OraSure Technologies Continues its Dedication to Ending the HIV Epidemic

BETHLEHEM, Pa., Dec. 01, 2022 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (NASDAQ: OSUR), a global leader in the fight against HIV, will ring the closing bell for the Nasdaq Stock Market this afternoon in honor of World AIDS Day. World AIDS Day is commemorated annually on December 1 to raise awareness of the AIDS epidemic and to mourn the loss of those who have died of the disease. The U.S. Government's theme for this year’s World AIDS Day is “Putting Ourselves to the Test: Achieving Equity to End HIV,” to emphasize the importance of uplifting marginalized and vulnerable groups who bear the brunt of the burden of HIV in the country. 

“OraSure has played a critical role in the fight against HIV globally since 2002. For more than two decades, we have championed the importance of access to personal information about health through easy-to-use diagnostics, particularly for vulnerable communities around the world most burdened by HIV,” said OraSure President and CEO Carrie Eglinton Manner. “Today we vow to continue that fight, both globally through partnership with non-governmental organizations that provide tests to low- and middle-income countries to help combat the HIV crisis, and domestically through innovative programs like the Centers for Disease Control and Preventions (CDC) ‘Take Me Home,’ HIV self-test program.”  

Under the CDC program, OraSure may supply up to one million OraQuick® In-Home HIV tests to engage individuals who are disproportionately affected by HIV and less likely to have access to key diagnostic, prevention, and treatment services across the United States. 

Almost 1.2 million people aged 13 and older have HIV in the United States, including an estimate of nearly 160,000, who currently do not know that they are infected. Identifying these individuals and linking them to care is a crucial priority for eradicating HIV. With pre-exposure prophylaxis (PrEP), a medication used by HIV-negative individuals to prevent HIV seroconversion, people can take control of their health and prevent infection before it starts. For people living with HIV, effective treatment allows them to enjoy long and healthy lives and, with an undetectable viral load, means that they cannot transmit HIV through sex. This is commonly known as U=U, or “undetectable equals untransmittable.” 

OraSure was the first company to receive FDA approval for a professional-use rapid HIV-1 test in 2002 with its OraQuick® Rapid HIV-1 Antibody Test. In 2012, the Company received FDA approval for the first, and still only, over-the-counter oral fluid HIV test, the OraQuick® In-Home HIV Test. In 2017, the Company received World Health Organization (WHO) prequalification for the OraQuick® HIV Self-Test, which is sold for use by individuals internationally, including significant use in sub-Saharan Africa which has the highest rates of HIV globally. More than 90 million OraQuick® HIV tests have been used worldwide in more than 130 countries, helping link those who test positive to appropriate confirmation testing and care. The Company is also developing new diagnostic tests to support clinicians in improving adherence to PrEP, ensuring that the medication is used consistently so that high-risk individuals without HIV remain free of infection. 

In addition to the Nasdaq closing bell ceremony, OraSure employees will also meet with key opinion leaders and those who help represent and serve marginalized communities most burdened by HIV and will support awareness, testing and treatment initiatives around the globe.  

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.