of Our Customers and
Suppliers.

Global and U.S. markets and economies have experienced extreme volatility and disruption following the global outbreak of COVID-
19 that has continued throughout 2022. Many economists and major investment banks have expressed concern that the continued spread
of the virus globally has led to a world-wide economic downturn. Volatile economic conditions may occur again or continue in the
future.

Although the severity and duration of the COVID-19 pandemic cannot be reasonably estimated at this time, impacts that we may
experience include, but are not limited to:

•

a slowdown or stoppage in the supply chain of the raw materials and components used to manufacture our products;

interruptions or delays in domestic and/or international shipment of our products to our distributors and customers;

interruptions in normal operations of certain end-use customers that could result in reductions in demand for our products;

disruptions to our operations, including a shutdown of our facilities or product lines; restrictions on our operations and sales,
marketing and distribution efforts; and interruptions to our research and development, manufacturing, clinical/regulatory
and other important business activities;

shutdown or interruption of our manufacturing facilities due to contamination and costs incurred to clean and disinfect a
facility following contamination;

inefficiencies and increased costs in our production and shipping processes due to premium pay for manufacturing and
certain other employees as well as social distancing and personal protective equipment requirements;

limitations on employee resources and availability, including due to sickness, government restrictions, the desire of
employees to avoid contact with large groups of people or mass transit disruptions;

•

a fluctuation in foreign currency exchange rates or interest rates could result from market uncertainties;

an increase in exposure to credit losses for customers adversely affected by the COVID-19 pandemic; and

an increase in regulatory restrictions or continued market volatility could hinder our ability to execute strategic business
activities, including acquisitions.

These conditions could adversely affect our financial performance and condition or those of our customers and suppliers. These
circumstances could also adversely affect our access to liquidity needed to conduct or expand our business or conduct future acquisitions
or make other discretionary investments. Many of our customers rely on public funding provided by federal, state and local governments,
and this funding has been and may continue to be reduced or deferred as a result of economic conditions or other factors. These
circumstances may adversely impact our customers and suppliers, which, in turn, could adversely affect their ability to purchase and/or
distribute our products or supply us with necessary equipment, raw materials or components. Any or all of these effects would have an
adverse effect on our operations, business, financial condition and results of operations.

Although there are positive signs that COVID-19 has begun to subside as compared to the height of the pandemic, the duration of the
COVID-19 pandemic is still unknown, and it is difficult to predict the full extent of potential impacts the pandemic will have in the
future on our business, operations, and financial results, or on our customers, suppliers or logistics providers, or on the global economy
as a whole. It is uncertain how materially the COVID-19 pandemic will affect our global operations, particularly if the effects continue
or get worse over an extended period of time. Even with the improvement of economic conditions, it may take time for our customers
and suppliers to establish new budgets and return to normal purchasing and shipping patterns. We cannot predict the re-occurrence of
any economic slowdown or the strength or sustainability of an economic recovery.

Rising Inflation Rates Could Negatively Impact Our Revenues And Profitability If Increases In The Prices Of Our Products
Or A Decrease In Consumer Spending Results In Lower Sales. In Addition, If Our Costs Increase And We Are Not Able To
Pass Along These Price Increases To Our Customers, Our Net Income Would Be Adversely Affected, And The Adverse
Impact May Be Material.

Inflation rates, particularly in the United States, have increased recently to levels not seen in years. Increased inflation may result in
decreased demand for our products and services, increased operating costs (including our labor costs), reduced liquidity, and limitations
on our ability to access credit or otherwise raise debt and equity capital. In addition, the United States Federal Reserve has raised, and
may again raise, interest rates in response to concerns about inflation. Increases in interest rates, especially if coupled with reduced
government spending and volatility in financial markets, may have the effect of further increasing economic uncertainty and heightening
these risks. In an inflationary environment, we may be unable to raise the sales prices of our products at or above the rate at which our
costs increase, which could/would reduce our profit margins and have a material adverse effect on our financial results and net income.
We also may experience lower than expected sales and potential adverse impacts on our competitive position if there is a decrease in
consumer spending or a negative reaction to our pricing. A reduction in our revenue would be detrimental to our profitability and
financial condition and could also have an adverse impact on our future growth.

An Impairment of Goodwill and Intangible Assets Could Reduce our Earnings.

At December 31, 2022, our consolidated balance sheet reflected approximately $35.1 million of goodwill and approximately $11.7
million of intangible assets. Goodwill is recorded when the purchase price of a business exceeds the fair value of the tangible and
separately measurable intangible net assets. U.S. generally accepted accounting principles (“U.S. GAAP”) require us to test goodwill
for impairment on an annual basis or when events or circumstances occur indicating that goodwill might be impaired. Long-lived assets,
such as intangible assets with finite useful lives, are reviewed for impairment whenever events or changes in circumstances indicate that
the carrying amount may not be recoverable. The impairment review often cannot be done at the level of the individual asset and it
must instead be applied to a group of assets. For the purpose of our annual goodwill impairment testing based on the current
circumstances of how we manage or business, this group of assets is the Company as a whole. If we determine that any of our goodwill
or intangible assets were impaired, we will be required to take an immediate charge to earnings and our results of operations could be
adversely affected. We recognized a pre-tax impairment charge of $3.6 million during the year ended December 31, 2022, which is
reported in loss on impairments in our consolidated statement of operations.

Changes in Foreign Currency Exchange Rates Could Negatively Affect Our Operating Results.

Our financial statements are stated in U.S. Dollars and, historically, most of our international sales have also been denominated in U.S.
Dollars. As a result, in the past our exposure to foreign currency exchange rate risk has not been material. Nonetheless, these sales are
subject to currency risks since changes in the values of foreign currencies relative to the value of the U.S. dollar can render our products
comparatively more expensive. These exchange rate fluctuations could negatively impact international sales of our products, as could
changes in the general economic conditions in those markets.

In addition, the revenues and expenses of our subsidiary, DNAG, are recorded in Canadian Dollars and the revenues and expenses of
our subsidiary Novosanis are recorded in Euros. Revenues and expenses denominated in foreign currencies are translated into U.S.
dollars for purposes of reporting our consolidated financial results. Our expectation is that the businesses of our foreign subsidiaries will
continue to grow and our exposure to foreign currency exchange rates may be more significant than in past years.

Exchange rate fluctuations may affect the revenues and expenses of our foreign subsidiaries and the translation of those financial results
into U.S. dollars. Favorable movement in exchange rates have benefited us in prior periods. However, where there are unfavorable
currency exchange rate fluctuations, our consolidated financial statements including our balance sheet, revenues and results of
operations, could be negatively affected. In addition, fluctuations in exchange rates could affect year-to-year comparability of operating
results. In the past, we have not generally entered into hedging instruments to manage our currency exchange rate risk, but we may need
to do so in the future. However, our attempts to hedge against these risks may not be successful. If we are unable to successfully hedge
against unfavorable foreign currency exchange rate movements, our consolidated financial results may be adversely impacted.

Our Stock Price Could Continue to be Volatile.

Risks Relating to Our Common Stock

Our stock price has been volatile, has fluctuated substantially in the past, may be volatile in the future and could experience substantial
declines. The following factors, among others, could have a significant impact on the market for our Common Stock:

•

The performance of our business, including our efforts to increase sales of our OraQuick® HIV, HCV and Molecular
Solutions products and our OraQuick® In-Home HIV test and HIV Self-Test;

Our efforts to expand sales of our genomic and microbiome laboratory service offerings;

Our efforts to produce and commercialize our InteliSwab Covid-19 Rapid Tests;

Future announcements concerning us and our products or services, including with respect to significant acquisitions,
strategic collaborations and joint ventures;

Ability to achieve the expected benefits, enhanced revenue growth and synergies from strategic acquisitions;

Clinical results with respect to our products or services or those of our competitors;

The status of clinical studies and pending submissions for required regulatory approvals;

The announcement of regulatory or enforcement actions by the FDA or other agencies against us, our products or services,
or one or more of our customers;

The gain or loss of significant contracts and availability of funding for the purchase of our products and services;

Delays in the development, regulatory approval or commercialization of new or enhanced products or services;

Legislative developments and industry or competitive trends;

Biological or medical discoveries;

Disputes or developments with key customers, distributors or suppliers;

Developments in patent or other proprietary rights;

Litigation or threatened litigation;

Complaints or concerns about the performance or safety of our products and publicity about those issues, including publicity
expressed through social media or otherwise over the internet;

Failure to achieve, or changes in, financial estimates by securities analysts and comments or opinions about us by securities
analysts or major stockholders;

Governmental regulation;

Changes in the level of competition;

Loss of or declines in sales to major distributors or customers or changes in the mix of products sold;

Period-to-period fluctuations in our operating results;

•

Additions or departures of key personnel;

General market and economic conditions; and

Terrorist attacks, civil unrest, war and national disasters, including pandemics.

In addition, the stock market in general has experienced extreme price and volume fluctuations that have affected the market price of
our Common Stock, as well as the stock of many companies in the diagnostics and life sciences industries. Often, price fluctuations are
unrelated to the operating performance of the specific companies whose stock is affected.

In the past, following periods of volatility in the market price of a company’s stock, securities class action litigation has occurred against
the issuing company. If we were subject to this type of litigation in the future, we could incur substantial costs and experience a
subsequent diversion of our management’s attention and resources, each of which could have a material adverse effect on our revenue
and earnings. Any adverse determination in this type of litigation could also subject us to significant liabilities.

Future Sales of Our Common Stock by Existing Stockholders, Executive Officers or Directors Could Depress the Market Price
of Our Common Stock and Make It More Difficult For Us to Sell Stock in the Future.

Sales of our Common Stock in the public market, or the perception that such sales may occur, could negatively impact the market price
of our Common Stock. We are unable to estimate the number of shares of our Common Stock that may actually be resold in the public
market since this will depend on the market price for our Common Stock, the individual circumstances of the sellers and other factors.

We have a number of institutional stockholders that own significant blocks of our Common Stock. If one or more of these stockholders
sell large portions of their holdings in a relatively short time, for liquidity or other reasons, the prevailing market price of our Common
Stock could be negatively affected. In addition, it is possible that one or more of our executive officers or non-employee members of
our Board of Directors could sell shares of our Common Stock during an open trading window or pursuant to a 10b5-1 sales plan under
our Insider Trading Policy. These transactions and the perceived reasons for these transactions could have a negative effect on the
prevailing market price of our Common Stock.

Because We Do Not Intend to Pay Cash Dividends on Our Common Stock, an Investor in Our Common Stock Will Benefit Only
if Our Common Stock Appreciates in Value.

We currently intend to retain our current earnings and future earnings, if any, to finance the expansion of our business and do not expect
to pay any cash dividends on our Common Stock in the foreseeable future. As a result, the success of an investment in our Common
Stock will depend entirely upon any future appreciation. There is no guarantee that our Common Stock will appreciate in value or even
maintain the price at which investors purchased their shares.

Certain Provisions in Our Certificate of Incorporation and Bylaws and Under Delaware Law Could Make a Third-Party
Acquisition of Us Difficult.

Our Certificate of Incorporation and Bylaws contain provisions that could make it more difficult for a third party to acquire us, even if
doing so would be beneficial to our stockholders. We are also subject to certain provisions of Delaware law that could delay, deter or
prevent a change in control of us. These provisions could limit the price investors might be willing to pay in the future for shares of our
Common Stock.

We May Face Product Liability Claims for Injuries Resulting From the Use of Our Products.

General Risk Factors

We may be held liable if any of our products, or any product which is made with the use or incorporation of any of our technologies,
causes injury of any type or is found otherwise unsuitable during product testing, manufacturing, marketing, sale or usage. There is no
assurance that we would be successful in defending any product liability lawsuits brought against us. Moreover, there is no assurance
that our products will not be included in unethical, illegal or inappropriate research or applications, which may in turn put us at risk of
litigation. Regardless of merit or eventual outcome, product liability claims could result in:

•

Decreased demand for our products;

Lost revenues;

Damage to our image or reputation;

•

Costs related to litigation;

Increased product liability insurance costs;

Diversion of management time and attention; and

Incurrence of damages payable to plaintiffs.

We are selling the InteliSwab® COVID-19 Rapid Test and the OraQuick® In-Home HIV test in the United States OTC market, and we
offer HIV Self-Tests to consumers internationally. We believe the sale of products for use by consumers increases our potential exposure
to product liability and other claims.

Performance of Our Products May Affect Our Revenues, Stock Price and Reputation.

Our products are generally sold with labeling that contains performance claims approved or cleared by the FDA or other regulators.
However, our products may not perform as expected. For example, a defect in one of our diagnostic or specimen collection products or
a failure by a customer to follow proper testing procedures, may cause the product to report inaccurate information such as a false
positive result or a false negative result. A false positive or negative result can also occur even when there is no apparent product defect
and the customer has apparently used our product properly. Identifying the root cause of a product performance or quality issue can be
difficult and time consuming.

If our products fail to perform in accordance with the applicable label claims or otherwise in accordance with the expectations or needs
of our customers, customers may switch to a competing product or otherwise stop using our products, and our revenues could be
adversely affected. Under such circumstances, we may be required to implement shipment holds or product recalls and incur warranty
obligations, which would increase our costs. In addition, poor performance by one or more of our products and publicity surrounding
such performance could have an adverse effect on our reputation, our continuing ability to sell products and the prevailing market price
of our Common Stock.

Our Ability to Sell Products Could be Adversely Affected by Competition From New and Existing Products and Services.

The markets we serve are highly competitive and rapidly changing and we expect competition to intensify as technological advances
are made and become more widely known, and as new products and services reach the market. Many of our principal competitors have
considerably greater financial, technical and marketing resources than we do. As new products and services enter the market, our
products and services may become obsolete or a competitor’s products and services may be more effective or attractive or more
effectively marketed and sold than ours. In addition, there can be no assurance that our competitors will not succeed in obtaining
regulatory approval for new products and services that would render our technologies, products and services obsolete or otherwise
commercially unattractive, or introduce or commercialize such products and services before we can do so. If we fail to convince our
customers of the advantages and economic value of our products and services or otherwise maintain and enhance our competitive
position, our customers may decide to use products and services developed by competitors which could result in a loss of revenues.
These developments could have a material adverse effect on our business, financial condition and results of operations.

We also face competition from products that are sold at a lower price. Where this occurs, customers may choose to buy lower cost
products from third parties or we may be forced to sell our products at a lower price, both of which could result in a loss of revenues or
a lower gross margin contribution from the sale of our products. We may also be required to increase our marketing efforts in order to
compete effectively, which would increase our costs.

Failure to Achieve Our Financial and Strategic Objectives Could Have a Material Adverse Impact on Our Business Prospects.

As a result of any number of risk factors identified in this Annual Report, no assurance can be given that we will be successful in
implementing our financial and strategic objectives, including our efforts to increase sales of our products and services or continue
growing our business. In addition, the funds for research, clinical development and other projects have in the past come primarily from
our business operations. If our business slows and we have less money available to fund research and development and clinical programs,
we will have to decide at that time which programs to cut, and by how much. Similarly, if adequate financial, personnel, equipment or
other resources are not available, we may be required to delay or scale back our business. Our operations will be adversely affected if
our total revenue and gross profits do not correspondingly increase or if our technology, product, service, clinical and market
development efforts are unsuccessful or delayed. Furthermore, our failure to successfully introduce new or enhanced products and
services and develop new markets could have a material adverse effect on our business and prospects.

If We Fail To Establish and Maintain Proper And Effective Internal Control Over Financial Reporting, Our Operating Results
and Our Ability to Operate Our Business Could Be Harmed.

Ensuring that we have adequate internal financial and accounting controls and procedures in place so that we can produce accurate
financial statements on a timely basis is a costly and time-consuming effort that needs to be re-evaluated frequently. We are required to
comply with the requirements of The Sarbanes-Oxley Act of 2002, or SOX, which requires that we maintain effective internal control
over financial reporting and disclosure controls and procedures. In particular, we must perform system and process evaluation, document
our controls and perform testing of our key control over financial reporting to allow management and our independent public accounting
firm to report on the effectiveness of our internal control over financial reporting, as required by Section 404 of SOX. Our testing, or
the subsequent testing by our independent public accounting firm, may reveal deficiencies in our internal control over financial reporting
that are deemed to be material weaknesses. For instance, during the quarter ended December 31, 2022, management identified and
remediated a material weakness in internal control over financial reporting related to user access controls to adequately restrict user and
privileged access over certain information technology systems that support our financial reporting processes and to ensure appropriate
segregation of duties. While no misstatement arose as a result of this deficiency, if we are not able to comply with the requirements of
Section 404 in a timely manner, or if we or our accounting firm identify deficiencies in our internal control over financial reporting that
are deemed to be material weaknesses, the market price of our stock would likely decline and we could be subject to lawsuits, sanctions
or investigations by regulatory authorities, which would require additional financial and management resources. Additionally, any failure
to maintain the adequacy of our internal controls could prevent us from accurately reporting our financial results, which could result in
investors losing confidence in the accuracy of our financial statements and reporting systems and our stock price could decline.

If We Lose Our Key Personnel or Are Unable to Attract and Retain Qualified Personnel as Necessary, Our Business Could be
Harmed.

Our success depends to a large extent upon the contributions of our executive officers, management and sales, marketing, operations
and scientific staff. Our business may be harmed by the loss of a significant number of our executive officers or senior managers. We
may not be able to attract or retain a sufficient number of qualified employees in the future due to the intense competition for qualified
personnel among medical products, laboratory services and other life science businesses. Our ability to recruit such employees will
depend on a number of factors, including compensation, benefits, work location, the prospects of our Company, and the possibility for
advancement within our organization. We generally do not enter into employment agreements requiring our employees to work for us
for any specified period.

If we are not able to attract and retain the necessary personnel to accomplish our business objectives, we may experience constraints
that will adversely affect our ability to effectively produce, market and sell our products and services, to meet the demands of our
strategic partners in a timely fashion, or to support research, development and clinical programs. Although we believe we will be
successful in attracting and retaining qualified personnel, competition for experienced scientists and other qualified personnel from
numerous companies and academic and other research institutions may limit our ability to do so on acceptable terms.

We have recently experienced significant changes in our senior leadership, including the appointment of a new Chief Financial Officer
and Chief Product Officer, as well as a new Interim Chief Executive Officer, who was followed by a new President and Chief Executive
Officer. Although we have endeavored to implement any management and director transition in a non-disruptive manner, such
transitions might impact our business, and give rise to uncertainty among our customers, investors, vendors, employees and others
concerning our future direction and performance, which may materially and adversely affect our business, financial condition, results
of operations and cash flows, and our ability to execute our business model.

In addition, because certain members of our management and board of directors have served in their respective capacities for only
limited durations, we face the additional risks that these persons have limited familiarity with our past practices, our business and our
industry and lack established track records in managing our business strategy.

In addition, we have recently experienced turnover in other key leadership roles. Any future changes to the executive management team,
including hires or departures, could cause further disruption to the business and have a negative impact on operating performance, while
these operational areas are in transition. We can provide no assurance that we will find suitable successors to key roles as transitions
occur or that any identified successor will be successfully integrated into our management team.

If Our Essential Employees Who Are Unable To Telework Become Ill or Otherwise Incapacitated, Our Operations May Be
Adversely Impacted.

As a medical device manufacturer, we fall within a “critical essential infrastructure” sector, specifically the “Healthcare/Public Health”
sector, and are considered exempt under various stay at home/shelter in place orders. Accordingly, our employees may continue to work
because of the importance of our operations to the health and well-being of citizens in the states in which we operate. Consistent with
these Stay at Home Orders, we have implemented telework policies wherever possible for appropriate categories of “nonessential”
employees. “Essential” employees that are unable to telework continue to work at our facilities, and we have implemented appropriate

safety measures, including social distancing, face covering and increased sanitation standards. We are following guidance from the
Center for Disease Control and the Occupational Safety and Health Administration regarding suspension of nonessential travel, self-
isolation recommendations for employees returning from certain geographic areas, confirmed reports of any COVID-19 diagnosis
among our employees, and the return of such employees to our workplace. Pursuant to updated guidance from the Equal Employment
Opportunity Commission, we are engaging in limited and appropriate inquiries of employees regarding potential COVID-19 exposure,
based on the direct threat that such exposure may present to our workforce. We continue to address other unique situations that arise
among our workforce due to the COVID-19 pandemic on a case-by-case basis. While we believe that we have taken appropriate
measures to ensure the health and well-being of our “essential” employees, there can be no assurances that our measures will be sufficient
to protect our employees in our workplace or that they may otherwise be exposed to COVID-19 outside of our workplace. If a number
of our essential employees become ill, incapacitated or are otherwise unable to continue working during the current or any future
epidemic, our operations may be adversely impacted.

Increases in Demand for Our Products and Services Could Require Us to Expend Considerable Resources or Harm Our
Customer Relationships if We Are Unable to Meet That Demand.

If we experience significant or unexpected increases in the demand for our products and services, we and our suppliers may not be able
to meet that demand without expending additional capital resources. These capital resources could involve the cost of new products,
machinery or new manufacturing or laboratory facilities. This would increase our capital costs, which could adversely affect our
earnings. Our suppliers may be unable or unwilling to expend the necessary capital resources or otherwise expand their capacity. In
addition, new manufacturing or laboratory equipment and facilities may require FDA approval or government or industry certification
before they can be used to manufacture our products or provide laboratory services. To the extent we are unable to obtain or are delayed
in obtaining such approvals, our ability to meet the demand for our products and services could be adversely affected.
If we are unable to develop necessary manufacturing or laboratory capabilities in a timely manner, our sales could be adversely affected.
If we fail to increase these capabilities in a cost effective manner or if we experience lower than anticipated yields or production or
performance problems as a result of changes that we make in our manufacturing or laboratory processes to meet increased demand, we
could experience delays or interruptions and increased costs, which could also have a material adverse effect on our revenues and
profitability.

Unexpected increases in demand for our products may require us to obtain additional raw materials in order to manufacture products to
meet the demand. Some raw materials require significant ordering lead time and some are currently obtained from a sole supplier or a
limited group of suppliers. We have long-term supply agreements with certain of these suppliers, but these long-term agreements involve
risks for us, such as our potential inability to obtain an adequate supply of raw materials and components and our reduced control over
pricing, quality and timely delivery. It is also possible that one or more of these suppliers may become unwilling or unable to deliver
materials to us. Any shortfall in our supply of raw materials and components, or our inability to quickly and cost-effectively obtain
alternative sources for this supply, could have a material adverse effect on our ability to meet increased demand for our products. This
could negatively affect our total revenues or cost of sales and related profits.

Our inability to meet customer demand for our products and services could also harm our customer relationships and impair our
reputation within the industry. This, in turn, could have a material adverse effect on our business and prospects.

We Rely on Information Technology in Our Operations and Any Material Failure, Inadequacy, Interruption or Security Breach
of that Technology Could Harm Our Ability to Efficiently Operate Our Business.

We rely heavily on enterprise resource planning and other complex information technology systems across our operations and on the
internet, including for management of inventory, processing and analyzing laboratory specimens, purchase orders, invoices, shipping,
revenue and expense accounting, online business, consumer call support, and various other processes and transactions. Our ability to
effectively manage our business, coordinate the production, distribution and sale of our products, process and analyze specimens in our
laboratories, respond to customer inquiries, and ensure the timely and accurate recording and disclosure of financial information depends
significantly on the reliability and capacity of these systems and the internet.

The failure of any of the foregoing systems to operate effectively, problems with transitioning to upgraded or replacement systems, or
disruptions in the operation of the internet, could cause delays in product sales or the provision of laboratory services and reduced
efficiency of our operations. Significant expenditures could be required to remediate any such problem.

Security Breaches and Other Disruptions Could Compromise Our Information, Expose Us To Liability and Harm Our
Reputation and Business.

In the ordinary course of our business, we collect and store sensitive data, including intellectual property, personal information, our
proprietary business information and that of our customers, suppliers and business partners, and personally identifiable information of

our employees in our data centers and on our networks. Secure maintenance and transmission of this information is critical to our
operations business strategy. We generally rely on commercially available systems, software, tools and domestically available
monitoring to provide security for processing, transmitting and storing this sensitive date.

Cyber-attacks could result in unauthorized access to our computer systems or our third party IT service provider’s systems and, if
successful, misappropriate personal or confidential information. We have been victimized by a spear phishing attack, and such attacks
If successful, these activities could lead to the disclosure of intellectual property or personally identifiable
are an ongoing threat.
information, which could lead to financial harm and cause reputational damage. We have taken additional steps designed to improve
the security of our networks and computer systems.

In addition, a contractor or other third party with whom we do business may attempt to circumvent our security measures or obtain such
information, and may purposefully or inadvertently cause a breach involving sensitive information. While we will continue to evaluate
and implement additional protective measures to reduce the risk and detect cyber incidents, cyberattacks are becoming more
sophisticated and frequent and the techniques used in such attacks change rapidly. Despite our cybersecurity measures (including
employee and third party training, monitoring of networks and systems and maintenance of back up of protective systems) which are
continuously reviewed and upgraded, our information technology networks and infrastructure may still be vulnerable to damage,
disruptions or shutdowns due to attack by hackers or breaches, voyeur or malfeasance.

Even the most well protected IT networks, systems and facilities remain potentially vulnerable because the techniques used in attempted
security breaches are continually evolving and generally are not recognized until launched against a target or, in some cases, are designed
not to be detected and, in fact, may not be detected. Any such compromise of our or our third party’s IT service providers’ data security
and access, public disclosure, or loss of personal or confidential business information, could result in legal claims and proceedings,
liability under laws to protect privacy of personal information, and regulatory penalties, and could disrupt our operations, require
significant management attention and resources to remedy any damages that result, and damage our reputation and customers willingness
to transact business with us, any of which could adversely affect our business.

As our activities continue to evolve and expand, we may be subject to additional laws which impose further restrictions on the transfer,
access, use, and disclosure of health and other personal information which may impact our business either directly or indirectly. Our
failure to comply with applicable privacy or security laws or significant changes in these laws could significantly impact our business
and future business plans.

Federal and State Laws Pertaining to Healthcare Fraud and Abuse Could Adversely Affect Our Business, Financial Condition
and Results of Operations.

We are subject to various federal and state laws targeting fraud and abuse in the healthcare industry, including anti-kickback laws, false
claims laws, laws constraining the sales, marketing and promotion of medical devices by limiting the kinds of financial arrangements
that manufacturers of these products may enter into with physicians, hospitals, laboratories and other potential purchasers of medical
devices, and laws requiring the reporting of certain transactions between manufacturers and healthcare professionals. Violations of these
laws are punishable by criminal or civil sanctions, including substantial fines, imprisonment and exclusion from participation in
government healthcare programs such as Medicare and Medicaid. Many of the existing requirements have not been definitively
interpreted by state authorities or courts, and available guidance is limited. Unless and until we are in full compliance with these laws,
we could face enforcement action and fines and other penalties, and could receive adverse publicity, all of which could materially harm
our business. In addition, changes in or evolving interpretations of these laws, regulations, or administrative or judicial interpretations,
may require us to change our business practices or subject our business practices to legal challenges, which could have a material adverse
effect on our business, financial condition and results of operations.

We May Experience Fluctuations in Our Financial Results or Fail to Meet Our Financial Projections.

Our operating results can fluctuate from quarter to quarter and year to year, which could cause our growth or financial performance to
fall below the expectations of investors and securities analysts. Our financial projections for future periods are based on a number of
assumptions, including estimated demand for our products. However, sales to our distributors and other customers may fall short of
expectations because of lower than estimated demand or other factors, including continued volatility and disruption in economic
conditions, increasing competition, seasonal fluctuations, changes in ordering patterns or business strategy, reduced governmental
funding and other circumstances described elsewhere in this Annual Report. Infrequent, unusual or unexpected changes in revenues or
costs could also contribute to the variability of our financial results.

Customers in certain of the markets we serve often submit a high percentage of purchase orders in the third month of a calendar quarter.
Although this can vary from quarter to quarter, many customers make purchase decisions late in a quarter due to budgetary or financial
requirements. In addition, certain governmental customers must fully spend budgeted funds by the end of their fiscal year or risk losing

these funds, which can contribute to fluctuations in our sales from year-to-year. This can make it difficult to accurately forecast whether
we will achieve our quarterly sales forecasts and can cause variability in our operating results.

In addition, our products provide different contributions to our gross margin. Accordingly, our operating results could also fluctuate and
be affected by the mix of products sold and the relative prices and gross margin contribution of those products. Failure to achieve
operating results consistent with the expectations of investors and securities analysts could adversely affect our reputation and the price
of our Common Stock.

We May Require Future Additional Capital.

Our future liquidity and ability to meet our future capital requirements will depend on numerous factors, including, but not limited to,
the following:

•

The costs, scope and timing of strategic acquisitions;

The costs and timing of expansion of sales and marketing activities;

The timing and success of the commercial launch of new products or services;

The extent to which we gain or expand market acceptance for existing, new or enhanced products and services;

The costs and timing of the expansion of our manufacturing and laboratory capacity;

The success of our research and product development efforts;

The time, cost and degree of success of conducting clinical trials and obtaining regulatory approvals;

The magnitude of capital expenditures;

Changes in existing and potential relationships with distributors and other business partners;

The costs involved in obtaining and enforcing patents, proprietary rights and necessary licenses;

The costs and liability associated with patent infringement or other types of litigation; and

Competing technological and market developments.

If additional financing is needed, we may seek to raise funds through the sale of equity or other securities or through bank borrowings.
There can be no assurance that financing through the sale of securities, bank borrowings or otherwise will be available to us on
satisfactory terms, or at all.

Terrorist Attacks, Natural Disasters, Public Health Crises, Political Unrest or Other Catastrophic Events Outside of Our
Control May Adversely Affect Our Business.

Terrorist attacks, natural disasters, including disasters attributable to climate change impacts, public health crises, political unrest or
other catastrophic events outside of our control, including pandemics, and subsequent governmental responses to these events, could
cause economic instability. These actions could adversely affect economic conditions both within and outside the United States and
reduce demand for our products. For example, the COVID-19 outbreak has led to, and for an unknown period of time will continue to
lead to, disruptions in local, regional, national and global markets and economies affected thereby, including the United States. This
outbreak has resulted in, and until fully resolved is likely to continue to result in, among other things: (i) restrictions on travel,
government mandated social distancing measures, and the temporary closure of many corporate offices, retail stores, and manufacturing
facilities and factories; (ii) significant disruption to the business of many companies, including our customers and suppliers, as well as
layoffs of employees; (iii) reduction or termination by public health and other customers of infectious disease testing programs, including
for HIV and HCV, and a reallocation of personnel and monetary resources from these programs to programs intended to address COVID-
19; (iv) reduction or termination of clinical and research studies by academic and other entities that use our molecular collection products
and laboratory services; and (v) rapidly evolving proposals and actions by state and federal governments to address the problems being
experienced by markets, businesses and the economy in general, which may have unintended consequences or may not adequately
address such problems. These events have disrupted, and threaten to continue to disrupt, our normal operation, the operations of our
customers and suppliers and eliminate, reduce or delay our customers’ ability to purchase and use our products and our suppliers’ ability
to provide raw materials and finished products. Despite our efforts to manage and mitigate the impact of these events on us, it is
impossible to predict the precise nature and consequences of these events, or of any political or policy decisions and regulatory changes
occasioned by emerging events or uncertainty under applicable laws or regulations that impact us. It is clear that these types of events
are impacting and will, for at least some time, continue to impact our product development and operation and in many instances the
impact may be adverse and may be material. Any potential impact to our results of operations will depend to a large extent on future

developments and new information that could emerge regarding the duration and severity of the COVID-19 pandemic and the actions
taken by authorities and other entities to contain the spread or treat its impact, all of which are beyond our control. These potential
impacts, while uncertain, could adversely affect our business and results of operation. In addition, the impacts of political unrest,
including as a result geopolitical tension, such as a deterioration in the relationship between the United States and China or escalation
in conflict between Russia and Ukraine, including any resulting sanctions, export controls or other restrictive actions that may be
imposed by the US and/or other countries against governmental or other entities in, for example, Russia, also could lead to disruption,
instability and volatility in the global markets, which may have an adverse impact on our business or ability to access the capital markets.

Various types of disasters, including earthquakes, fires, floods, riots, acts of terrorism and pandemics, may also affect our manufacturing
facilities and computer systems, and increase our cybersecurity risks. Although we have business interruption insurance, our facilities,
including some pieces of manufacturing equipment and our computer systems, may be difficult to replace and could require substantial
replacement lead-time. In the event our existing manufacturing facilities or computer systems are affected by man-made or natural
disasters, including pandemics, we may have difficulty operating our business and may be unable to manufacture products for sale or
meet customer demands or sales projections. If our manufacturing operations were curtailed or shut down entirely, it would seriously
harm our business. Moreover, we may incur incremental costs following an unforeseen event which could adversely affect our results
of operation.

The Ongoing Conflict Between Russia And Ukraine And The Related Implications Could Have A Material Adverse Effect On
Our Business And Results Of Operations.

As a result of the ongoing military conflict between Russia and Ukraine, the United States and other countries have imposed significant
sanctions on Russia and could impose even wider sanctions. Such sanctions could damage or disrupt international commerce and the
global economy. We cannot predict the broader or longer-term consequences of the conflict or of the sanctions imposed to date, which
could include embargoes, regional instability, geopolitical shifts, exchange rate fluctuations, financial market disruptions and economic
recession. Further, the conflict could exacerbate supply chain challenges, lead to an increase in cyberattacks from Russia, affect the
global price and availability of key commodities, reduce our sales and earnings or otherwise have an adverse effect on our business and
results of operations.

In addition, the conflict between Russia and Ukraine may have the effect of heightening other risks disclosed in this Annual Report, any
of which could materially and adversely affect our business and results of operations. Such risks include but are not limited to
interruptions in the transportation channels for the manufacture and global distribution of our products, heightened inflation, depressed
levels of consumer and commercial spending, disruptions to our global technology infrastructure, adverse changes in international trade
policies and relations, and the inability to implement and execute our business strategy. We are currently unable to predict the extent,
nature or duration of any of these occurrences.

Future Sales of Shares of Our Common Stock Could Adversely Affect the Trading Price of Our Common Stock and Our Ability
to Raise Funds in New Equity Offerings.

Future sales of a substantial number of our shares of Common Stock or equity-related securities in the public market or privately, or the
perception that such sales may occur, could adversely affect prevailing trading prices of our Common Stock, and could impair our ability
to raise capital through future offerings of equity or equity-related securities. No prediction can be made as to the effect, if any, that
future sales of shares of Common Stock or the availability of shares of Common Stock for future sale will have on the trading price of
our Common Stock.

ITEM 1B. Unresolved Staff Comments.

None

ITEM 2.

Properties.

We own a 31,700 square foot facility that houses our primary corporate office, our sales and marketing, research and development,
human resources, and regulatory and quality offices, a 48,000 square foot facility and a 33,500 square foot facility which are used for
manufacturing activities, and we lease an additional 139,000 square foot manufacturing facility, which is primarily dedicated to the
production of our InteliSwab® COVID-19 Rapid Tests. Each of these facilities is located in Bethlehem, Pennsylvania. We also rent
additional warehouse and distribution space on an as-needed basis, including a 70,000 square foot warehouse in Bethlehem Township,
Northampton County, Pennsylvania.
In November 2022, we terminated our lease for a facility in York, Pennsylvania, which was
intended for use in manufacturing activities. Given the improvements in manufacturing efficiency we were able to realize at our other
facilities, we determined that this additional space was not necessary. We were not required to pay termination fees. Our subsidiary,

DNAG, also leases a 35,883 square foot facility in Ottawa, Canada, which is used as its primary corporate office and houses sales and
marketing, manufacturing, distribution, research and development, and regulatory and quality operations. Our other subsidiaries,
Diversigen and Novosanis, also lease facilities for their operations.

We believe that the facilities described above are adequate for our current requirements.

ITEM 3. Legal Proceedings.

From time to time, we are involved in certain legal actions arising in the ordinary course of business. In management’s opinion, the
outcomes of such actions, either individually or in the aggregate, are not expected to have a material adverse effect on our future
financial position or results of operations.

In March 2021, we filed a complaint against Spectrum Solutions, LLC ("Spectrum") in the United States District Court for the Southern
District of California alleging that certain saliva collection devices manufactured and sold by Spectrum infringe a patent held by DNAG.
Spectrum has filed an answer to the initial complaint, asserting that its device does not infringe our patent and that our patent is invalid.
In August 2021, we amended our complaint to add a second patent to this litigation. Spectrum responded to our amended complaint and
asserted counterclaims for inequitable conduct and antitrust violations with respect to one of the patents in the litigation and subsequently
filed a request for review of the second patent at the Patent and Trademark Office. DNAG filed a motion to dismiss Spectrum’s
counterclaims in October 2021, which was denied by the Court on March 30, 2022. Expert discovery is ongoing. On November 29,
2022, the district court issued a claim construction order. On January 30, 2023, Spectrum filed a motion for summary judgment of
noninfringement. We opposed the motion. Briefing is complete and the motion remains pending. The final pretrial conference is set for
September 7, 2023. The Patent and Trademark Office instituted review of the second patent on February 10, 2023, scheduling a hearing
for November 14, 2023.

ITEM 4. Mine Safety Disclosures.

Not Applicable.

PART II

ITEM 5.

Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.

Market Information

Our Common Stock is listed for trading on the Global Select Market tier of The Nasdaq Stock Market LLC (“Nasdaq”) under the symbol
“OSUR”. On February 17, 2023, there were 290 holders of record and approximately 22,603 holders in street name of our Common
Stock, and the closing price of our Common Stock was $5.95 per share.

Dividends

We have never paid any cash dividends and our Board of Directors does not anticipate paying cash dividends in the foreseeable future.
We intend to retain any future earnings to provide funds for the operation and expansion of our business.

Share Repurchases and Retirements

Period

October 1, 2022 - October 31, 2022
November 1, 2022 - November 30, 2022
December 1, 2022 - December 31, 2022

Total number of
shares purchased

Average price
paid per Share

1,110 (3)
47,823 (3)
1,707 (3)
50,640

3.97
4.81
4.96

Total number of
shares purchased
as part of publicly
announced plans
or programs

Maximum number (or
approximate dollar value)
of shares that may yet be
repurchased under the plans
or programs (1, 2)

—
—
—
—

11,984,720
11,984,720
11,984,720

(1)

(2)

(3)

On August 5, 2008, our Board of Directors approved a share repurchase program pursuant to which we are permitted to acquire
up to $25.0 million of outstanding shares. This share repurchase program may be discontinued at any time.
This column represents the amount that remains available under the $25.0 million repurchase plan, as of the period indicated. We
have made no commitment to purchase any shares under this plan.
Pursuant to the OraSure Technologies, Inc. Stock Award Plan, and in connection with the vesting of restricted and performance
shares, these shares were retired to satisfy minimum tax withholdings

Performance Graph

The performance graph set forth below shall not be deemed “soliciting material” or “filed” for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to liability under that Section. This graph will not be
deemed “incorporated by reference” into any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether such
filing occurs before or after the date hereof, regardless of any general incorporation language in such filing.

The following graph compares the cumulative total returns to investors in the Company’s Common Stock, the Nasdaq Composite Index,
the Nasdaq Biotechnology Index, and the Nasdaq Health Care Index for the period from December 31, 2017 through December 31,
2022. The graph assumes that $100 was invested on December 31, 2017 in the Company’s Common Stock and in each of the above-
mentioned indices, and that all dividends, if any, were reinvested.

The Nasdaq Composite Index was chosen because it is a broad index of companies whose equity securities are traded on Nasdaq. The
Nasdaq Biotechnology Index (old peer group) was historically chosen because it includes a number of our competitors. We have chosen
to replace the Nasdaq Biotechnology Index with the Nasdaq Health Care Index (new peer group) because we believe it better reflects
companies relevant to our current business, and we utilize the Nasdaq Health Care Index as a benchmark for compensation decisions.
Furthermore, many healthcare investors look to the Nasdaq Health Care Index as an appropriate benchmark for stock performance. We
will discontinue using the Nasdaq Biotechnology Index after this Annual Report. Stockholders are cautioned that the graph shows the
returns to investors only as of the dates noted and may not be representative of the returns for any other past or future period.

OraSure Technologies, Inc.
NASDAQ Composite
NASDAQ Biotechnology
NASDAQ Health Care

2017
100.00
100.00
100.00
100.00

Fiscal year ending December 31,
2021
2018
46.08
61.93
235.15
97.16
144.18
91.14
106.27
83.86

2019
42.58
132.81
114.02
92.88

2020
56.12
192.47
144.15
118.12

2022
25.56
158.65
129.59
79.91

Securities Authorized for Issuance Under Equity Compensation Plans

For certain information concerning securities authorized for issuance under our equity compensation plan, see Item 12, “Security
Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.”

Item 6. Reserved

Not Applicable

ITEM 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

Statements below regarding future events or performance are “forward-looking statements” within the meaning of the Private Securities
Litigation Reform Act of 1995. Our actual results could be quite different from those expressed or implied by the forward-looking
statements. Factors that could affect results are discussed more fully under the Item 1A, entitled “Risk Factors,” and elsewhere in this
Annual Report. Although forward-looking statements help to provide complete information about us, readers should keep in mind that
forward-looking statements may not be reliable. Readers are cautioned not to place undue reliance on the forward-looking statements.
We undertake no duty to update any forward-looking statements made herein after the date of this Annual Report.

The following discussion should be read in conjunction with the consolidated financial statements contained herein and the notes thereto,
along with the Section entitled “Critical Accounting Policies and Estimates,” set forth below. This section of this Annual Report on
Form 10-K for the year ended December 31, 2022 (this "Annual Report") generally discusses 2022 and 2021 items and year-to-year
comparisons between 2022 and 2021. Discussion of 2020 items and year-to-year comparisons between 2021 and 2020 that are not
included in this Annual Report can be found in “Management’s Discussion and Analysis of Financial Condition and Results of
Operations” in Part II, Item 7 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2021.

Business Overview

Our primary goal is to empower the global community to improve health and wellness by providing access to accurate essential
information through effortless tests, collection kits and services. Through December 31, 2022 our business consisted of two segments:
our “Diagnostics” segment and our “Molecular Solutions" segment.

In February 2023, we announced a corporate restructuring to combine the commercial and innovation teams across the two segments
into one business unit, with sales, marketing, product development and research teams covering multiple product lines. This change is
intended to accelerate innovation, enhance customer experience and result in operational synergies. Beginning with the first quarter of
2023, we will report financial results on a non-segmented basis.

Our Diagnostics business primarily consists of the development, manufacture, marketing and sale of simple, easy to use diagnostic
products and specimen collection devices using our proprietary technologies, as well as other diagnostic products including
immunoassays and other in vitro diagnostic tests that are used on other specimen types. The Diagnostics business includes tests for
diseases including COVID-19, HIV and Hepatitis C that are performed on a rapid basis at the point of care, and tests for drugs of abuse
that are processed in a laboratory. These products are sold in the United States and internationally to various clinical laboratories,
hospitals, clinics, community-based organizations, and other public health organizations, distributors, government agencies, physicians’
offices, and commercial and industrial entities. Our COVID-19 and HIV products are also sold in a consumer-friendly format in the
over-the-counter (“OTC”) market in the U.S. and, in the case of the HIV product, as a self-test to individuals in a number of other
countries. In 2022, after obtaining a CE mark, we launched our OraQuick® HIV Self-Test, an oral swab in-home test for HIV-1 and
HIV-2, in Europe, making it available in several European countries. Through our Diagnostics business we are also developing and
commercializing diagnostic products that measure adherence to HIV medications including pre-exposure prophylaxis ("PrEP"). In
September 2022, we entered into an agreement with the Biomedical Advanced Research Development Authority ("BARDA"), pursuant
to which BARDA will provide up to $8.6 million in funding to us to develop a 2nd generation Ebola test on the OraQuick® testing
platform, with the objective of developing increased sensitivity and shelf life, with new chemistry and higher degrees of automation in
the test's manufacturing process.

Our Molecular Solutions business is operated by our wholly-owned subsidiaries, DNA Genotek Inc. ("DNAG"), Diversigen, Inc.
("Diversigen"), and Novosanis NV ("Novosanis"). Our Molecular Solutions business sells its products and services directly to its
customers, primarily through its internal sales force in the U.S. domestic market, and in many international markets, also through
distributors. Our products primarily consist of collection kits and services used by clinical laboratories, direct-to-consumer laboratories,
researchers, pharmaceutical companies, and animal health service and product providers. Most of our Molecular Solutions revenues are
derived from product sales to commercial customers and sales into the academic and research markets. A significant portion of our total
sales is from repeat customers in both markets. Molecular Solutions customers span the disease risk management, diagnostics,
pharmaceutical, biotech, nutrition, companion animal and environmental markets.

In 2020, we expanded the market focus of our Molecular Solutions business by selling existing collection products for use with COVID-
19 tests. In 2022, demand for COVID-19 PCR testing declined, which was primarily driven by the availability of antigen tests, the
reduction in the number of COVID-19 cases, and the wider availability of vaccines which negatively impacted the sales of the collection
products. We have also developed additional collection devices for the emerging microbiome market, which focuses on studying
microbiomes and their effect on human and animal health. In 2022, we launched the OMNIgene® • GUT Dx collection device (OMD-
200), which was granted De Novo authorization from the FDA for collection of human fecal samples and the stabilization of DNA from
the bacterial community for subsequent assessment of the microbiome profile by an assay validated for use with OMNIgene®·GUT Dx
device. Additionally, our OMNIgene® • GUT DNA and RNA collection device (OMR-205), became available to gut microbiome
researchers, allowing for self-collection, stabilization, storage and transportation of microbial DNA and RNA at ambient temperature

for gut microbiome profiling. We leverage our existing sales force and global research connections to engage microbiome customers
worldwide to establish ourselves among the leaders in ease-of-collection, stabilization, and transport of this challenging sample type.
Through our partnership with Grifols, we received FDA clearance for our ORAcollect®•Dx saliva collection device for OTC use, which
allows our commercial partners to use and market the device with their therapeutics or devices.

Our Molecular Solutions products include the Colli-Pee® device, developed and sold by our Novosanis subsidiary, for the volumetric
collection of first void urine. This product is in its early stages, and initial sales are occurring primarily through distributors and
collaborations in the liquid biopsy and sexually transmitted disease markets. In 2022, Novosanis obtained a CE mark for its Colli-Pee®
device containing a prefilled tube with UAS® chemistry, which is designed to stabilize urinary analytes. Our Diversigen subsidiary, also
offers laboratory and analytical services for both genomics and microbiome customers to more fully meet their needs. These services
are primarily provided to pharmaceutical, biotech companies, and research institutions.

In 2022, Diversigen launched its metatranscriptomics sequencing and analysis services for gut microbiome samples, which generate a
microbial community's gene expression profile to provide information about the interactions between an individual and their
microbiome, creating a holistic picture of a sample's microbial functions and expression levels.

Recent Developments

Restructuring

In February 2023, we announced a corporate restructuring to combine the commercial and innovation teams across the Molecular and
Diagnostics segments into one business unit with sales, marketing, product development and research teams covering multiple product
lines. This change is intended to accelerate innovation, enhance customer experience and result in operation synergies.

Impact of COVID-19

As COVID-19 continues to impact the economy of the United States and other countries around the world, we are committed to being
a part of the response to this unprecedented challenge. We have made substantial investments to expand our operations in order to
manufacture product used for COVID-19 testing in the United States.

Due to COVID-19, we have experienced volatility, including periods of material decline compared to prior year periods in testing
volume of our base business (which excludes COVID-19 testing) and periods of significant demand for our COVID-19 testing product,
with demand generally fluctuating in line with changes in prevalence of the virus and related variants. It is difficult for us to predict the
duration or magnitude of the outbreak’s effects on our business or results of operations.

We expect that, if and when the current COVID-19 pandemic subsides, there could be significantly reduced demand for testing, and
thus, for our InteliSwab® COVID-19 Rapid Tests. Further, if the COVID-19 pandemic becomes a seasonal virus or experiences
fluctuations in prevalence, we could experience fluctuations in our revenues associated with our InteliSwab® COVID-19 Rapid Tests
For additional information on COVID-19 related risks we face, see the “Risk Factors - Risks Relating to Products, Marketing and Sales
- The COVID-19 pandemic continues to cast uncertainty over our consolidated results of operations, financial position and cash flows,
while the consequences of COVID-19 and the governmental response to the pandemic and pandemic-related macroeconomic impacts
could negatively affect our operations and share price.” section of this Annual Report.

Appointment of New CEO

Carrie Eglinton Manner was appointed President and Chief Executive Officer ("CEO"), effective June 4, 2022. Ms. Eglinton Manner
also joined the OraSure Board of Directors (the "Board"). She succeeded Dr. Nancy Gagliano, who was appointed Interim CEO in
March 2022. Dr. Gagliano continues to serve on the OraSure Board.

Exploration of Strategic Alternatives

During 2022 our Board of Directors explored and evaluated a broad range of strategic alternatives with the goal of maximizing value
for stockholders. Ms. Eglinton Manner’s appointment as CEO came in tandem with a decision by the OraSure Board to conclude its
review of the strategic alternatives and for the Company to move forward under her leadership. Market conditions and the Board of
Directors' belief in our ability to further build upon recent operational successes with Ms. Eglinton Manner’s leadership were factors in
the decision.

BARDA Funding for Ebola Product

In September 2022, we entered into an agreement with BARDA, which is part of the office of the Assistant Secretary for Preparedness
and Response, pursuant to which BARDA will provide up to $8.6 million in funding to us to develop a 2nd generation Ebola test on the
OraQuick® testing platform. Our current OraQuick® Ebola Rapid Antigen Test is de novo authorized for use with whole blood or
cadaveric oral fluid. The test received de novo authorization from the FDA in 2019, making it the first and only rapid antigen test to
receive authorization for the detection of Ebola virus.

New Contract for In-Home HIV Tests

In September 2022, we were selected to provide our OraQuick® In-Home HIV tests in support of the CDC's “Together Take Me Home,”
HIV self-test program. Under the program, the CDC will provide $41.5 million over a five-year period to support community testing.
Emory University will manage the program and closely collaborate with a number of partner organizations, including OraSure, to supply
tests to communities not equitably reached by HIV testing services across the United States. Under the "Together Take Me Home" HIV
self-test program, we will provide up to 1 million OraQuick® In-Home HIV tests over a five-year period. A free HIV self-test will be
mailed in discreet packages to people who enroll through its website. The program will target populations that are disproportionately
affected by HIV and less likely to have access to key prevention services.

U.S. Government Contract Awards

In September 2021, we entered into a contract with the DLA for the procurement of our InteliSwab® COVID-19 Rapid Test for OTC
use, which the DLA estimated to have a value of $205 million. Under the terms of the contract, we are providing our InteliSwab®
COVID-19 Rapid Tests to up to 20,000 sites throughout the United States. The contract period was October 2021 through September
2022, however the DLA has provided delivery orders against which it can continue to issue shipping instructions into 2023.

In November 2022, the DLA awarded us a second procurement contract for our InteliSwab® COVID-19 Rapid Test for OTC use. Under
the terms of this award, the contract estimate is 18 million InteliSwab® COVID-19 Rapid Tests; with a maximum award of 36 million
tests and a guaranteed minimum award of 3.6 million tests. The contract will run from November 2022 through November 2023.

In December 2022, the HHS awarded a third procurement contract for our InteliSwab® COVID-19 Rapid Test for OTC use. Under the
terms of this contract we were awarded a fully funded firm fixed price contract for a total of 3.2 million tests to be delivered in the first
quarter of 2023.

DOD Manufacturing Capacity Funding

In September 2021, we entered into an agreement for $109 million in funding from the DOD, in coordination with the Department of
Health and Human Services, to build additional manufacturing capacity in the United States for our InteliSwab® COVID-19 Rapid Test
as part of the nation's pandemic preparedness plan. Under this agreement, the funding will be used to expand our production capacity
by 100 million tests annually. Funding is received based on the achievement of milestones for the design, acquisition, installation,
housing, qualification and acceptance of the manufacturing equipment as set forth in the agreement. We continue to invest time and
money to build the additional manufacturing capacity as required under this agreement. We anticipate that we will complete the
requirements of the contract by the end of 2023. Since the inception of the contract, we have received $60.3 million in funding.

Current Consolidated Financial Results

During the year ended December 31, 2022, our consolidated net revenues increased 66% to $387.5 million, compared to $233.7 million
for the year ended December 31, 2021. Net product and services revenues during the year ended December 31, 2022 increased 67%
when compared to the same period of 2021, largely due to $233.7 million of InteliSwab® COVID-19 Rapid Test revenue recorded in
2022, compared to $22.7 million in 2021. We first began selling this product in August of 2021. Also contributing to the increased
revenues were higher sales of our hepatitis C ("HCV") and substance abuse testing products. Declines in sales of our molecular sample
collection kits for COVID-19 testing, lower genomics product revenue, lower laboratory services revenues and a decline in international
sales of our HIV products offset these positive drivers of revenue. Other revenues for the year ended December 31, 2022 were $9.4
million compared to $6.8 million in the same period of 2021. This increase was largely due to increased research and development
funding associated with our InteliSwab® COVID-19 rapid test offset by a decrease in royalty income.

Our consolidated net loss for the year ended December 31, 2022 was $17.9 million, or $0.25 per share on a fully diluted basis, compared
to a consolidated net loss of $23.0 million, or $0.32 per share on a fully diluted basis, for the year ended December 31, 2021. Results
for the full-year 2022 benefited from the increased revenues in 2022 compared to 2021. The benefit of the higher revenues was offset
by the negative impact of $17.1 million of impairment charges taken for idle manufacturing lines and goodwill. There were no similar
charges in the 2021. 2022 results also included higher spending in operating expenses across all categories.

Cash used in operating activities during the year ended December 31, 2022 was $47.2 million compared to $35.4 million used in the
year ended December 31, 2021. The use of cash in 2022 reflected the significant investment in inventory purchases in anticipation of
future demand of our COVID-19 testing products as well the increase in our accounts receivable balances resulting largely from COVID-
19 shipments made toward the end of the fourth quarter of 2022. As of December 31, 2022, we had $110.8 million in cash, cash
equivalents, and available-for-sale securities, compared to $170.1 million at December 31, 2021.

Results of Operations

YEAR ENDED DECEMBER 31, 2022 COMPARED TO DECEMBER 31, 2021

CONSOLIDATED NET REVENUES

The table below shows a breakdown of total net revenues (dollars in thousands) generated by each of our business segments.

Diagnostics
Molecular Solutions

Net product and services revenues

Other

Net revenues

For the Year Ended December 31,

Dollars

2022
$ 296,663
81,384
378,047
9,432
$ 387,479

2021
87,030
139,867
226,897
6,777
$ 233,674

Percentage of Total Net
Revenues

% Change

2022

2021

241 %
(42)
67
39
66 %

77 %
21
98
2
100 %

37 %
60
97
3
100 %

Consolidated net product and services revenues increased 67% to $378.0 million for the year ended December 31, 2022 from $226.9
million for 2021. This increase was largely driven by higher sales of our InteliSwab® COVID-19 Rapid Tests, and our HCV and
substance abuse testing products. The increase was partially offset by declines in revenues of our molecular product use for COVID-
19 testing, our molecular product used for genomic testing, and lower laboratory services revenues. Other revenues for the year ended
December 31, 2022 were $9.4 million compared to $6.8 million in 2021. This increase was largely due to increased research and
development funding associated with our InteliSwab® COVID-19 rapid test offset by a decrease in royalty income.

Consolidated net revenues derived from products sold to customers outside of the United States were $37.3 million and $45.3 million,
or 10% and 19% of total net revenues, during the years ended December 31, 2022 and 2021, respectively. Because the majority of our
international sales are denominated in U.S. dollars, the impact of fluctuating foreign currency exchange rates was not material to our
total consolidated net revenues.

Net Revenues by Segment

Diagnostics Segment

The table below shows the amount of total net revenues (dollars in thousands) generated by our Diagnostics segment.

Market
Infectious disease testing:

COVID-19
Other

Total infectious disease testing
Substance abuse testing
Net product revenues

Other

Net revenues

Infectious Disease Testing Market

For years ended December 31,

Dollars

Percentage of Total Net
Revenues

2022

2021

% Change

2022

2021

$ 233,666
52,728
286,394
10,269
296,663
7,010
$ 303,673

22,707
54,645
77,352
9,678
87,030
3,010
90,040

929 %
(4)
270
6
241
133
237 %

77 %
17
94
4
98
2
100 %

25 %
61
86
11
97
3
100 %

COVID-19 revenues were $233.7 million and $22.7 million for the years ended December 31, 2022 and 2021, respectively. This growth
was driven largely through fulfillment of our government procurement contracts for InteliSwab® tests. We first began selling this

product in August 2021. We are anticipating higher COVID-19 revenues in the first half of 2023 followed by lower revenues in the
second half of 2023, as we work down our government InteliSwab® COVID-19 rapid test contracts.

Sales to other infectious disease testing markets decreased 4% to $52.7 million for the year ended December 31, 2022 from $54.6 million
for the year ended December 31, 2021. This decline resulted from lower world-wide sales of our OraQuick® HIV product offset by
increased world-wide sales of our OraQuick® HCV products.

The table below shows a breakdown of our total net OraQuick® HIV and HCV product revenues (dollars in thousands) during 2022 and
2021.

Market
Domestic HIV
International HIV

Net HIV revenues

Domestic HCV
International HCV

Net HCV revenues
Net OraQuick® revenues

2022

Years ended December 31,
2021

% Change

16,241
22,571
38,812
8,353
5,016
13,369
52,181

16,641
25,503
42,144
6,881
4,902
11,783
53,927

(2) %
(11)
(8)
21
2
13
(3) %

Domestic OraQuick® HIV sales decreased 2% to $16.2 million for the year ended December 31, 2022 from $16.6 million for the year
ended December 31, 2021. The decline is primarily a result of a large order fulfilled in the first half of 2021 for our OraQuick® In-Home
HIV tests shipped to the CDC and use in an initiative to drive increased in-home HIV testing, which was not repeated in 2022. This
negative impact to sales was partially offset by improved distribution strategy with our distribution partners.

International sales of our OraQuick® HIV products during 2022 decreased 11% to $22.6 million from $25.5 million in 2021. This
decrease was largely due to customer order timing. This was partially offset by Our OraQuick® HIV Self-Test expansion into Europe.

Domestic OraQuick® HCV sales increased 21% to $8.4 million in 2022 from $6.9 million in 2021, driven by new funding granted by
certain state governments, increased legislation regarding drug testing and a rise in drug use requiring more testing. Furthermore this
part of our business also benefited from an improved distribution strategy with our distribution partners.

International OraQuick® HCV sales remained largely flat at $5.0 million in 2022 compared to $4.9 million in 2021.

Substance Abuse Testing Market

Sales to the substance abuse testing markets increased 6% to $10.3 million for the year ended December 31, 2022 from $9.7 million for
the year ended December 31, 2021 due to market share gains.

Other revenues

Other revenues for the year ended December 31, 2022 increased 133% to $7.0 million from $3.0 million for the year ended December 31,
2021 largely due to higher research and development funding for 510(k) clearance and CLIA waiver of our InteliSwab® COVID-19
rapid test. This was offset by lower royalty income from a licensing agreement related to our proprietary buffer solution used for the
preservation and stabilization of oral fluid specimens.

Molecular Solutions Segment

The table below shows a breakdown of total net revenues (dollars in thousands) generated by our Molecular Solutions segment for the
year ended December 31, 2022 and 2021.

Market
Genomics
Microbiome
COVID-19
Laboratory services
Other product and service revenues

Net molecular product and services revenues

Other

Net molecular product and services revenues

2022

Years ended December 31,
2021

% Change

54,335
7,503
9,659
7,296
2,591
81,384
2,422
83,806

63,350
7,944
54,167
11,840
2,566
139,867
3,767
143,634

(14) %
(6)
(82)
(38)
1
(42)
(36)
(42) %

Sales of our genomics products decreased 14% to $54.3 million in 2022 compared to $63.4 million in 2021, largely as a result of a shift
in market prioritization at our larger commercial customers and a reduction in demand in the animal genetics market.

Microbiome revenues decreased 6% to $7.5 million in 2022 compared to $7.9 million in 2021, due to decreased sales in the commercial
microbiome market. This was partially offset by the onboarding of new customers in the academic market.

Sales of our molecular sample collection kits for COVID-19 testing decreased 82% to $9.7 million in 2022 compared to $54.2 million
in 2021 due to lower COVID-19 PCR testing sales to our core customers, driven by the availability of antigen tests, the wider availability
of vaccines, lower public funding for PCR testing, and high inventory levels held by some of those customers.

Laboratory services revenues decreased 38% to $7.3 million in 2022 compared to $11.8 million in 2021, as a result of a large customer
ceasing its operations and the timing of clinical trials activity.

Other revenues decreased 36% to $2.4 million in 2022 compared to $3.8 million in 2021 due to lower royalty income received under a
litigation settlement agreement.

CONSOLIDATED OPERATING RESULTS

Consolidated gross profit percentage was 38% for the year ended December 31, 2022 compared to 50% for 2021. The decrease in gross
margins rates was caused by an unfavorable product mix of higher sales of lower margin products driven by the decline in molecular
COVID-19 revenues offset by an increase in InteliSwab® revenues. In addition, 2021 margins benefited from lower payroll taxes as
result of applying for an Employee Retention Credit under the Coronavirus Aid, Relief and Economic Security Act, which increased
gross profit by $2.5 million.

Consolidated operating loss in 2022 was $23.0 million, which was a $12.8 million increase from the $10.2 million of operating loss
reported in 2021. Results in 2022 were negatively impacted by the decline in gross margin described above coupled with impairment
charges of $17.1 million and the increased operating expenses described below.

OPERATING INCOME BY SEGMENT

Diagnostic Segment

The gross profit percentage of the Diagnostics business was 36% in 2022 compared to 29% in 2021. This increase was driven by an
improved product mix associated with the higher sales of InteliSwab® COVID-19 Rapid Tests. This was partially offset by lower payroll
taxes in 2021 as result of applying for the Employee Retention Credit which increased gross profit by $2.5 million in that year.

Research and development expenses increased 8% to $26.0 million in 2022 from $24.1 million in 2021, due to higher staffing costs
associated with increased head count, cost incurred under our DOD expansion contract which did not occur in 2021, and increased
clinical study activities related to obtaining CE mark for our InteliSwab® rapid test, partially offset by lower product development
activities related to our InteliSwab® rapid test as we received EUA authorization in June 2021. Also contributing to the higher spend
are consulting fees required under our DOD expansion contract. Similar fees did not occur in 2021.

Sales and marketing expenses increased 18% to $33.5 million in 2022 from $28.5 million in 2021, due to increased staffing costs
associated with higher head count, increased severance costs, and the inclusion of the Employee Retention Credit in 2021 results, which
did not repeat in 2022. Furthermore, travel and annual meeting expenses increased as travel and in person events have resumed as
COVID-19 restrictions have been lifted. In addition, we also recorded an increase in our reserve for uncollectible accounts. These higher
spend items were partially offset by a decrease in consulting fees.

General and administrative expenses increased 31% to $42.8 million in 2022 from $32.6 million in 2021 largely due to higher stock
compensation expense associated with accelerated vesting of shares under our former CEO's and general counsel's employment
agreements, higher staffing costs associated with increased head count and severance costs, increased legal costs, and increased
consulting and accounting fees.

Operating expenses for the Diagnostic segment also include an impairment charge of $4.9 million associated with an idle manufacturing
line for which it has no projected cash flows and minimal resale or salvage value. Diagnostic operating expenses also included a goodwill
impairment charge of $3.6 million. The decline in the Company's stock price was identified as a triggering event which required the
Company to perform a quantitative goodwill impairment analysis. The results of this analysis indicated the Diagnostic segment's
goodwill was impaired and was written down to $0.

All of the above contributed to the Diagnostics segment’s operating loss of $0.6 million for the year ended December 31, 2022, which
included non-cash charges of $8.1 million for depreciation and amortization, impairment charges of $8.5 million, and $9.3 million for
stock-based compensation.

Molecular Solutions Segment

The gross profit percentage of the Molecular Solutions segment was 46% in 2022 compared to 63% in 2021. This decrease was due to
a less favorable product mix and an increase in reserves for excess inventory as result of a forecasted decline in demand.

Research and development expenses remained relatively flat at $10.3 million in 2022 compared to $10.1 million in 2021.

Sales and marketing expenses decreased 4% to $15.7 million in 2022 compared to $16.3 million in 2021 largely due to lower
amortization expense associated with an intangible asset that was fully amortized at the end of 2021, lower commission expense
associated with the decline in sales, lower consulting costs, and a decrease in expense related to the cancellation of a marketing loyalty
program. These decreases in spend were partially offset by higher staffing costs related to increased head count.

General and administrative expenses increased 44% to $25.4 million in 2022 compared to $17.7 million in 2021, due primarily to higher
legal fees.

Operating expenses for the Molecular Solutions segment also includes impairment charges of $8.6 million in 2022 associated with
several idle manufacturing lines for which there are no projected cash flows and minimal resale or salvage value.

All of the above contributed to an operating loss of $22.4 million for 2022, which included non-cash charges of $7.2 million for
depreciation and amortization, the impairment charges of $8.6 million, and $2.3 million for stock-based compensation.

CONSOLIDATED INCOME TAXES

We continue to believe the full valuation allowance established in 2008 against our total U.S. deferred tax asset is appropriate as the
facts and circumstances necessitating the allowance have not changed. For the year ended December 31, 2022 and 2021, we recorded
income tax expense of $1.5 million and $13.7 million, respectively. 2022 income tax expense is comprised of $1.7 million of Canadian
withholding taxes paid on the repatriation of Canadian earnings which occurred in the first quarter of 2022, $0.9 million of U.S. state
income taxes, and a foreign income tax benefit of $1.2 million associated with our Canadian subsidiary. Our 2021 expense is comprised
of U.S. state income taxes of $0.2 million and foreign tax expense associated with our Canadian subsidiary of $13.5 million.

Liquidity and Capital Resources

Cash and cash equivalents
Available for sale securities
Working capital

December 31,
2022

December 31,
2021

(In thousands)

83,980 $
26,867
255,326

116,762
53,288
231,242

Our cash and cash equivalents and available-for-sale securities decreased to $110.8 million at December 31, 2022 from $170.0 million
at December 31, 2021. Our working capital increased to $255.3 million at December 31, 2022 from $231.2 million at December 31,
2021.

During the year ended December 31, 2022, net cash used in operating activities was $47.2 million. Our net loss of $17.9 million included
non-cash charges of $17.1 million associated with impairment charges taken for idle manufacturing lines and goodwill, depreciation
and amortization expense of $15.3 million, stock-based compensation expense of $11.6 million, deferred income tax benefit of $1.7
million, a decrease in reserve for uncollectible accounts of $1.0 million, and a decrease in inventory reserves of $0.8 million. Cash used
to fund our working capital accounts included an increase in inventory of $43.0 million to meet anticipated demand to support COVID-19
testing programs, an increase in accounts receivable of $25.2 million due to orders placed in the fourth quarter, an increase in prepaid
expenses and other assets of $7.1 million associated with tax installments made to the Canadian Revenue Agency and a decrease in
deferred revenue of $0.6 million due to the recognition of revenue from customer prepayments. Offsetting these uses of cash was a $4.0
million increase in accounts payable due to the timing of invoices received and payments made and a decrease in accrued expenses and
other liabilities of $1.4 million.

Net cash provided by investing activities was $21.1 million for the year ended December 31, 2022, which reflects proceeds from the
maturities and redemptions of investments of $47.4 million, offset by $22.9 million used to purchase investments. Investing activities
also included $6.8 million to acquire property and equipment and $57.1 million used to build additional manufacturing capacity as
required by the $109 million agreement with the DOD. This is offset by $60.3 million received from the DOD as reimbursement under
that contract.

Net cash used in financing activities was $3.8 million for the year ended December 31, 2022, which reflects $2.3 million used for the
repurchase of common stock to satisfy withholding taxes related to the vesting of restricted shares and performance stock units awarded
to our employees, payments of lease liabilities of $1.4 and payment of our contingent consideration obligation of $0.2 million.

We expect current balances of cash and cash equivalents and available-for-sale securities to be sufficient to fund our current and
foreseeable operating and capital needs. Our cash requirements, however, may vary materially from those now planned due to many
factors, including, but not limited to, the timing of reimbursement under our $109 million DOD contract, the scope and timing of future
strategic acquisitions, the progress of our research and development programs, the scope and results of clinical testing, the cost of any
future litigation, the magnitude of capital expenditures, changes in existing and potential relationships with business partners, the timing
and cost of obtaining regulatory approvals, the timing and cost of future stock purchases, the costs involved in obtaining and enforcing
patents, proprietary rights and any necessary licenses, the cost and timing of expansion of sales and marketing activities, market
acceptance of new products, competing technological and market developments, the impact of the current economic environment and
other factors. In addition, $71.0 million, or 64%, of our $110.8 million in cash, cash equivalents and available-for-sale securities belongs
to our Canadian subsidiary. In 2022, we repatriated $65 million of such cash into the United States and incurred approximately $1.7
million of Canadian withholding tax. Further repatriation of cash from Canada into the United States could have additional adverse tax
consequences. It is still our intention going forward to continue to permanently reinvest the historical undistributed earnings of our
foreign subsidiaries.

Critical Accounting Policies and Estimates

This Management’s Discussion and Analysis of Financial Condition and Results of Operations discusses our consolidated financial
statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America. The
preparation of these financial statements requires that we make judgments and estimates that affect the reported amounts of assets and
liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues
and expenses during the reporting period. We base our judgments and estimates on historical experience and on various other factors
that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying
value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under
different assumptions or conditions.

Our significant accounting policies are described in Note 2 of the Notes to the consolidated financial statements included in Item 15 of
this Annual Report. We consider the following accounting policies, which have been discussed with our Audit Committee, to be most
critical in understanding the more complex judgments that are involved in preparing our financial statements and the uncertainties that
could impact our results of operations, financial condition, and cash flows.

Revenue Recognition.

Product sales. Revenue from product sales is recognized upon transfer of control of a product to a customer based on an amount that
reflects the consideration we are entitled to, net of allowances for any discounts or rebates.

We generally do not grant product return rights to our customers, except for warranty returns and return rights on sales of our OraQuick®
In-Home HIV test to the retail trade, and InteliSwab® products to the retail trade and certain customers.

Historically, returns arising from warranty issues have been infrequent and immaterial. Accordingly, we expense warranty returns as
incurred.

Service Revenues

Service revenues represent microbiome laboratory testing and analytical services. We recognize revenues when we satisfy our
performance obligation for services rendered.

Arrangements with multiple-performance obligations

In arrangements involving more than one performance obligation, which largely applies to our service revenue stream, each required
performance obligation is evaluated to determine whether it qualifies as a distinct performance obligation based on whether (i) the
customer can benefit from the good or service either on its own or together with other resources that are readily available and (ii) the
good or service is separately identifiable from other promises in the contract. The consideration under the arrangement is then allocated
to each separate distinct performance obligation based on each respective relative stand-alone selling price. The estimated selling price
of each deliverable is determined using an observable cost plus margin approach. The consideration allocated to each distinct
performance obligation is recognized as revenue when control is transferred for the related goods or services or when the performance
obligation has been satisfied.

Inventories

Our inventories are stated at the lower of cost or net realizable value, with cost determined on a first-in, first-out basis, and include the
cost of raw materials, labor and overhead. The majority of our inventories are subject to expiration dating, which can be extended in
certain circumstances. We continually evaluate quantities on hand and the carrying value of our inventories to determine the need for
net realizable value adjustments, based primarily on prior experience with consideration of expected changes in the business and
estimated forecasts of product sales. We reserve for unidentified scrap or spoilage based on historical write-off rates. We also consider
items identified through specific identification procedures in assessing the adequacy of our reserve. Although we make every effort to
ensure the accuracy of our forecasts of future product demand, any significant unanticipated changes in demand could have a significant
impact on the carrying value of our inventories and reported operating results.

Goodwill

Goodwill is not amortized, but rather is tested annually for impairment or more frequently if we believe that indicators of impairment
exist. Current generally accepted accounting principles permit us to make a qualitative evaluation about the likelihood of goodwill
impairment and if it is determined that it is more likely than not that the fair value does not exceed the carrying amount, then a
quantitative test is performed. The quantitative goodwill impairment test involves a comparison of the estimated fair value of the
reporting unit to the respective carrying amount. An impairment charge is recognized in the amount by which the carrying amount
exceeds the reporting unit’s fair value, provided the impairment charge does not exceed the total amount of goodwill allocated to the
reporting unit.

The process of evaluating the potential impairment of goodwill is highly subjective and requires significant judgment, including the
identification of reporting units, qualitative evaluation of events and circumstances to determine if it is more likely than not that an
impairment exists, and, if necessary, the estimation of the fair value of the applicable reporting unit.

ITEM 7A. Quantitative and Qualitative Disclosures About Market Risk.

The information with respect to forward-looking statements within “Management’s Discussion and Analysis of Financial Condition and
Results of Operations” of this Annual Report is incorporated herein by reference.

We do not hold any amounts of derivative financial instruments or derivative commodity instruments and, accordingly, we have no
material derivative risk to report under this Item.

As of December 31, 2022, we did not have any foreign currency exchange contracts or purchase currency options to hedge local currency
cash flows. Sales denominated in foreign currencies comprised 2.0% of our total revenues for the year ended December 31, 2022. We
do have foreign currency exchange risk related to our operating subsidiaries in Canada and in Belgium. The principal foreign currencies
in which we conduct business are the Canadian dollar and the Euro. Fluctuations in the exchange rate between the U.S. dollar and these
foreign currencies could affect year-to-year comparability of operating results and cash flows. Our foreign subsidiaries had net assets,
subject to translation, of $120.3 million in U.S. Dollars, which are included in the Company’s consolidated balance sheet as of
December 31, 2022. A 10% unfavorable change in the Canadian-to-U.S. dollar and Euro-to-U.S. dollar exchange rates would have
increased our comprehensive loss by approximately $12.0 million in the year ended December 31, 2022.

ITEM 8.

Financial Statements and Supplementary Data.

Information with respect to this Item is contained in our Consolidated Financial Statements included under Item 15 of this Annual
Report.

ITEM 9.

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.

Not applicable.

ITEM 9A. Controls and Procedures.

(a) Evaluation of Disclosure Controls and Procedures.

The Company’s management, with the participation of the Company’s Chief Executive Officer, Chief Financial Officer and Chief
Accounting Officer, has evaluated the effectiveness of the Company’s disclosure controls and procedures (as defined in Rules 13a-15(e)
and 15d-15(e) of the Securities Exchange Act of 1934) as of December 31, 2022. Based on that evaluation, the Company’s management,
including such officers, concluded that as of December 31, 2022 the Company’s disclosure controls and procedures were effective to
provide reasonable assurance that information required to be disclosed by the Company in the reports that we file or submit under the
Securities Exchange Act of 1934 is accumulated and communicated to the Company’s management, including the Chief Executive
Officer, Chief Financial Officer and Chief Accounting Officer, to allow timely decisions regarding required disclosure and is recorded,
processed, summarized, and reported within the time periods specified in the rules and forms of the Securities and Exchange
Commission.

(b) Management’s Report on Internal Control Over Financial Reporting.

The Company’s management is responsible for establishing and maintaining adequate internal control over financial reporting, as such
term is defined in Rule 13a-15(f) and 15d-15(f) under the Securities Exchange Act of 1934. Under the supervision and with the
participation of the Company’s management, including our principal executive officer and principal financial officer, we conducted an
evaluation of the effectiveness of our internal control over financial reporting based on the framework in Internal Control - Integrated
Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on our evaluation under
the framework, our management concluded that our internal control over financial reporting was effective to provide reasonable
assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance
with generally accepted accounting principles as of December 31, 2022.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections
of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in
conditions, or that the degree of compliance with the policies or procedures may deteriorate.

The effectiveness of our internal control over financial reporting as of December 31, 2022 has been audited by KPMG LLP, an
independent registered public accounting firm, as stated in their report, which is included below.

During the quarter ended December 31, 2022, management identified and remediated a material weakness in internal control over
financial reporting related to user access controls to adequately restrict access over our information technology system that supports our
financial reporting processes. No misstatement arose as a result of this deficiency.

Except for the foregoing, there was no change in our internal control over financial reporting identified in management’s evaluation
pursuant to Rules 13a or 15d of the Exchange Act that occurred during the quarter ended December 31, 2022 that has materially affected,
or is reasonably likely to materially affect, our internal control over financial reporting.

(d) Report of Independent Registered Public Accounting Firm.

To the Stockholders and Board of Directors
OraSure Technologies, Inc.:

Opinion on Internal Control Over Financial Reporting
We have audited OraSure Technologies, Inc. and subsidiaries' (the Company) internal control over financial reporting as of December
31, 2022, based on criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring
Organizations of the Treadway Commission. In our opinion, the Company maintained, in all material respects, effective internal
control over financial reporting as of December 31, 2022, based on criteria established in Internal Control – Integrated Framework
(2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States)
(PCAOB), the consolidated balance sheets of the Company as of December 31, 2022 and 2021, the related consolidated statements of
operations, comprehensive income (loss), stockholders’ equity, and cash flows for each of the years in the three-year period ended
December 31, 2022, and the related notes (collectively, the consolidated financial statements), and our report dated March 3, 2023
expressed an unqualified opinion on those consolidated financial statements.

Basis for Opinion
The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of
the effectiveness of internal control over financial reporting, included in the accompanying Management’s Report on Internal Control
Over Financial Reporting. Our responsibility is to express an opinion on the Company’s internal control over financial reporting based
on our audit. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the
Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange
Commission and the PCAOB.

We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit
to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects.
Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial reporting,
assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control
based on the assessed risk. Our audit also included performing such other procedures as we considered necessary in the circumstances.
We believe that our audit provides a reasonable basis for our opinion.

Definition and Limitations of Internal Control Over Financial Reporting
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of
financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting
principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the
maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the
company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in
accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in
accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding
prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect
on the financial statements.

/s/ KPMG LLP

Philadelphia, Pennsylvania
March 3, 2023

ITEM 9B. Other Information.

Not applicable.

ITEM 9C. Disclosure regarding Foreign Jurisdictions that Prevent Inspections

Not applicable.

PART III

We have omitted from Part III the information that will appear in our Definitive Proxy Statement for our 2023 Annual Meeting of
Stockholders (the “2023 Proxy Statement”), which will be filed within 120 days after the end of our fiscal year pursuant to Regulation
14A.

ITEM 10. Directors, Executive Officers and Corporate Governance.

The information required by this Item 10 will be included in our 2023 Proxy Statement and is incorporated herein by reference. Our
Board of Directors has adopted a Code of Business Conduct and Ethics that applies to our principal executive officer, principal financial
officer and principal accounting officer, as well as to the members of our Board of Directors and our other officers and employees. This
Code of Business Conduct and Ethics is available on our website at www.orasure.com. We intend to satisfy the amendment and waiver
disclosure requirements under applicable securities regulations by posting any amendments of, or waivers to, the Code of Business
Conduct and Ethics on our website.

ITEM 11. Executive Compensation.

The information required by this Item 11 will be included in our 2023 Proxy Statement and is incorporated herein by reference.

ITEM 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.

The information required by this Item 12 will be included in our 2023 Proxy Statement and is incorporated herein by reference.

ITEM 13. Certain Relationships and Related Transactions, and Director Independence.

The information required by this Item 13 will be included in our 2023 Proxy Statement and is incorporated herein by reference.

ITEM 14.

Principal Accountant Fees and Services.

The information required by this Item 14 will be included in our 2023 Proxy Statement and is incorporated herein by reference.

PART IV

ITEM 15. Exhibits and Consolidated Financial Statement Schedules.

(a)(1) and (a)(2). Consolidated Financial Statements and Schedules. For a list of the consolidated financial statements filed herewith,
see the Index to Consolidated Financial Statements following the signature page to this Annual Report. No schedules are included with
the consolidated financial statements because the required information is inapplicable or is presented in the consolidated financial
statements or related notes thereto.

(a)(3). Exhibits.

Exhibit
Number
3.1.1

3.1.2

3.2

4.1

10.1

10.2

10.3

10.4

10.5+

10.6

10.7

10.8

10.9

10.10

10.11

Exhibit
Certificate of Incorporation of OraSure Technologies, Inc. is incorporated by reference to Exhibit 3.1 to the Company’s
Registration Statement on Form S-4 (No. 333-39210), filed June 14, 2000.

Certificate of Amendment to Certificate of Incorporation dated May 23, 2000 is incorporated by reference to Exhibit 3.1.1
to the Company’s Registration Statement on Form S-4 (No. 333-39210), filed June 14, 2000.

Bylaws of OraSure Technologies, Inc., as amended and restated as of February 19, 2018, are incorporated by reference to
Exhibit 3.2 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2017.

Description of Securities is incorporated by reference to Exhibit 4.1 to the Company’s Annual Report on Form 10-K for the
year-ended December 31, 2019.

Employment Agreement dated as of January 3, 2018, between OraSure Technologies, Inc. and Stephen S. Tang, Ph.D., is
incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed January 4, 2018.*

Transition Agreement dated as of January 2, 2022, between OraSure Technologies, Inc. and Stephen S. Tang, Ph.D. is
incorporated by reference to Exhibit 10.1 to the Company's Current Report on Form 8-k filed January 6, 2022*

Employment Agreement, dated as of January 1, 2019, between Kathleen G. Weber, DNA Genotek, Inc. and OraSure
Technologies, Inc. is incorporated by reference to Exhibit 10.21 to the Company’s Annual Report on Form 10-K for the
year ended December 31, 2018.*

Amendment No. 1 to Employment Agreement, dated as of December 20, 2021, between Kathleen G. Weber, DNA Genotek,
Inc. and OraSure Technologies, Inc. is incorporated by reference to exhibit 10.10 to the Company's Annual Report on form
10-K for the year ended December 31, 2021*

Amendment No. 2 to Employment Agreement, dated as of November 7, 2022, between Kathleen G. Weber, DNA Genotek,
Inc. and OraSure Technologies, Inc.*

Employment Agreement, dated as of May 11, 2020, between OraSure Technologies, Inc. and Lisa Nibauer is incorporated
by reference to Exhibit 10.2 to the Company’s Quarterly Report on form 10-Q for the quarter ended June 30, 2020.*

Employment Agreement, dated as of November 29, 2021, between OraSure Technologies, Inc. and Agnieszka M.
Gallagher. is incorporated by reference to Exhibit 10.12 to the Company's Annual Report on Form 10-K for the year ended
December 31, 2021.*

Employment Agreement dated as of March 21, 2022, between OraSure Technologies, Inc. and Nancy J. Gagliano, M.D.,
M.B.A. is incorporated by reference to item 10.1 to the Company's Current Report on Form 8-K filed on March 23, 2022*

Employment Agreement, dated as of May 20, 2022, between OraSure Technologies, Inc. and Carrie Eglinton-Manner is
incorporated by reference to exhibit 10.1 to the company's Current Report on Form 8-K filed on May 26, 2022.

Employment Agreement dated August 8, 2022, between OraSure Technologies, Inc. and Kenneth J. McGrath is
incorporated by reference to Exhibit 10.1 to the Company's Current Report on Form 8-K filed on August 12, 2022.*

Severance Letter Agreement, dated August 25, 2021, between OraSure Technologies, Inc. and Michele M. Miller is
incorporated by reference to Exhibit 10.13 to the Company's Annual Report on Form 10-K for the year ended December
31, 2021.*

10.12 Description of Non-Employee Director Compensation Policy, as amended, is incorporated by reference to Item 5.02 to the

Company’s Current Report on form 8-K filed August 14, 2019.*

10.13 Amended and Restated Epitope, Inc. 1991 Stock Award Plan is incorporated by reference to Exhibit 10.9 to the Company’s

Annual Report on Form 10-K for the year ended December 31, 2002.*

10.14 OraSure Technologies, Inc. Employee Incentive and Non-Qualified Stock Option Plan, as amended and restated effective
September 29, 2000, is incorporated by reference to Exhibit 10.12 to the Company’s Annual Report on Form 10-K for the
year ended December 31, 2000.*

10.15 Amended and Restated OraSure Technologies, Inc. Stock Award Plan, effective April 4, 2020, is incorporated by reference

to Exhibit A to the Company’s Proxy Statement, filed April 9, 2020, for the 2020 Annual Meeting of Stockholders.*

10.16 Amended and Restated OraSure Technologies, Inc. 2000 Stock Award Plan, Effective April 1, 2022, is incorporated by

reference to Exhibit 10.1 to the Company's Current Report on Form 8-K filed May 18, 2022.*

10.17

10.18

10.19

10.20

Form of Restricted Share Award Agreement (Executive Officers – Employment Agreements) is incorporated by reference
to Exhibit 10.24 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2015.*

Form of Restricted Unit Award Agreement (Executive Officers – Employment Agreements) is incorporated by reference to
Exhibit 10.27 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2016. *

Form of Restricted Unit Award Agreement (Executive Officers-Employment Agreements) for 2021 awards is incorporated
by reference to Exhibit 10.20 to the Company's Annual Report on Form 10-K for the year ended December 31, 2021.*

Form of Restricted Share Grant Agreement (Non-Employee Directors) is incorporated by reference to Exhibit 10.24 to the
Company’s Annual Report on Form 10-K for the year ended December 31, 2011.*

10.21 Nonqualified Stock Option Award General Terms and Conditions (Executive Officers) is incorporated by reference to

Exhibit 10.25 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2011.*

10.22 Nonqualified Stock Option Award General Terms and Conditions (Non-Employee Directors) is incorporated by reference

to Exhibit 10.26 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2011.*

10.23 OraSure Technologies, Inc. Deferred Compensation Plan is incorporated by reference to Exhibit 99.1 to the Company’s

Current Report on Form 8-K filed December 21, 2011.*

10.24 Adoption Agreement related to OraSure Technologies, Inc. Deferred Compensation Plan is incorporated by reference to

Exhibit 99.2 to the Company’s Current Report on Form 8-K filed December 21, 2011.*

10.25 Amended and Restated Code of Business Conduct and Ethics of OraSure Technologies, Inc. is incorporated by reference to

Exhibit 14.1 to the Company’s Current Report on Form 8-K filed November 10, 2021.

10.26

10.27

23+

24+

31.1+

31.2+

32.1+

32.2+

$109 Million Capital Funding Agreement with the U.S. Department of Defense, in coordination with the Department of
Health and Human Services is incorporated by reference to Exhibit 10.2 to the Company's Quarterly Report on From 10-Q
for the period ended September 30, 2021, filed November 4, 2021.

Industrial Lease between Core5 at Laughman Farms Phase 1, LLC as Landlord and OraSure Technologies, Inc. as Tenant,
dated January 3, 2022 is incorporated by reference to Exhibit 10.30 to the Company's Annual Report on Form 10-K for
the year ended December 31, 2021.

Subsidiaries of the Company are incorporated by reference to Exhibit 21 to the Company’s Annual Report on Form 10-K
for the year ended December 31, 2013.

Consent of KPMG LLP.

Powers of Attorney.

Certification of Carrie Eglinton Manner. required by Rule 13a-14(a) or Rule 15d-14(a) under the Securities Exchange Act
of 1934, as amended.

Certification of Kenneth J. McGrath required by Rule 13a-14(a) or Rule 15d-14(a) under the Securities Exchange Act of
1934, as amended.

Certification of Carrie Eglinton Manner. required by Rule 13a-14(b) or Rule 15a-14(b) under the Securities Exchange Act
of 1934, as amended, and 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

Certification of Kenneth J. McGrath required by Rule 13a-14(b) or Rule 15a-14(b) under the Securities Exchange Act of
1934, as amended, and 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

101.INS

Inline XBRL Instance Document

101.SCH Inline XBRL Taxonomy Extension Schema Document

101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF

Inline XBRL Taxonomy Extension Definition Linkbase Document

101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document

101.PRE

Inline XBRL Taxonomy Extension Presentation Linkbase document

104

+
*

The cover page from the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, has been
formatted in Inline XBRL.

Filed herewith.

Management contract or compensatory plan or arrangement.

ITEM 16.

Form 10-K Summary.

None

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report
to be signed on its behalf by the undersigned, thereunto duly authorized, on March 3, 2023.

SIGNATURES

ORASURE TECHNOLOGIES, INC.

By:

/s/ Carrie Eglinton Manner
Carrie Eglinton Manner
President and Chief Executive Officer

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed on March 3, 2023, by the following
persons on behalf of the Registrant and in the capacities indicated.

SIGNATURE

TITLE

/s/ Carrie Eglinton Manner
Carrie Eglinton Manner

/s/ Kenneth J. McGrath
Kenneth J. McGrath

/s/ Michele Anthony

Michele Anthony

*MARA ASPINALL
Mara Aspinall

*JAMES A. DATIN
James A. Datin

*NANCY J. GAGLIANO
Nancy J. Gagliano

*LELIO MARMORA
Lelio Marmora

*DAVID J. SHULKIN, M.D.
David J. Shulkin, M.D.

*ANNE C. WHITAKER
Anne C. Whitaker

*By:

/s/Stefano Taucer
Stefano Taucer
(Attorney-in-Fact)

President, Chief Executive Officer and Director
(Principal Executive Officer)

Chief Financial Officer
(Principal Financial Officer)

Senior Vice President, Controller & Chief Accounting
Officer
(Principal Accounting Officer)

Director

[THIS PAGE INTENTIONALLY LEFT BLANK]

Index to Consolidated Financial Statements

Report of Independent Registered Public Accounting Firm (KPMG LLP, Philadelphia, PA, Auditor Firm ID:185) .................

Consolidated Balance Sheets ........................................................................................................................................................

Consolidated Statements of Operations.........................................................................................................................................

Consolidated Statements of Comprehensive Income (Loss).........................................................................................................

Consolidated Statements of Stockholders’ Equity .......................................................................................................................

Consolidated Statements of Cash Flows .......................................................................................................................................

Notes to the Consolidated Financial Statements ..........................................................................................................................

Page

F-2

F-4

F-5

F-6

F-7

F-8

F-9

F-1

Report of Independent Registered Public Accounting Firm

To the Stockholders and Board of Directors
OraSure Technologies, Inc.:

Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated balance sheets of OraSure Technologies, Inc. and subsidiaries (the Company) as of
December 31, 2022 and 2021, the related consolidated statements of operations, comprehensive income (loss), stockholders’ equity, and
cash flows for each of the years in the three-year period ended December 31, 2022, and the related notes (collectively, the consolidated
financial statements). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position
of the Company as of December 31, 2022 and 2021, and the results of its operations and its cash flows for each of the years in the three-
year period ended December 31, 2022, in conformity with U.S. generally accepted accounting principles.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB),
the Company’s internal control over financial reporting as of December 31, 2022, based on criteria established in Internal Control –
Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission, and our report dated
March 3, 2023 expressed an unqualified opinion on the effectiveness of the Company’s internal control over financial reporting.

Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion
on these consolidated financial statements based on our audits. We are a public accounting firm registered with the PCAOB and are
required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and
regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit
to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to
error or fraud. Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial
statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining,
on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included
evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation
of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.

Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements
that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are
material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments. The
communication of a critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a
whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or
on the accounts or disclosures to which it relates.

Evaluation of net realizable value adjustments to inventories for excess or obsolescence
As discussed in Notes 2 and 5 to the consolidated financial statements, the Company has inventories with a carrying value of
$96,232 thousand as of December 31, 2022. Inventories are stated at the lower of cost or net realizable value, with cost determined
on a first-in, first-out basis. The majority of the inventories are subject to expiration dating, which can be extended in certain
circumstances. The Company continually evaluates quantities on hand and the carrying value of inventories to determine the need
for net realizable value adjustments for excess and obsolete inventories, based primarily on prior experience with consideration
of expected changes in the business and estimated forecasts of product sales. The Company reserves for unidentified scrap or
spoilage based on historical write-off rates. The Company also considers items identified through specific identification
procedures in assessing the adequacy of the reserve.

We identified the evaluation of net realizable value adjustments to inventories for excess or obsolescence as a critical audit matter.
Evaluating the Company’s specific identification procedures, which included reviewing historical inventory consumption as
compared to inventory balances as of year-end and the resulting inventory consumption and ability to extend inventory expiration
dates, required a high degree of auditor judgment.

The following are the primary procedures we performed to address this critical audit matter. We evaluated the design and tested
the operating effectiveness of certain internal controls related to the Company’s process for determining net realizable value
adjustments for inventory excess or obsolescence, which included controls related to the review of the specific identification
procedures. For a selection of inventory items, we compared the Company’s historic estimates of net realizable value adjustments

F-2

for excess and obsolescence to the actual physical inventory disposals to evaluate the Company’s ability to accurately estimate
the net realizable value adjustments. In addition, we selected inventory items from the underlying data used in the Company’s
analysis and evaluated the Company’s determination of net realizable value adjustments for those items by: (1) testing historical
inventory consumption by independently recalculating the historical consumption and comparing it to the company determined
consumption, (2) comparing that consumption to inventory balances as of year-end, and (3) evaluating changes in the business
that could impact future inventory consumption, as applicable. We also selected inventory items from the underlying data used in
the Company’s analysis and evaluated the ability to extend the expiration dates by inspecting relevant supporting documentation.

/s/ KPMG LLP

We have served as the Company’s auditor since 2002.

Philadelphia, Pennsylvania
March 3, 2023

F-3

ORASURE TECHNOLOGIES, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(in thousands, except per share amounts)

December 31, 2022

December 31, 2021

ASSETS
Current Assets:

Cash and cash equivalents
Short-term investments
Accounts receivable, net of allowance for doubtful accounts of $2,365 and $3,418
Inventories
Prepaid expenses
Other current assets

Total current assets

Noncurrent Assets:

Property, plant and equipment, net
Operating right-of-use assets, net
Finance right-of-use assets, net
Intangible assets, net
Goodwill
Long-term investments
Other noncurrent assets

Total noncurrent assets

TOTAL ASSETS
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:
Accounts payable
Deferred revenue
Accrued expenses and other current liabilities
Finance lease liability
Operating lease liability
Acquisition-related contingent consideration obligation

Total current liabilities

Noncurrent Liabilities:

Finance lease liability
Operating lease liability
Acquisition-related contingent consideration obligation
Other noncurrent liabilities
Deferred income taxes

Total noncurrent liabilities

TOTAL LIABILITIES
Commitments and contingencies (Note 14)
STOCKHOLDERS' EQUITY

Preferred stock, par value $.000001, 25,000 shares authorized, none issued
Common stock, par value $.000001, 120,000 shares authorized, 72,734 and 72,069
shares issued and outstanding
Additional paid-in capital
Accumulated other comprehensive loss
Accumulated deficit

Total stockholders' equity

TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY

See accompanying notes to the consolidated financial statements.

F-4

83,980
26,867
70,797
96,232
6,273
41,569
325,718

59,413
10,399
1,293
11,694
35,104
—
1,087
118,990
444,708

39,349
2,273
25,762
1,179
1,764
65
70,392

503
9,101
99
581
408
10,692
81,084

—

—
520,446
(18,435)
(138,387)
363,624
444,708

116,762
36,279
45,323
53,138
7,939
39,865
299,306

73,435
9,056
2,493
14,343
40,279
17,009
5,069
161,684
460,990

28,024
2,936
33,778
939
2,181
206
68,064

1,952
7,202
354
651
2,234
12,393
80,457

—

—
511,063
(10,077)
(120,453)
380,533
460,990

ORASURE TECHNOLOGIES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)

NET REVENUES:

Products and services
Other

COST OF PRODUCTS AND SERVICES SOLD

Gross profit

OPERATING EXPENSES:

Research and development
Sales and marketing
General and administrative
Loss on impairments
Change in the estimated fair value of acquisition-related contingent
consideration

Operating loss
OTHER INCOME

Loss before income taxes
INCOME TAX EXPENSE
NET LOSS
LOSS PER SHARE:

BASIC
DILUTED

SHARES USED IN COMPUTING LOSS PER SHARE:

BASIC
DILUTED

$
$

For the years ended December 31,
2021

2020

2022

378,047
9,432
387,479
239,842
147,637

36,237
49,238
68,206
17,101

(188)
170,594
(22,957)
6,481
(16,476)
1,458
(17,934) $

226,897
6,777
233,674
116,074
117,600

34,170
44,751
50,328
—

(1,485)
127,764
(10,164)
872
(9,292)
13,706
(22,998) $

(0.25) $
(0.25) $

(0.32) $
(0.32) $

72,505
72,505

71,981
71,981

166,381
5,340
171,721
69,853
101,868

31,032
34,459
42,653
—

(1,099)
107,045
(5,177)
1,653
(3,524)
11,398
(14,922)

(0.22)
(0.22)

67,505
67,505

See accompanying notes to the consolidated financial statements.

F-5

ORASURE TECHNOLOGIES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(in thousands)

NET LOSS
OTHER COMPREHENSIVE LOSS
Currency translation adjustments
Unrealized gain (loss) on marketable securities

COMPREHENSIVE LOSS

For the years ended December 31,
2021

2020

2022

(17,934) $

(22,998) $

(14,922)

(8,572)
214
(26,292) $

(894)
(86)
(23,978) $

3,273
(234)
(11,883)

See accompanying notes to the consolidated financial statements.

F-6

ORASURE TECHNOLOGIES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
For the years ended December 31, 2022, 2021 and 2020
(in thousands)

Common Stock

Amount

Additional
Paid-in
Capital

61,731

— $

401,814

Accumulated
Other
Comprehensive
Loss
(12,136) $

Accumulated
Deficit

—

3,222

—

(2,088)

—

(82,533) $

—

Total
307,145

3,222

—

(2,088)

Balance at January 1, 2020
Common stock issued upon exercise

of options

Vesting of restricted stock and
performance stock units
Purchase and retirement of common
shares
Issuance of common stock in connection
with public offering, net of commissions
and expenses of $6,200
Stock-based compensation
Net loss
Currency translation adjustments
Unrealized loss on marketable securities
Balance at December 31, 2020
Common stock issued upon exercise

of options

Vesting of restricted stock and
performance stock units
Purchase and retirement of common
shares
Stock-based compensation
Net loss
Currency translation adjustments
Unrealized loss on marketable securities
Balance at December 31, 2021
Common stock issued upon exercise

of options

Vesting of restricted stock and
performance stock units
Purchase and retirement of common
shares
Stock-based compensation
Net loss
Currency translation adjustments
Unrealized gain on marketable securities
Balance at December 31, 2022

402

653

(248)

9,200
—
—
—
—
71,738

451

(153)
—
—
—
—
72,069

992

(329)
—
—
—
—
72,734

—
—
—
—
—
— $

95,036
7,139
—
—
—
505,123

—
—
—
3,273
(234)
(9,097) $

—
—
(14,922)
—
—
(97,455) $

95,036
7,139
(14,922)
3,273
(234)
398,571

—

246

—

—
—
—
—
—
— $

(2,113)
7,807
—
—
—
511,063

—

—
—
—
—
—
— $

(2,254)
11,622
—
—
—
520,446

—

—
—
—
(894)
(86)

—

—
—
(22,998)
—
—

(10,077) $ (120,453) $

—

—
—
—
(8,572)
214

—

—
—
(17,934)
—
—

(18,435) $ (138,387) $

246

—

(2,113)
7,807
(22,998)
(894)
(86)
380,533

—

(2,254)
11,622
(17,934)
(8,572)
214
363,624

See accompanying notes to the consolidated financial statements.

F-7

ORASURE TECHNOLOGIES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)

For the years ended December 31,

2022

2021

2020

(17,934) $

(22,998) $

(14,922)

OPERATING ACTIVITIES:
Net loss

Adjustments to reconcile net loss to net cash (used in) provided by operating
activities:

Stock-based compensation
Depreciation and amortization
Loss on impairments
Other non-cash amortization
Provision for doubtful accounts
Inventory reserve
Unrealized foreign currency (gain) loss
Interest expense on finance leases
Deferred income taxes
Loss on sale of fixed assets
Gain on sale of product line
Change in the estimated fair value of acquisition-related contingent
consideration
Payment of acquisition-related contingent consideration
Changes in assets and liabilities

Accounts receivable
Inventories
Prepaid expenses and other assets
Accounts payable
Deferred revenue
Accrued expenses and other liabilities

Net cash (used in) provided by operating activities

INVESTING ACTIVITIES:

Purchases of investments
Proceeds from maturities and redemptions of investments
Proceeds from sale of assets
Purchases of property and equipment
Purchase of property and equipment under government contracts
Proceeds from funding under government contract
Purchase of patent and product rights
Acquisition of businesses, net of cash acquired
Other investing activities

Net cash (used in) provided by investing activities

FINANCING ACTIVITIES:

Cash payments for lease liabilities
Issuance of common stock in connection with public offering, net
Proceeds from exercise of stock options
Payment of acquisition-related contingent consideration
Repurchase of common stock

Net cash (used in) provided by financing activities
EFFECT OF FOREIGN EXCHANGE RATE CHANGES ON CASH
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD
CASH AND CASH EQUIVALENTS, END OF PERIOD

11,622
15,308
17,101
228
(1,032)
(754)
(161)
94
(1,651)
729
—

(188)
—

(25,162)
(43,048)
(7,091)
3,963
(596)
1,370
(47,202)

(22,873)
47,415
121
(6,774)
(57,135)
60,331
—
—
—
21,085

(1,381)
—
15
(208)
(2,254)
(3,828)
(2,837)
(32,782)
116,762
83,980

7,807
11,658
—
837
(253)
6,731
(210)
82
1,026
—
—

(1,485)
(142)

(6,451)
(27,941)
(8,674)
3,234
(1,891)
3,288
(35,382)

(25,822)
67,925
—
(21,893)
(26,224)
531
—
—
(18)
(5,501)

(686)
—
246
(264)
(2,113)
(2,817)
(340)
(44,040)
160,802
116,762

7,139
9,387
—
327
941
736
269
72
(392)
114
(225)

(1,099)
(496)

(2,324)
(9,343)
(104)
7,379
1,051
7,297
5,807

(90,137)
107,718
—
(26,674)
—
—
(2,250)
(3,037)
351
(14,029)

(687)
95,036
3,222
(3,004)
(2,088)
92,479
830
85,087
75,715
160,802

See accompanying notes to the consolidated financial statements.

F-8

ORASURE TECHNOLOGIES, INC. AND SUBSIDIARIES

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

(in thousands, except per share amounts, unless otherwise indicated)

THE COMPANY:

The primary goal of OraSure Technologies, Inc. (“OraSure” or “the Company”) is to empower the global community to improve health
and wellness by providing access to accurate essential information through effortless tests, collection kits and services. OraSure's
business consists of two segments: our “Diagnostics” segment, and our “Molecular Solutions” segment.

The Company's Diagnostics business primarily consists of the development, manufacture, marketing and sale of simple, easy to use
diagnostic products and specimen collection devices using the Company's proprietary technologies, as well as other diagnostic products
including immunoassays and other in vitro diagnostic tests that are used on other specimen types. The Diagnostics business includes
tests for diseases including COVID-19, HIV and Hepatitis C that are performed on a rapid basis at the point of care, and tests for drugs
of abuse that are processed in a laboratory. These products are sold in the United States and internationally to various clinical
laboratories, hospitals, clinics, community-based organizations, and other public health organizations, distributors, government
agencies, physicians’ offices, and commercial and industrial entities. The Company's COVID-19 and HIV products are also sold in a
consumer-friendly format in the over-the-counter (“OTC”) market in the U.S. and, in the case of the HIV product, as a self-test to
individuals in a number of other countries. In 2022, after obtaining a CE mark, the Company launched the OraQuick® HIV Self-Test,
an oral swab in-home test for HIV-1 and HIV-2, in Europe, making it available in several European countries. Through the Company’s
Diagnostics business the Company is also developing and commercializing products that measure adherence to HIV medications
including pre-exposure prophylaxis ("PrEP").

The Company's Molecular Solutions business is operated by its wholly-owned subsidiaries, DNA Genotek Inc. ("DNAG"), Diversigen,
Inc. ("Diversigen"), and Novosanis NV ("Novosanis"). The Company's Molecular Solutions business sells its products and services
directly to its customers, primarily through its internal sales force in the U.S. domestic market, and in many international markets, also
through distributors. The Company's products primarily consist of collection kits and services used by clinical laboratories, direct-to-
consumer laboratories, researchers, pharmaceutical companies, and animal health service and product providers. Most of the Company's
Molecular Solutions revenues are derived from product sales to commercial customers and sales into the academic and research markets.
A significant portion of the Company's total sales is from repeat customers in both markets. Molecular Solutions customers span the
disease risk management, diagnostics, pharmaceutical, biotech, companion animal and environmental markets.

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES:

Principles of Consolidation and Basis of Presentation

The consolidated financial statements include the accounts of OraSure Technologies, Inc. (“OraSure”) and its wholly-owned
subsidiaries, DNAG, Diversigen, and Novosanis. All intercompany transactions and balances have been eliminated. References herein
to “we”, “us”, “our”, or the “Company” mean OraSure and its consolidated subsidiaries, unless otherwise indicated.

Use of Estimates

The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States
of America requires management to make estimates and assumptions about future events. These estimates and underlying assumptions
affect the amounts of assets and liabilities reported, disclosures about contingent assets and liabilities, and reported amounts of revenues
and expenses. Such estimates include the fair value of assets acquired and liabilities assumed for business combinations, the valuation
of accounts receivable and inventories and assumptions utilized in impairment testing for intangible assets and goodwill, as well as
estimates related to taxes, contingent consideration, and performance-based compensation expense. These estimates and assumptions
are based on management’s best estimates and judgment. Management evaluates its estimates and assumptions on an ongoing basis,
using historical experience and other factors, which management believes to be reasonable under the circumstances, including the current
economic environment. As future events and their effects cannot be determined with precision, actual results could differ significantly
from these estimates. Changes in those estimates resulting from continuing changes in the economic environment and other factors will
be reflected in the financial statements in those future periods.

Employee Retention Credit

In December 2021, the Company applied for the Employee Retention Credit for payroll taxes paid in the first and second quarters of
2021 as provided by the Coronavirus Aid, Relief and Economic Security Act. The amount due from the Internal Revenue Service of
$5,728 is recorded in other current assets in the Company's consolidated balance sheet as of December 31, 2022 and 2021. The amount

F-9

was received in 2023. The credit is reported in the Company's consolidated statement of operations, for the year ended December 31,
2021, within cost of products and services sold, research and development, sales and marketing and general and administrative costs in
the amounts of $2,536, $1,134, $924, and $1,134, respectively.

Supplemental Cash Flow Information

In 2022, 2021 and 2020, the Company paid income taxes of $9,446, $13,727 and $9,263, respectively.

The Company had account receivable write-offs of $2,296, $115, and $501 in 2022, 2021, and 2020, respectively.

As of December 31, 2022, 2021 and 2020, the Company had accruals for purchases of property and equipment of $227, $8,166 and
$802, respectively.

Investments

The Company considers all investments in debt securities to be available-for-sale securities. These securities are comprised of guaranteed
investment certificates and corporate bonds with purchased maturities greater than ninety days. Available-for-sale securities are carried
at fair value, based upon quoted market prices, with unrealized gains and losses, if any, reported in stockholders’ equity as a component
of accumulated other comprehensive loss.

The Company records an allowance for credit loss for the Company's available-for-sale securities when a decline in investment market
value is due to credit-related factors. When evaluating an investment for impairment, the Company reviews factors such as the severity
of the impairment, changes in underlying credit ratings, forecasted recovery, the Company’s intent to sell or the likelihood that it would
be required to sell the investment before its anticipated recovery in market value, and the probability that the scheduled cash payments
will continue to be made.

The following is a summary of the Company's available-for-sale securities as of December 31, 2022 and 2021:

December 31, 2022

Guaranteed investment certificates
Corporate bonds

Total available-for-sale securities
December 31, 2021

Guaranteed investment certificates
Corporate bonds

Total available-for-sale securities
At December 31, 2022, maturities of the Company's
available-for-sale securities were as follows:

Less than one year
Greater than one year

Fair Value of Financial Instruments

Amortized
Cost

Gross
Unrealized
Gains

Gross
Unrealized
Losses

Fair Value

22,109
4,978
27,087

33,249
20,473
53,722

— $
—
— $

— $

(220)
(220) $

— $

(434)
(434) $

22,109
4,758
26,867

33,249
20,039
53,288

27,087

$
— $

— $
— $

(220) $
— $

26,867
—

$
$

As of December 31, 2022 and 2021, the carrying values of cash and cash equivalents, accounts receivable, accounts payable, and accrued
expenses approximate their respective fair values based on their short-term nature.

Fair value measurements of all financial assets and liabilities that are being measured and reported on a fair value basis are required to
be classified and disclosed in one of the following three categories:

Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or
liabilities;

Level 2: Quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially
the full term of the asset or liability; and

F-10

Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and un-observable
(i.e., supported by little or no market activity).

All of the Company's available-for-sale debt securities are measured as Level 2 instruments as of December 31, 2022 and 2021. The
Company's guaranteed investment certificates are measured as Level 1 instruments as of December 31, 2022 and 2021.

Included in cash and cash equivalents at December 31, 2022 and 2021, was $1,730 and $1,160 invested in government money market
funds. These funds have investments in government securities and are measured as Level 1 instruments.

The Company offers a nonqualified deferred compensation plan for certain eligible employees and members of the Company's Board
of Directors. The assets of the plan are held in the name of the Company at a third-party financial institution. Separate accounts are
maintained for each participant to reflect the amounts deferred by the participant and all earnings and losses on those deferred amounts.
The assets of the plan are held in mutual funds. The fair value of the plan assets as of December 31, 2022 and 2021 was $747 and $1,763,
respectively, and was calculated using the quoted market prices of the assets as of those dates. All investments in the plan are classified
as trading securities and measured as Level 1 instruments. The fair value of plan assets is included in both current assets and other non-
current assets with the same amounts included in accrued expenses and other non-current liabilities in the accompanying consolidated
balance sheets.

As further discussed in Note 3, Business Combinations, the Company has identified the Company's contingent consideration obligations
as Level 3 liabilities due to significant inputs that are required to measure the fair value of these obligations.

Accounts Receivable

Accounts receivable have been reduced by an estimated allowance for amounts that may become uncollectible in the future. This
estimated allowance is based primarily on management’s evaluation of specific balances as they become past due, the financial condition
of the Company's customers and the Company's historical experience related to write-offs.

Inventories

Inventories are stated at the lower of cost or net realizable value, with cost determined on a first-in, first-out basis, and include the cost
of raw materials, labor and overhead. The majority of the Company's inventories are subject to expiration dating, which can be extended
in certain circumstances. The Company continually evaluates quantities on hand and the carrying value of the Company's inventories to
determine the need for net realizable value adjustments, based primarily on prior experience with consideration of expected changes in
the business and estimated forecasts of product sales. The Company reserves for unidentified scrap or spoilage based on historical write-
off rates. The Company also considers items identified through specific identification procedures in assessing the adequacy of the
Company's reserve. Although the Company makes every effort to ensure the accuracy of its forecasts of future product demand, any
significant unanticipated changes in demand could have a significant impact on the carrying value of its inventories and reported
operating results

Property, Plant and Equipment

Property, plant and equipment are stated at cost. Additions or improvements are capitalized, while repairs and maintenance are charged
to expense. Depreciation and amortization are provided using the straight-line method over the estimated useful lives of the related
assets. Buildings are typically depreciated over twenty years, while computer equipment and software, machinery and equipment, and
furniture and fixtures are depreciated over two to ten years. Building improvements are amortized over their estimated useful lives.
When assets are sold, retired, or discarded, the related property amounts are relieved from the accounts, and any gain or loss is recorded
in the consolidated statements of operations.

Intangible Assets

Intangible assets consist of customer relationships, patents and product rights, acquired technology and trade names. Patents and product
rights consist of costs associated with the acquisition of patents, licenses and product distribution rights. Intangible assets are amortized
using the straight-line method over their estimated useful lives of five to fifteen years.

F-11

Impairment of Long-Lived Assets

Long-lived assets, which include property and equipment and definite-lived intangible assets, are tested for recoverability whenever
events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. The Company
assesses the recoverability of the Company's long-lived assets by determining whether the carrying value of such assets can be recovered
through the sum of the undiscounted future cash flows generated from the use and eventual disposition of the asset. If indicators of
impairment exist, the Company measures the amount of such impairment by comparing the carrying value of the assets to the fair value
of these assets, which is generally determined based on the present value of the expected future cash flows associated with the use of
the assets. Expected future cash flows reflect the Company's assumptions about selling prices, volumes, costs and market conditions
over a reasonable period of time. See Note 6 for discussion of impairments recorded in 2022.

Goodwill

Goodwill represents the excess of the purchase price over the fair value of the net tangible and identifiable intangible assets acquired.
Goodwill is not amortized but rather is tested annually for impairment or more frequently if the Company believes that indicators of
impairment exist. Current generally accepted accounting principles permit the Company to make a qualitative evaluation about the
likelihood of goodwill impairment. If the Company concludes that it is more likely than not that the carrying value of a reporting unit is
greater than its fair value, then the Company would be required to recognize an impairment charge for the amount by which the carrying
amount exceeds the reporting unit’s fair value, provided the impairment charge does not exceed the total amount of goodwill allocated
to the reporting unit.

The Company performs an annual goodwill impairment assessment as of July 31 each year. Historically this involved a qualitative
analysis that resulted in a conclusion that it was more likely than not that the fair value of the Company's reporting units is greater than
their carrying value.

A more frequent evaluation is performed if an event occurs or circumstances change between annual tests that could more likely than
not reduce the fair value of a reporting unit below its carrying amount.

Revenue

Product sales. Revenue from product sales is recognized upon transfer of control of a product to a customer based on an amount that
reflects the consideration the Company is entitled to, net of allowances for any discounts or rebates.

The Company generally does not grant product return rights to the Company's customers, except for warranty returns and return rights
on sales of the Company's OraQuick® In-Home HIV test to the retail trade, and InteliSwab® products to the retail trade and certain
customers.

Historically, returns arising from warranty issues have been infrequent and immaterial. Accordingly, the Company expenses warranty
returns as incurred.

The Company records shipping and handling charges billed to the Company's customers as product revenue and the related expense as
cost of products sold.

Service revenues. Service revenues represent microbiome laboratory testing and analytical services. The Company recognizes revenues
when the Company satisfies its performance obligations for services rendered.

Arrangements with multiple-performance obligations. In arrangements involving more than one performance obligation, which largely
applies to the Company's service revenue stream, each required performance obligation is evaluated to determine whether it qualifies as
a distinct performance obligation based on whether (i) the customer can benefit from the good or service either on its own or together
with other resources that are readily available and (ii) the good or services is separately identifiable from other promises in the contract.
The consideration under the arrangement is then allocated to each separate distinct performance obligation based on their respective
relative stand-alone selling price. The estimated selling price of each deliverable is determined using an observable cost plus margin
approach. The consideration allocated to each distinct performance obligation is recognized as revenue when control is transferred for
the related goods or services or when the performance obligation has been satisfied.

Other revenues. Other revenues consist primarily of royalty income and funding from grants of research and development efforts. For
the year ended December 31, 2021, other revenue also included cost reimbursements under a charitable support agreement which ended
in June 2021. Royalties from licensees are based on third-party sales of licensed products and are recorded when the related third-party

F-12

product sale occurs. Research and development grant revenue is recognized pursuant to International Accounting Standard 20,
Accounting for Government Grants and Disclosure of Government Assistance ("IAS 20"). The expenses are recorded in research and
development expense and the reimbursements are recorded in other revenue. Funding of research and development efforts and charitable
support reimbursements are recorded as the activities are performed in accordance with the respective agreements.

Deferred Revenue. The Company records deferred revenue when funds are received prior to the recognition of the associated revenue.
Deferred revenue as of December 31, 2022 and 2021 included customer prepayments of $1,533 and $1,843, respectively. Deferred
revenue as of December 31, 2022 and 2021 also included $740 and $1,093, respectively, associated with a long-term contract that has
variable pricing based on volume. The average price over the life of contract was determined based on expected revenues and revenue
is recognized at that rate when the product is delivered to the customer.

Financing and Payment. The Company's payment terms vary by the type and location of our customer and products or services offered.
Payment terms differ by jurisdiction and customer but payment is generally required in a term ranging from 30 to 120 days from date
of shipment or satisfaction of the performance obligation.

For certain products or services and customer types, the Company may require payment before the products are delivered or services
are rendered to the customer.

Practical expedients and exemptions. Taxes assessed by governmental authorities, such as sales or value-added taxes, are excluded
from product revenues.

Sales commissions are expensed when incurred if the amortization period is one year or less. These costs are recorded in sales and
marketing expense in the consolidated statements of operations. If the amortization period exceeds one year, the Company defers the
cost of the commission and expenses it over the life of the related sales contract.

Revenues by product. The following table represents total net revenues by product line:

COVID-19
Genomics
HIV
HCV
Risk assessment testing
Microbiome
Laboratory services
Other product and service revenues
Net product and services revenues
Royalty income
Other non-product revenues
Other revenues
Net revenues

2022

$ 243,325 $
54,335
38,812
13,369
10,269
7,503
7,296
3,138

Years ended December 31,
2021
76,874 $
63,350
42,144
11,783
9,678
7,944
11,840
3,284

2020
50,927
36,878
44,224
8,448
9,194
5,474
8,746
2,490
$ 378,047 $ 226,897 $ 166,381
3,432
1,908
5,340
$ 387,479 $ 233,674 $ 171,721

4,420
2,357
6,777

2,683
6,749
9,432

Revenues by geographic area. The following table represents total net revenues by geographic area, based on the location of the
customer:

United States
Europe
Other regions

2022

Years ended December 31,
2021
$ 350,206 $ 188,383 $ 130,835
12,068
28,818
$ 387,479 $ 233,674 $ 171,721

13,799
31,492

11,536
25,737

2020

Customer and Vendor Concentrations. The Company had one customer that accounted for more than 57% of the Company's
consolidated accounts receivable as of December 31, 2022 and none as of December 31, 2021. The same customer accounted for
approximately 58% of the Company's consolidated revenues for the year ended December 31, 2022. The Company had no customers
that accounted for more than 10% of the Company's consolidated net revenues for the years ended December 31, 2021 and 2020.

F-13

The Company currently purchases certain products and critical components of the Company's products from sole-supply vendors. If
these vendors are unable or unwilling to supply the required components and products, the Company could be subject to increased costs
and substantial delays in the delivery of the Company's products to the Company's customers. Third-party suppliers also manufacture
certain products. The Company's inability to have a timely supply of any of these components and products could have a material adverse
effect on the Company's business, as well as the Company's financial condition and results of operations.

The Company’s Intercept i2® he collection device is manufactured and supplied under a long-term agreement with Thermo Fisher, the
sole-source supplier for these products. DNAG has three long-term contract manufacturing relationships to supply virtually all of its
products, including the Oragene® product line. Many of the raw materials and components used in these products are also purchased
from third parties, some of which are purchased from a single source supplier. The Company is actively seeking to qualify other suppliers
that can manufacture and supply the raw materials and components for the DNAG products.

Business Combinations and Contingent Consideration

Acquired businesses are accounted for using the acquisition method of accounting, which requires that the purchase price be allocated
to the net assets acquired at their respective fair values. Any excess of the purchase price over the estimated fair values of the net assets
acquired is recorded as goodwill. Amounts allocated to contingent consideration are recorded to the balance sheet at the date of
acquisition based on their relative fair values. The purchase price allocation requires the Company to make significant estimates and
assumptions, especially at the acquisition date, with respect to intangible assets. Although the Company believes the assumptions and
estimates it has made are reasonable, they are based in part on historical experience and information obtained from the management of
the acquired companies and are inherently uncertain.

The Company accounts for contingent consideration in accordance with applicable guidance provided within the business combination
accounting standard. As part of the Company's consideration for the recent acquisitions, the Company is contractually obligated to pay
certain consideration resulting from the outcome of future events. Therefore, the Company is required to update the Company's
underlying assumptions each reporting period, based on new developments, and record such contingent consideration liabilities at fair
value until the contingency is resolved. Changes in the fair value of the contingent consideration liabilities are recognized each reporting
period and included in the Company's consolidated statements of operations. The Company's estimates of fair value are based on
assumptions the Company believes to be reasonable, but the assumptions are uncertain and involve significant judgment by management.
Updates to these assumptions could have a significant impact on the Company's results of operations in any given period and any updates
to the fair value of the contingent consideration could differ materially from the previous estimates.

Examples of critical estimates used in valuing certain intangible assets and contingent consideration include:

•

future expected cash flows from sales and acquired developed technologies;

the acquired company's trade name and customer relationships as well as assumptions about the period of time the
acquired trade name and customer relationships will continue to be used in the combined company's portfolio;

the probability of meeting the future events; and

discount rates used to determine the present value of estimated future cash flows.

These estimates are inherently uncertain and unpredictable, and if different estimates were used the purchase price for the acquisition
could be allocated to the acquired assets and liabilities differently from the allocation that the Company has made. In addition,
unanticipated events and circumstances may occur, which may affect the accuracy or validity of such estimates, and if such events occur
the Company may be required to record a charge against the value ascribed to an acquired asset or an increase in the amounts recorded
for assumed liabilities.

Research and Development

Research and development expenses consist of costs incurred in performing research and development activities, including salaries and
benefits, facilities expenses, overhead expenses, clinical trial and related clinical manufacturing expenses, contract services and other
outside expenses. Research and development costs are charged to expense as incurred.

F-14

Advertising Expenses

Advertising costs are charged to expense as incurred. During 2022, 2021, and 2020, the Company incurred $4,849, $5,103, and $1,126,
respectively, in advertising expenses.

Stock-Based Compensation

The Company accounts for stock-based compensation to employees and directors using the fair value method. The Company recognizes
compensation expense for stock option and restricted stock awards issued to employees and directors on a straight-line basis over the
requisite service period of the award. The Company recognizes compensation expense related to performance-based restricted stock
units based on assumptions as to what percentage of each performance target will be achieved. The Company evaluates these target
assumptions on a quarterly basis and adjusts compensation expense related to these awards, as appropriate. To satisfy the exercise of
options, issuance of restricted stock, or redemption of performance-based restricted stock units, the Company issues new shares rather
than purchase shares in the open market.

Income Taxes

The Company follows the asset and liability method for accounting for income taxes. Under this method, deferred tax assets and
liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of
existing assets and liabilities and the respective tax basis of assets and liabilities, as well as operating loss and credit carryforwards.
Deferred tax assets and liabilities are measured using enacted tax rates for the respective taxing jurisdiction that are expected to apply
to taxable income in the years in which those temporary differences and operating loss and credit carryforwards are expected to be
recovered, settled or utilized. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the
period that includes the enactment date.

The Company assesses the realizability of the Company's net deferred tax assets on a quarterly basis. If, after considering all relevant
positive and negative evidence, it is more likely than not that some portion or all of the net deferred tax assets will not be realized, the
Company reduces its net deferred tax assets by a valuation allowance. The realization of the net deferred tax assets is dependent on
several factors, including the generation of sufficient taxable income prior to the expiration of the Company's net operating loss
carryforwards.

Foreign Currency Translation

The assets and liabilities of the Company's foreign operations are translated into U.S. dollars at current exchange rates as of the balance
sheet date, and revenues and expenses are translated at average exchange rates for the period. Resulting translation adjustments are
reflected in accumulated other comprehensive loss, which is a separate component of stockholders’ equity.

Transaction gains and losses resulting from exchange rate changes on transactions denominated in currencies other than functional
currency are included in the Company's consolidated statements of operations in the period in which the change occurs. Net foreign
exchange gains (losses) resulting from foreign currency transactions that are included in other income in the Company's consolidated
statements of operations were $1,553, $(667), and $(337) for the years ended December 31, 2022, 2021, and 2020, respectively.

Earnings (Loss) Per Share

Basic earnings (loss) per share is computed by dividing net income (loss) by the weighted-average number of shares of common stock
outstanding during the period. Diluted earnings (loss) per share is computed in a manner similar to basic earnings (loss) per share except
that the weighted-average number of shares outstanding is increased to include incremental shares from the assumed vesting or exercise
of dilutive securities, such as common stock options, unvested restricted stock or performance stock units, unless the impact is anti-
dilutive. The number of incremental shares is calculated by assuming that outstanding stock options were exercised and unvested
restricted shares and performance stock units were vested, and the proceeds from such exercises or vesting were used to acquire shares
of common stock at the average market price during the reporting period. Basic and dilutive computations of net loss per share are the
same in periods in which a net loss exists as the dilutive effects of excluded items would be anti-dilutive.

For the years ended December 31, 2022, 2021, and 2020 outstanding common stock options, unvested restricted stock, and unvested
performance stock units representing 436, 769, and 984 shares, respectively, were excluded from the computation of diluted loss per
share.

F-15

Accumulated Other Comprehensive Loss

The Company classifies items of other comprehensive income (loss) by their nature and discloses the accumulated balance of other
comprehensive loss separately from accumulated deficit and additional paid-in capital in the stockholders’ equity section of the
Company's consolidated balance sheets.

The Company has defined the Canadian dollar as the functional currency of the Company's Canadian subsidiary, DNAG, and the
Company has defined the Euro as the functional currency of the Company's Belgian subsidiary, Novosanis. The results of operations
are translated into U.S. dollars, which is the reporting currency of the Company. Accumulated other comprehensive loss at December 31,
2022 consists of $18,215 of currency translation adjustments and $220 of net unrealized losses on marketable securities. Accumulated
other comprehensive loss at December 31, 2021 consists of $9,643 of currency translation adjustments and $434 of net unrealized losses
on marketable securities, which represents the fair market value adjustment for the Company's investments portfolio.

Recent Accounting Pronouncements

In March 2020, the FASB issued Accounting Standards Update (“ASU”) No. 2020-04, Reference Rate Reform (Topic 848) Facilitation
of the Effects of Reference Rate Reform on Financial Reporting. The purpose of this update is to provide optional guidance for a limited
time to ease the potential burden in accounting for (or recognizing the effects of) reference rate reform on financial reporting. The
amendments provide optional expedients and exceptions for applying GAAP to contracts, hedging relationships, and other transactions
affected by reference rate reform if certain criteria are met. The amendments in this ASU were effective upon issuance and could be
applied prospectively through December 31, 2022. The FASB issued an amendment, ASU 2022-06, Deferral of the Sunset Date of Topic
848, in December 2022, which, extends the date for prospective application to December 31, 2024. Management has evaluated this ASU
and concluded that it will not have a material impact on the Company's Consolidated Financial Statements.

Reclassifications

Certain prior period amounts have been reclassified to conform to current year presentation. See Note 4 for discussion of the
reclassification related to the U.S. Department of Defense contract.

BUSINESS COMBINATIONS

UrSure

On July 22, 2020, the Company acquired all of the outstanding stock of UrSure, Inc. (“UrSure”), pursuant to the terms of a merger
agreement. The initial aggregate purchase price of this transaction was $3,000, adjusted for certain transaction costs, indebtedness, and
holdback amounts, and was funded with cash on hand. A portion of the purchase price was deposited into an escrow account for a
limited period after closing, pursuant to indemnification obligations under the merger agreement.

During the year ended December 31, 2020, the Company incurred a total of $393 of acquisition related costs, including accounting,
legal, and other professional fees, all of which were expensed and reported as a component of general and administrative expense in the
consolidated statement of operations for the year ended December 31, 2020.

Pursuant to the Company's acquisition agreement, the Company was to pay up to an additional $28,000 of contingent consideration over
the three years following the acquisition date based on the achievement of certain performance criteria as defined under the agreements,
including generating certain revenue dollars, and the achievement of certain clinical milestones associated with the development of
certain new technology. The Company, with the assistance of an independent valuation specialist, determined the estimated acquisition-
date fair value of the acquisition-related contingent consideration of $3,440. The fair value was determined using a probability-weighted
model based on the Company's assessment of the likelihood that the benchmarks will be achieved. The probability-weighted payments
were then discounted using a discount rate based on an internal rate of return analysis using the probability-weighted cash flows. The
fair value measurement was based on significant inputs, including the likelihood of the achievement of clinical milestones and revenue
forecasts, not observable in the market and thus represents a Level 3 measurement within the fair value hierarchy. As of December 31,
2022, it is not likely the Company will be required to make a material payment.

F-16

The following table represents the change in contingent consideration:

Estimated fair value of contingent consideration as of acquisition date
Change in fair value during the period
Balance as of December 31, 2020
Payments made during the period
Change in fair value during the period
Balance as of December 31, 2021
Payments made during the period
Change in fair value during the period
Balance as of December 31, 2022

3,440
(989)
2,451
(406)
(1,485)
560
(208)
(188)
164

The change in fair value during the years ended December 31, 2022, 2021 and 2020 is a result of delays in achieving certain product
development milestones and a decrease in associated revenue forecasts as result of these delays.

Revenues from UrSure primarily consist of grant money received to fund the development of certain new technology. Effective as of
July 22, 2020, the financial results of UrSure are included in the Company's Diagnostics segment.

The Company finalized its valuation of the assets acquired and liabilities assumed. The total consideration of $3,037 was allocated to
assets acquired and liabilities assumed as of the acquisition date as follows:

Assets Acquired
Accounts receivable
Other current assets
Other assets
Intangibles
Goodwill

Total assets acquired

Liabilities Assumed
Current liabilities
Deferred tax liability

Total liabilities assumed

Net Assets Acquired
Fair value of contingent consideration
Net Cash Paid (net of cash acquired of $111)

285
24
6
3,600
3,586
7,501

335
689
1,024
6,477
(3,440)
3,037

The purchase price was allocated to the tangible assets and identifiable intangible assets acquired and liabilities assumed based on their
acquisition-date estimate fair values. The identifiable intangible assets principally included developed technology, which is subject to
amortization on a straight-line basis and is being amortized over a ten year estimated useful life.

The Company, with the assistance of an independent valuation specialist, assessed the fair value of the assets of UrSure. The income
approach was used to value the acquired intangibles and the fair value measurements were primarily based on significant inputs that are
not observable in the market and are considered Level 3 fair value measurements. The income approach estimates fair value for an asset
based on the present value of cash flows projected to be generated by the asset. Projected cash flows are discounted at a required rate
of return that reflects the relative risk of achieving the cash flows and the time value of money.

The useful lives of the intangible assets were estimated based on the expected future economic benefit of the assets and are being
amortized over the estimated useful life in proportion to the economic benefits consumed using the straight-line method.

The amortization of intangible assets is not deductible for income tax purposes.

Goodwill is calculated as the difference between the acquisition date fair value of the consideration transferred and the fair value of the
net assets acquired, and represents the future economic benefits that the Company expects to achieve as a result of the acquisition. The
Company believes the goodwill related to the acquisition was a result of gaining a complementary product offering that will enable the
Company to leverage those products with existing and new customers. The goodwill is not deductible for income tax purposes. All of
the goodwill identified above has been allocated to the Company's Diagnostics segment.

F-17

GOVERNMENT CAPITAL CONTRACTS:

In September 2021, the Company entered into an agreement for $109,000 in funding from the U.S. Department of Defense (the “DOD”),
in coordination with the Department of Health and Human Services, to build additional manufacturing capacity in the United States for
the Company's InteliSwab® COVID-19 Rapid Tests as part of the nation’s pandemic preparedness plan. Funding will be paid to the
Company based on achievement of milestones expected to occur through December 2023 for the design, acquisition, installation,
qualification and acceptance of the manufacturing equipment, as set forth in the agreement. In accordance with the milestone payment
schedule, 15% of the total will not be funded until the completion of the final validation testing, which is scheduled to occur in late
2023. The Company began making payments to vendors for the capital project during the fourth quarter of 2021. The Company began
receiving funds from the DOD in January 2022 and has received $60,331 as of the date of this report. The remaining $48,669 is expected
to be collected within the next year.

Activity for these capital contracts is accounted for pursuant to IAS 20, Accounting for Government Grants and Disclosure of
Government Assistance. Funding received in relation to capital-related costs incurred for government contracts is recorded as a reduction
to the cost of property, plant and equipment and reflected within investing activities in the consolidated statements of cash flows; and
associated unpaid liabilities and government proceeds receivable are considered non-cash changes in such balances within the operating
section of the consolidated statements of cash flows. Property, plant and equipment in the amount of $14,729 that was recorded on the
Company's consolidated balance sheet as of December 31, 2021 was reclassified in 2022 as the assets were allocated to the DOD build
out. The consolidated balance sheet as of December 31, 2021 has been updated to reflect a reduction of $14,729 in property, plant and
equipment and an increase in other current assets of $10,875 and other noncurrent assets of $3,854 for amounts due from DOD. The
respective investing activities on the consolidated cash flows for the year ended December 31, 2021 have also been reclassified.

The DOD also reimburses the Company for certain engineering consulting costs. These expenses are reflected in research and
development expenses as incurred with the corresponding amount presented in other income. For the year ended December 31, 2022,
$1,422 was recorded in research and development expenses and other income. Amounts earned in excess of the Company's expected
costs for the project for project management are recognized straight-line in other income over the term of the government contract. The
Company recognized $2,246 and $561 of such income, which is reported as other income in the Company's consolidated statement of
operations for the year ended December 31, 2022 and 2021, respectively.

Additionally, during 2021, the Company received $531 in funding from the Commonwealth of Pennsylvania, acting through the
Department of Community and Economic Development, for the purchase of machinery and equipment as part of an expansion of
manufacturing operations in Pennsylvania. All related purchases were completed in 2021.

The balances corresponding to government contracts included in the Company's consolidated balance sheet are as follows:

Other current assets:
Billed receivables
Unbilled receivables
Total other current assets

Other non-current assets
Accrued expenses and other current liabilities

December 31,
2022

December 31,
2021

— $

27,013
27,013
—
(318) $

9,913
20,591
30,504
3,854
(8,103)

The activity corresponding to the government contracts included in the Company's consolidated statements of cashflows is as follows:

Cost of assets, cumulative
Reduction for funding earned to date, not yet received
Reduction for funding received to date

Total property, plant and equipment, net

December 31,
2022

December 31,
2021

83,359 $
(22,497)
(60,862)

— $

26,224
(25,693)
(531)
—

F-18

INVENTORIES:

Raw materials
Work in process
Finished goods

December 31,

2022

2021

42,445 $
2,335
51,452
96,232 $

33,168
2,252
17,718
53,138

During 2022, 2021, and 2020, the Company recorded adjustments to inventory which had a cost of $15,618, $13,400, and $2,564,
respectively. The adjustments in 2021 included a write-off of $3,008 of COVID-19 antibody inventory, which the Company does not
believe the Company can sell as a result of the decision to no longer pursue an EUA for the ELISA antibody test. Additionally, a
significant portion of the Company's 2022 and 2021 adjustments were related to production and tech-transfer issues associated with the
Company's COVID-19 rapid test.

PROPERTY, PLANT AND EQUIPMENT:

Land
Buildings and improvements
Machinery and equipment
Computer equipment and software
Furniture and fixtures
Construction in progress

Less accumulated depreciation

December 31,

2022

2021

1,118 $
35,582
60,725
16,681
4,064
11,124
129,294
(69,881)
59,413 $

1,118
35,420
57,919
14,700
4,228
21,207
134,592
(61,157)
73,435

During the year ended December 31, 2022, management determined several manufacturing lines and associated supporting assets will
not be utilized due to changes in forecasted demand for the products the lines are intended to produce. As a result of this decision, the
Company determined that the carrying values of the equipment are not recoverable and recorded aggregate pre-tax asset impairment
charges of $8,585 and $4,912 to the Molecular Solutions and Diagnostics segments, respectively, to write the assets down to their
estimated fair values. This resulted in the assets being fully impaired. This charge is reported within loss on impairments in the
consolidated statement of operations.

The Company estimated the fair value of the impaired long-lived assets using a market approach, which required the Company to
estimate the value that would be received for the equipment in the most advantageous market for that equipment in an orderly transaction
between market participants. Due to the extremely specialized nature of the manufacturing equipment and various market data points,
the estimated fair value was not significant. The Company's fair value estimates were representative of Level 3 measurements within
the fair value hierarchy due to the significant level of estimation involved and the lack of transparency as to the inputs used.

Depreciation expense was $11,740, $7,498, and $5,514 for 2022, 2021, and 2020, respectively. See Note 4 for discussion of prior year
reclassification.

7. GOODWILL AND OTHER INTANGIBLE ASSETS:

The following table represents total goodwill by operating segment:

Diagnostics
Molecular Solutions

December 31,

2022

2021

— $

35,104
35,104 $

3,604
36,675
40,279

F-19

The changes in goodwill are as follows:

Balance as of January 1
Impairment
Purchase price adjustment
Change related to foreign currency translation
Balance as of December 31

December 31,

2022

2021

40,279 $
(3,604)
—
(1,571)
35,104 $

40,351
—
18
(90)
40,279

During the second quarter of 2022, the Company determined that a triggering event occurred in relation to the depressed market price
of the Company's common stock and corresponding decline in the Company's market capitalization. As a result, the Company performed
an interim quantitative goodwill impairment test and concluded that the carrying value of the Company's Diagnostics reporting unit
exceeded its estimated fair value and the goodwill balance for that segment was fully impaired. The Company recognized a pre-tax
impairment charge of $3,604 during the year ended December 31, 2022, which is reported in loss on impairments in the Company's
consolidated statement of operations. The Company's quantitative goodwill impairment test concluded that the carrying value of the
Company's Molecular Solutions reporting unit exceeded its estimated fair value and no impairment of the related goodwill exists.

Intangible assets consist of the following:

Customer relationships
Patents and product rights
Developed technology
Tradename

Amortization
Period (Years)

Gross

10 $
5
7-10
5-15

14,286
7,620
15,478
5,387
42,771

Amortization
Period (Years)

Gross

10 $
5
7-10
5-15

15,016
7,785
16,293
5,661
44,755

December 31, 2022
Accumulated
Amortization
$

(11,011) $
(6,615)
(9,940)
(3,511)
(31,077) $

December 31, 2021
Accumulated
Amortization
$

(11,205) $
(6,241)
(9,725)
(3,241)
(30,412) $

Net

3,275
1,005
5,538
1,876
11,694

Net

3,811
1,544
6,568
2,420
14,343

Amortization expense for 2022, 2021, and 2020 was $2,269, $3,260, and $3,246, respectively.

Amortization expense for each of the five succeeding fiscal years and beyond is estimated as follows:

2023
2024
2025
2026
2027
Beyond

2,221
2,183
1,947
1,591
1,520
2,232
11,694

F-20

8. ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES:

Payroll and related benefits
Commitment to purchase under government contract
Professional fees
Sales tax payable
Other

December 31,

2022

2021

14,103
—
4,685
1,519
5,455
25,762

15,570
8,103
3,335
2,227
4,543
33,778

LEASES:

The Company determines whether an arrangement is a lease at inception. The Company has operating and finance leases for corporate
offices, warehouse space and equipment (including vehicles). As of December 31, 2022, the Company is the lessee in all agreements.
The Company's leases have remaining lease terms of 1 to 10 years, some of which include options to extend the leases based on agreed
upon terms, and some of which include options to terminate the leases within 1 year. The Company presents the operating right-of-use
asset amortization and the change in operating lease liabilities on the same line item, other non-cash amortization on the statement of
cash flows.

As most of the Company's leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the
information available at the lease commencement date in determining the present value of lease payments.

The Company has lease agreements that contain both lease and non-lease components (e.g., common-area maintenance). For these
agreements, the Company accounts for lease components separately from non-lease components. During 2021, the Company entered
into various purchase agreements for the Company's Molecular Solutions business which include a finance lease component for the use
of specialized molds made and used by the vendor for purposes of manufacturing the goods to be purchased. The Company recorded
an aggregate ROU asset and offsetting lease liability of $2,074 upon commencement of these contracts. The consideration to be paid
under the agreements is variable based on the amounts purchased with a fixed amount charged if specified purchase minimums are not
met. Only the fixed amount has been included in the measurement of the finance right-of-use asset and lease liability, and the variable
costs are recognized as purchases are made within cost of products and services sold in the Company's consolidated statements of
operations. The consideration for the contract has been allocated between the lease and non-lease components based on their relative
estimated stand-alone selling prices.

The components of lease expense are as follows:

Operating lease cost
Variable and short-term lease cost
Finance lease cost:

Amortization of right-of use assets
Interest on lease liabilities
Total finance lease cost

Total lease cost

Years ended December 31,
2021

2020

2022

2,910 $
521

1,299
94
1,393
4,824 $

2,226 $
201

900
82
982
3,409 $

1,291
—

627
72
699
1,990

Supplemental cash flow information related to leases is as follows:

F-21

Years ended December 31,
2021

2020

2022

Cash paid for amounts included in the measurement of
lease liabilities:

Operating cash flows from operating leases
Operating cash flows from financing leases
Financing cash flows from financing leases

2,209 $
94
1,381

3,733 $
82
686

Non-cash activity:

Right-of-use assets obtained in exchange for
operating lease obligations
Right-of-use assets obtained in exchange for finance
lease obligations

3,963

117

6,480

2,074

Supplemental balance sheet information related to leases is as follows:

Operating Leases
Right-of-use assets
Lease liabilities:

Current lease liabilities
Non-current lease liabilities
Total operating lease liabilities

Finance Leases
Right-of-use assets
Lease liabilities:

Current lease liabilities
Non-current lease liabilities
Total finance lease liabilities

December 31,

2022

2021

10,399

1,764
9,101
10,865

1,293

1,179
503
1,682

1,280
72
687

498

9,056

2,181
7,202
9,383

2,493

939
1,952
2,891

Weighted Average Remaining Lease Term
Weighted-average remaining lease term—operating leases
Weighted-average remaining lease term—finance leases

6.24 years
1.33 years

5.26 years
2.21 years

Weighted Average Discount Rate
Weighted-average discount rate—operating leases
Weighted-average discount rate—finance leases

4.06%
3.44%

3.90%
3.57%

As of December 31, 2022, minimum lease payments by period are expected to be as follows:

2023
2024
2025
2026
2027
Thereafter
Total minimum lease payments
Less: imputed interest
Present value of lease liabilities

Finance

Operating

1,216
505
20
12
—
—
1,753
(71)
1,682

1,898
2,311
1,928
1,710
1,544
3,083
12,474
(1,609)
10,865

F-22

10.

INCOME TAXES:

Income (loss) before income tax expense consists of the following:

United States
Foreign

The components of income tax expense (benefit) are as follows:

Current

Federal
State
Foreign

Deferred
Federal
State
Foreign

Increase (decrease) in valuation allowance

Total income tax expense

2022

Years Ended December 31,
2021
(60,500) $
51,208
(9,292) $

(7,912) $
(8,564)
(16,476) $

2020
(47,995)
44,471
(3,524)

Years Ended December 31,
2021

2020

2022

— $
955
2,154
3,109

(2,250)
(633)
(2,617)
(5,500)
3,849
(1,651)
1,458

— $
163
12,517
12,680

(10,318)
(965)
(151)
(11,434)
12,460
1,026
13,706

—
(106)
11,896
11,790

(20,946)
(1,053)
(410)
(22,409)
22,017
(392)
11,398

For the years ended December 31, 2022, 2021, and 2020 the Company recorded foreign income tax expense of $503, $13,543, and
$12,185, respectively. The Company's 2022 income tax expense is comprised of $1,703 of Canadian withholding taxes paid on the
repatriation of Canadian earnings which occurred in the first quarter of 2022, $955 of U.S. state income taxes, and a foreign income tax
benefit of $1,200 associated with the Company's Canadian subsidiary. The Company's 2021 income tax expense is comprised of U.S.
state income taxes of $163 and foreign tax expense associated with the Company's Canadian subsidiary of $13,543. The Company's
2020 income tax expense is comprised of a U.S. state income tax benefit of a $794 and foreign tax expense associated with the Company's
Canadian subsidiary of $12,192.

A reconciliation of the statutory United States federal income tax rate to the Company's effective tax rate for each of the years ended
December 31, 2022, 2021, and 2020 is as follows:

Statutory U.S. federal income tax rate
Nondeductible executive compensation
Impact of share-based payment awards
Tax effect of foreign items
State income taxes, net of federal benefit
U.S. and foreign tax credits
Nondeductible transaction costs
Nondeductible expenses and other
NOL adjustment due to change in GILTI
regulations
Change in valuation allowance, federal and
state
Effective tax rate

2022

2021

2020

21.0 %
(5.5)
(4.8)
(5.7)
(0.8)
3.6
—
7.0

—

(23.7)
(8.9) %

21.0 %
(6.1)
(3.3)
(30.8)
6.8
2.5
—
(4.0)

21.0 %
(0.9)
(12.4)
(70.7)
26.0
34.9
(2.8)
(2.6)

—

308.9

(133.6)
(147.5) %

(624.8)
(323.4) %

F-23

Deferred income taxes reflect the tax effects of temporary differences between the basis of assets and liabilities recognized for financial
reporting purposes and tax purposes, and net operating loss and tax credit carryforwards. Significant components of the Company's
deferred tax assets (liabilities) as of December 31, 2022 and 2021 are as follows:

Deferred tax assets (liabilities):

Net operating loss carryforwards
Inventories
Capitalized research and development costs
Accruals and reserves currently not deductible
Acquired intangible assets
Depreciation and amortization
Right-of-use assets
Lease liabilities
Stock-based compensation
Tax credit carryforwards
Net deferred tax asset
Valuation allowance
Net deferred tax liability

2022

2021

39,783
4,504
6,505
2,799
(2,641)
(6,227)
(2,775)
2,990
3,032
4,509
52,479
(52,887)

(408) $

44,191
4,642
453
3,245
(3,117)
(8,536)
(2,777)
2,957
1,891
3,855
46,804
(49,038)
(2,234)

In assessing the realizability of the Company's deferred tax asset, the Company considers all relevant positive and negative evidence in
determining whether it is more likely than not that some portion or all of the deferred income tax assets will not be realized. The
realization of the gross deferred tax assets is dependent upon several factors, including the generation of sufficient taxable income prior
to the expiration of the NOL carryforwards. In 2008, the Company established a full valuation allowance against the Company's U.S.
deferred tax asset, and management believes the full valuation allowance is still appropriate as of December 31, 2022 and 2021 since
the facts and circumstances necessitating the allowance have not changed. As a result, no U.S. federal income tax benefit was recorded
for the years ended December 31, 2022, 2021, and 2020.

The Company's Federal NOL carryforwards expire as follows:

Year of Expiration
2030 - 2033
2034 - 2037
Non-Expiring

NOLs

36,107
12,055
117,885
166,047

The Tax Reform Act of 1986 contains provisions under Internal Revenue Code (“IRC”) Section 382 that limit the annual amount of
federal and state NOL carryforwards that can be used in any given year in the event a significant change in ownership. The Company
does not believe that there is a Section 382 limitation that will impair the Company's future ability to utilize NOLs to offset the
Company's future taxable income. The Company continues to review ownership changes on an annual basis and the Company does not
believe it has had a subsequent ownership change that would impact the NOLs.

In January 2022, approximately $65,000 was repatriated from the Company's Canadian subsidiary as a one-time event. Associated with
this repatriation the Company paid $1.7 million in Canadian withholding tax which is included in the Company's foreign income tax
expense within the table further above. It is still the Company's intention to continue to permanently reinvest the historical undistributed
earnings of the Company's foreign subsidiary to the extent that the Company will not incur any additional tax expense associated with
foreign withholding or other local tax expense on the future cash transfers. As such, deferred taxes have not been recorded on the
unremitted earnings of the foreign subsidiary as of December 31, 2022.

F-24

As of December 31, 2022, the Company's gross unrecognized tax benefits totaled $373, and based upon the valuation allowance for the
Company's U.S. operations, the recognition of any tax benefit would not impact the Company's effective tax rate. The Company records
interest and penalties related to unrecognized tax benefits as a component of income tax expense. Interest and penalties were immaterial
in 2022, 2021, and 2020. As a result of the Company's net operating loss carryforward position, the Company is subject to audit by the
Internal Revenue Service since the Company's inception, as well as by several state jurisdictions for the years ended September 30, 1998
through December 31, 2022.

A reconciliation of the Company's unrecognized tax benefits is as follows:

Balance as of January 1
Additions for tax positions of prior periods
Reductions for tax positions of prior periods
Balance as of December 31

2022

2021

2020

805 $
1
(433)
373 $

1,172 $
1
(368)
805 $

1,308
1
(137)
1,172

11.

STOCKHOLDERS’ EQUITY:

Stock-Based Awards

The Company grants stock-based awards under the OraSure Technologies, Inc. Stock Award Plan, as amended (the “Stock Plan”). The
Stock Plan permits stock-based awards to employees, outside directors and consultants or other third-party advisors. Awards which may
be granted under the Stock Plan include qualified incentive stock options, nonqualified stock options, stock appreciation rights, restricted
awards, performance awards and other stock-based awards.

As of December 31, 2022, 3,921 shares were available for future grants under the Stock Plan.

Under the terms of the Stock Plan, nonqualified stock options may be granted to eligible employees, including the Company's officers
at a price not less than 75 percent of the fair market value of a share of common stock on the date of grant. The option term and vesting
schedule of such awards may be either unlimited or have a specified period in which to vest and be exercised. To date, options generally
have been granted with ten-year exercise periods and an exercise price not less than the fair market value on the date of grant. Options
generally vest over four years, with one quarter of the options vesting one year after grant and the remainder vesting on a monthly basis
over the next three years.

The fair value of each stock option was estimated on the date of the grant using the Black-Scholes option-pricing model using the
following weighted-average assumptions:

Black-Scholes Option Valuation Assumptions
Risk-free interest rate(1)
Expected dividend yield
Expected stock price volatility(2)
Expected life of stock options (in years)(2)

Years Ended December 31,

2022

2021

2020

1.65 %
—
50 %
5

0.47 %
—
50 %
5

1.33 %
—
42 %
5

(1)

(2)

Based on the constant maturity interest rate of U.S. Treasury securities whose term is consistent with the expected life of the
Company's stock options.
Based upon historical experience.

The weighted-average grant date fair value of stock options granted during the years ended December 31, 2022, 2021, and 2020 was
$4.15, $6.14 and $2.79, respectively.

Compensation expense recognized in the financial statements related to stock options was $1,515, 1,063, and $892 for the years ended
December 31, 2022, 2021, and 2020, respectively.

The aggregate intrinsic value of options exercised during the years ended December 31, 2022, 2021, and 2020 (the amount by which
the market price of the stock on the date of exercise exceeded the exercise price) was $4, $130, and $3,117, respectively.

F-25

The following table summarizes the stock option activity under the Stock Plan:

Weighted-
Average
Exercise Price
Per Share

Options

Weighted-
Average
Remaining
Contractual
Term
(in years)

Aggregate
Intrinsic
Value

Outstanding on January 1, 2022

Granted
Exercised
Expired
Forfeited

Outstanding on December 31, 2022
Vested or expected to vest as of December 31,
2022
Exercisable on December 31, 2022

1,410 $
589
(2)
(28)
(211)
1,758 $

1,633 $
1,045 $

10.73
8.86
7.17
10.01
9.63
10.25

10.29
10.67

6.54 $

7.03 $
5.11 $

—

—
—

As of December 31, 2022, there was $2,583 of unrecognized compensation expense related to unvested option awards that is expected
to be recognized over a weighted-average period of 2.6 years.

Net cash proceeds from the exercise of stock options were $15, $246 and $3,222 for the years ended December 31, 2022, 2021, and
2020, respectively. As a result of the Company's net operating loss carryforward position, no actual income tax benefit was realized
from stock option exercises for these periods.

The following table summarizes information about stock options outstanding as of December 31, 2022:

Options outstanding

Options exercisable

Weighted-
Average
Remaining
Contractual
Term
(in years)

Weighted-
Average
Exercise
Price Per
Share

Number
Exercisable

7.2 $
4.8
6.5
6.5 $

7.83
10.67
16.79
10.25

435 $
357
253
1,045 $

6.83
10.64
17.30
10.67

Number
Outstanding
1,036
362
360
1,758

Range of exercise prices
$5.37-$8.86
$8.87-$13.31
$14.95-$22.43

The Stock Plan also permits the Company to grant restricted shares and restricted units of the Company's common stock to eligible
employees, including officers, and the Company's outside directors. Generally, these shares or units are nontransferable until vested and
are subject to vesting requirements and/or forfeiture, as determined by the Company's Compensation Committee or Board of Directors.
The market value of these shares and units at the date of grant is recognized on a straight-line basis over the period during which the
vesting restrictions lapse. Compensation cost of $9,169, $4,094 and $4,094 related to restricted shares was recognized during the years
ended December 31, 2022, 2021, and 2020, respectively.

The following table summarizes restricted stock award and restricted stock units activity under the Stock Plan:

Issued and unvested, January 1, 2022

Granted
Vested
Forfeited

Issued and unvested, December 31, 2022

Issued and expected to vest, December 31, 2022

F-26

Weighted-
Average Grant
Date Fair
Value

11.53
6.45
9.50
9.47
6.51
6.53

Units

701
2,995
(750)
(373)
2,573
2,538

$
$

As of December 31, 2022, there was $11,185 of unrecognized compensation expense related to unvested restricted stock awards and
unvested restricted stock units that is expected to be recognized over a weighted average period of 1.8 years.

In connection with the vesting of restricted shares during the years ended December 31, 2022, 2021, and 2020, the Company purchased
and immediately retired 241, 107 and 127 shares with aggregate values of $1,621, $1,417 and $1,219, respectively, in satisfaction of
minimum tax withholding and exercise obligations.

The Company grants performance-based restricted stock units (“PSUs”) to certain executives. Vesting of these PSUs is dependent upon
achievement of certain performance-based metrics during a one-year or three-year period, from the date of grant. Assuming achievement
of each performance-based metric, the executive must also generally remain in the Company's service for three years from the grant
date. Prior to 2021, performance during the one-year period was based on a one-year income before tax target. Performance during the
three-year period was based on achievement of a three-year compound annual growth rate for consolidated revenues. In 2021 and 2022,
performance shares were granted based on the achievement of three-year cumulative revenue metrics with a market-based condition, or
a total shareholder return modifier. PSUs are converted into shares of the Company's common stock once vested and the number of
shares actually earned at the end of the performance period will vary, based on actual performance, from 0% to 200% of the target
number of performance share units granted. Upon grant of the PSUs, the Company recognizes compensation expense related to these
awards based on assumptions as to what percentage of each target will be achieved. The Company evaluates these target assumptions
on a quarterly basis and adjusts compensation expense related to these awards, as appropriate.

Compensation cost of $938, $2,650 and $2,153 related to the PSUs was recognized during the years ended December 31, 2022, 2021,
and 2020, respectively.

The following table summarizes PSU activity under the Stock Plan:

Issued and unvested, January 1, 2022

Granted (1)
Performance adjustment (2)
Vested
Forfeited

Issued and unvested, December 31, 2022

Issued and expected to vest, December 31, 2022

Weighted-
Average Grant
Date Fair
Value

Units

622 $
532
36
(241)
(234)
715 $
698 $

9.88
8.86
N/A
11.09
10.50
6.86
6.82

(1)

(2)

Grant activity for all PSUs disclosed at target.
Reflects the performance adjustment based on actual performance measured at the end of the performance period.

As of December 31, 2022, there was $316 of unrecognized compensation expense related to unvested performance stock units that is
expected to be recognized over a weighted average period of 1.6 years.

In connection with the vesting of performance stock units during the year ended December 31, 2022, 2021 and 2020, we purchased and
immediately retired 88, 46, and 121 shares with aggregate values of $633, $696 and $869, respectively.

Public Offering

On June 1, 2020, the Company entered into an underwriting agreement with J.P. Morgan Securities LLC, Citigroup Global Markets Inc.
and Evercore Group LLC, as representatives of several underwriters, relating to the issuance and sale of 8,000 shares of the Company's
common stock. The price to the public in the offering was $11.00 per share. Under the terms of the underwriting agreement, the Company
also granted the underwriters an option, exercisable for 30 days, to purchase up to an additional 1,200 shares of common stock. On June
3, 2020, the Company announced the full exercise by the underwriters of their option to purchase these additional shares.

The offering was made pursuant to an effective registration statement on Form S-3 (File No. 333-228877) the Company had previously
filed with the SEC, and a prospectus supplement thereunder. The net proceeds from the offering were approximately $95,000 after
deducting underwriting discounts and offering expenses paid by the Company.

F-27

Share Repurchase Program

On August 5, 2008, the Company's Board of Directors approved a share repurchase program pursuant to which the Company is permitted
to acquire up to $25,000 of the Company's outstanding common shares. No shares were purchased and retired in 2022, 2021, and 2020.

12.

TRANSITION COSTS

On December 31, 2021, the Company's Board of Directors approved the termination of Stephen S. Tang, the Company’s President and
Chief Executive Officer, without cause under his existing employment agreement with the Company, with such termination effective as
of March 31, 2022. On January 2, 2022, Dr. Tang and the Company entered into a Transition Agreement providing for the terms of the
cessation of Dr. Tang’s employment with the Company, including the cessation of his service as President and Chief Executive Officer
of the Company and as a member of the Board. Under the Transition Agreement, Dr. Tang’s service to the Company in all capacities
ended on March 31, 2022.

Pursuant to the Transition Agreement, Dr. Tang received severance of $1,569, which was accrued in the consolidated financial
statements at December 31, 2021 and paid in April 2022. Additionally, in accordance with his Transition Agreement, certain of his
unvested time-vesting restricted stock awards and unvested PSUs that were outstanding at March 31, 2022 vested on April 8, 2022. His
remaining unvested time-vesting restricted stock awards and PSUs were forfeited on March 31, 2022. These payments, rights and
benefits are substantially similar to the severance benefits contemplated by his previous employment agreement in respect to a
termination without cause thereunder. In aggregate, the Company recognized $1,508 of expense in relation to Dr. Tang's stock
compensation for the year ended December 31, 2022.

13. BUSINESS SEGMENT INFORMATION:

The Company's business consists of two segments, which are described in Note 1: the Company's “Diagnostics” segment and the
Company's “Molecular Solutions” segment.

The Company organized its operating segments according to the nature of the products included in those segments. The accounting
policies of the segments are the same as those described in the summary of significant accounting policies (see Note 2). The Company
evaluates performance of its operating segments based on revenue and operating income. The Company does not allocate interest
income, interest expense, other income, other expenses or income taxes to its operating segments. Reportable segments have no inter-
segment revenues and inter-segment expenses have been eliminated.

The following table summarizes operating segment information for the years ended December 31, 2022, 2021, and 2020, and asset
information as of December 31, 2022 and 2021:

Net revenues:
Diagnostics
Molecular Solutions

Total

Operating income (loss):

Diagnostics
Molecular Solutions

Total

Depreciation and amortization:

Diagnostics
Molecular Solutions

Total

Capital expenditures:

Diagnostics(1)
Molecular Solutions

Total

Years ended December 31,
2021

2020

2022

303,673 $
83,806
387,479 $

90,040 $
143,634
233,674 $

65,240
106,481
171,721

(598) $

(22,359)
(22,957) $

(57,177) $
47,013
(10,164) $

(43,156)
37,979
(5,177)

8,099 $
7,209
15,308 $

4,325 $
7,333
11,658 $

3,644 $
3,130
6,774 $

12,265 $
9,628
21,893 $

3,345
6,042
9,387

17,860
8,814
26,674

F-28

(1) Excludes $57,135 and $26,224 for purchases of property and equipment under government contracts for the years ended

December 31, 2022 and 2021 respectively. No purchases of property and equipment under government contracts were made in
2020.

Total assets:

Diagnostics
Molecular Solutions

Total

The following table represents total long-lived assets by geographic area:

United States
Canada
Other regions

14. COMMITMENTS AND CONTINGENCIES:

Purchase Commitments

December 31,

2022

2021

279,994
164,714
444,708

209,674
251,316
460,990

December 31,

2022

2021

60,751
8,526
1,828
71,105

72,376
11,488
1,120
84,984

As of December 31, 2022, the Company had manufacturing agreements with certain third party vendors, in which minimum purchase
commitments are required.
If the minimum commitments are not achieved, the Company will be required to make annual penalty
payments over the next three years. Based on current forecasts, these penalties aggregate to approximately $1,143 and are accrued for
in the consolidated balance sheet. These estimated penalties can fluctuate based on changes in forecasted demand. The table below
represents an estimate of future purchases under those agreements.

2023
2024
2025
2026
2027

Litigation

21,710
9,695
6,928
—
—
38,333

From time to time, the Company is involved in certain legal actions arising in the ordinary course of business. In management’s opinion,
based upon the advice of counsel, the outcomes of such actions are not expected, individually or in the aggregate, to have a material
adverse effect on the Company's future financial position or results of operations.

Spectrum Patent Litigation

In March 2021, DNAG filed a complaint against Spectrum Solutions, LLC ("Spectrum") in the United States District Court for the
Southern District of California alleging that certain saliva collection devices manufactured and sold by Spectrum infringe a patent held
by DNAG. Spectrum has filed an answer to the initial complaint, asserting that its device does not infringe DNAG's patent and that
DNAG's patent is invalid. In August 2021, DNAG amended its complaint to add a second patent to this litigation. Spectrum responded
to DNAG's amended complaint and asserted counterclaims for inequitable conduct and antitrust violations with respect to one of the
patents in the litigation and subsequently filed a request for review of the second patent at the Patent and Trademark Office. DNAG
filed a motion to dismiss Spectrum’s counterclaims in October 2021, which was denied by the Court on March 30, 2022. Expert
discovery is ongoing. On November 29, 2022, the district court issued a claim construction order. On January 30, 2023, Spectrum filed
a motion for summary judgment of noninfringement. DNAG oppossed the motion. Briefing is complete and the motion remains pendng.
The final pretrial conference is set for September 7, 2023. The Patent and Trademark Office instituted review of the second patent on
February 10, 2023, scheduling a hearing for November 14, 2023.

F-29

15. RETIREMENT PLANS:

Substantially all of the Company's U.S. employees are eligible to participate in the OraSure Technologies, Inc. 401(k) Plan (the “401(k)
Plan”). The 401(k) Plan permits voluntary employee contributions to be excluded from an employee’s current taxable income under
provisions of Internal Revenue Code Section 401(k) and the regulations thereunder. The 401(k) Plan also provides for the Company to
match employee contributions up to $4 per year. The Company contributed $1,763, $1,295 and $994 to the 401(k) Plan, net of forfeitures,
in 2022, 2021, and 2020, respectively.

In addition to the Company's 401(k) plan, the Company offers a nonqualified deferred compensation plan to permit eligible directors
and highly compensated employees of the Company to defer receipt and taxation of their compensation each year. The Company also
may make discretionary contributions to the accounts of the participating employees in any amount either in cash or stock. Participants
in the plan may not purchase OraSure stock as an investment vehicle. As of December 31, 2022 and 2021, the value of the assets
associated with this plan was $747 and $1,763, respectively, and is included in current assets and other assets in the Company's
consolidated balance sheets. The Company's obligation related to the deferred compensation plan is included in accrued expenses and
other liabilities in the Company's consolidated balance sheets. As of December 31, 2022 and 2021, the Company's total obligation under
this plan was $747 and $1,763, respectively.

Substantially all regular full-time Canadian employees are eligible to participate in the DNA Genotek Registered Retirement Savings
Plan (the “RRSP”). The RRSP permits voluntary employee contributions to be excluded from an employee’s current taxable income
and receive tax preferred treatment with Canada Revenue Agency. The RRSP also provides for DNAG to match employee contributions
up to $4 CAD per year. The Company contributed $453, $448 and $366 to the RRSP in 2022, 2021, and 2020, respectively.

16.

SUBSEQUENT EVENTS:

On February 14, 2023, the Company announced a 11% reduction in its non-production workforce. This will be accounted for pursuant
to ASC 420, Exit or Disposal Cost Obligations, and the expense will primarily be recorded in the first quarter of 2023.

F-30

[THIS PAGE INTENTIONALLY LEFT BLANK]

BOARD OF DIRECTORS AND EXECUTIVE OFFICERS

BOARD OF DIRECTORS

EXECUTIVE OFFICERS

Carrie Eglinton Manner

President and Chief Executive Officer, OraSure Technologies, Inc.

Carrie Eglinton Manner
President and Chief Executive Officer

Mara G. Aspinall (1,2)

Chairman of Board of Directors
Chairman of the Audit Committee
Managing Member, Health Catalysts Group
Managing Director, Blue Stone Venture Partners

Kenneth J. McGrath
Chief Financial Officer

Kathleen G. Weber
Chief Product Officer

James A. Datin (1,2)

Chairman of the Compensation Committee
President and Chief Executive Officer, BioAgilytix Labs, LLC

Nancy J. Gagliano, M.D. (3)

Chairman of the Nominating & Corporate Governance Committee
Chief Executive Officer, Granite Healthcare Advisors

Lelio Marmora (2,3)
President and Chief Executive Officer, The Management Lab

David J. Shulkin, M.D. (1,3)

President, Shulkin Solutions, Inc.

Anne C. Whitaker (2)
Managing Partner, Anne Whitaker Group, LLC
________________________________________
Committees of the Board
1. Compensation
2. Audit
3. Nominating and Corporate Governance