OraSure Wins Contract to Supply “Together Take Me Home,” HIV Self-Testing Initiative Sponsored by the Centers for Disease Control and Prevention

BETHLEHEM, Pa., Sept. 20, 2022 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (NASDAQ: OSUR), a global leader in point-of-care and home diagnostic testing and sample collection technologies, announced today that the Company has been selected to provide its OraQuick^® In-Home HIV tests in support of the Centers for Disease Control and Preventions (CDC) “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.

Almost 1.2 million people aged 13 and older have HIV in the United States, including an estimated 158,500 who don’t know they have it. Identifying these individuals and linking them to care is a crucial element of the Ending the HIV Epidemic initiative and empowers these individuals and their communities to take control of their healthcare. The “Together Take Me Home” program helps address testing barriers, including stigma, privacy concerns, cost, and lack of access to traditional HIV clinics by offering HIV self-tests through mail delivery. This program follows a successful collaborative pilot program by the same name, for which OraSure also supplied tests.

As part of the program, OraSure will provide up to one million OraQuick^® In-Home HIV tests over a five- year period. Emory University and partner organizations will manage the program and provide logistical and distribution services for the tests. 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.

“We are proud to work with the Centers for Disease Control and Emory to help support broader HIV testing and awareness in underserved communities across the United States,” said Lisa Nibauer, President of Diagnostics for OraSure Technologies. “Programs such as the Together Take Me Home initiative show that the government can take an active role in making a difference against the major public health crises that we face as a country and to support marginalized populations. We firmly believe that these programs reduce the spread of diseases that disproportionately affect marginalized communities and lower overall cost to the healthcare system by identifying patients early, connecting them to care, and allowing for successful interventions that lead to empowering lives informed by ones HIV status.”

About OraSure Technologies

OraSure Technologies empowers the global community to improve health and wellness by providing access to accurate, essential information. OraSure, together with its wholly-owned subsidiaries, DNA Genotek, Diversigen, and Novosanis, provides its customers with end-to-end solutions that encompass tools, services and diagnostics. The OraSure family of companies is a leader in the development, manufacture, and distribution of rapid diagnostic tests, sample collection and stabilization devices, and molecular services solutions designed to discover and detect critical medical conditions. OraSure’s portfolio of products is sold globally to clinical laboratories, hospitals, physician’s offices, clinics, public health and community-based organizations, research institutions, government agencies, pharma, commercial entities and direct to consumers. For more information on OraSure Technologies, please visit .

About OraSure Technologies’ HIV Tests

The OraQuick ADVANCE^® Rapid HIV-1/2 Antibody Test is the first FDA approved, CLIA-waived, rapid point-of care test that can detect antibodies to both HIV-1 and HIV-2 with greater than 99 percent accuracy in as little as 20 minutes, using an oral fluid, finger-stick or venipuncture whole blood, or plasma sample. The OraQuick^® In-Home HIV Test is the first and only oral fluid rapid over-the-counter (OTC) HIV test approved in the U.S. The OraQuick^® In-Home HIV Test can detect antibodies to both HIV-1 and HIV-2 with an oral swab, providing a confidential in-home testing option with results in as little as 20 minutes. It is the first rapid diagnostic test for any infectious disease that has been approved by the FDA for sale to the consumer market. The OraQuick^® HIV Self-Test (HIVST) is a rapid, point-of-care test that allows an individual to detect antibodies to both HIV-1 and HIV-2 with a simple oral swab and provides a result in as little as 20 minutes in the privacy of an individual’s home, at outreach testing settings, in the pharmacy or at community-based screening events. Based on the same OraQuick^® platform that is used for the FDA-approved OraQuick^® In-Home HIV Test and the WHO Prequalified OraQuick^® Rapid HIV-1/2 Antibody Test used by health care professionals worldwide, the platform has been used to test millions in international markets.

Important Information

This press release contains certain forward-looking statements, including with respect to the Company’s products, product development activities, regulatory submissions and authorizations and other matters. 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: risk that the Company's exploration of strategic alternatives may not result in any definitive transaction or enhance stockholder value and may create a distraction or uncertainty that may adversely affect operating results, business or investor perceptions; the diversion of management’s attention from the Company's ongoing business and regular business responsibilities due to the Company's exploration of strategic alternatives; ability to resolve the Company's ongoing manufacturing challenges and satisfy customer demand; ability to market and sell products, whether through our internal, direct sales force or third parties; impact of significant customer concentration in the genomics business; failure of distributors or other customers to meet purchase forecasts, historic purchase levels or minimum purchase requirements for our products; ability to manufacture products in accordance with applicable specifications, performance standards and quality requirements; 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; ability to effectively resolve warning letters, audit observations and other findings or comments from the U.S. Food and Drug Administration (“FDA”) or other regulators; the impact of the novel coronavirus (“COVID-19”) pandemic on the Company's business and ability to successfully develop new products, validate the expanded use of existing collector products, receive necessary regulatory approvals and authorizations and commercialize such products for COVID-19 testing; 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; ability to meet increased demand for the Company’s products; impact of replacing distributors; inventory levels at distributors and other customers; ability of the Company to achieve its financial and strategic objectives and continue to increase its revenues, including the ability to expand international sales; impact of competitors, competing products and technology changes; reduction or deferral of public funding available to customers; competition from new or better technology or lower cost products; 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 (“CDC”) or other agencies; ability to fund research and development and other products and operations; 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; impact of contracting with the U.S. government; impact of negative economic conditions; ability to maintain sustained profitability; ability to utilize net operating loss carry forwards or other deferred tax assets; volatility of the Company’s 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; 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; ability to attract and retain qualified personnel; 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. These and other factors that could affect our results are discussed more fully in our SEC filings, including our registration statements, Annual Report on Form 10-K for the year ended December 31, 2021, Quarterly Reports on Form 10-Q, and other filings with the SEC. 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 are made as of the date of this press release and OraSure Technologies undertakes no duty to update these statements.