OraSure Technologies Remains Committed to the Global Fight Against HIV 40 Years After the Discovery of the HIV Virus

Company to Ring Nasdaq Closing Bell and Host Panel Discussions on HIV in New York City

BETHLEHEM, Pa., Nov. 30, 2021 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (NASDAQ: OSUR), a global leader in the fight against HIV, today announced its plans for World AIDS Day. Commemorated annually on December 1, the U.S. Government's theme for this year’s World AIDS Day is “Ending the HIV Epidemic: Equitable Access, Everyone's Voice.” This year also marks 40 years since the first five cases of what later became known as AIDS were officially reported.

“When we look back at the past 40 years, we see a disease that was unfortunately often politicized and placed in a cultural context, as opposed to being recognized as a critical public health risk, frequently to the great detriment of the many affected marginalized communities,” said OraSure President and CEO, Stephen S. Tang, Ph.D. “However, through multi-stakeholder collaboration between public and private organizations, great progress has been made during the past 40 years with regard to prevention, diagnosis, linkage to care and treatment. OraSure is proud to be an innovator in the field of HIV, and a global leader in driving simple point-of-care testing and awareness.”

OraSure was the first company to receive FDA approval for a professional-use rapid HIV-1/2 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 in many countries internationally, including sub-Saharan Africa. More than 70 million OraQuick® HIV tests have been used worldwide in more than 130 countries, helping link those who test positive to the necessary follow-up resources and care. The Company also develops diagnostic tests that measure and improve adherence to PrEP, a medication used by HIV-negative individuals to prevent HIV seroconversion.

In honor of World AIDS Day, OraSure will ring the closing bell for the Nasdaq Stock Market on November 30th. The bell ringing ceremony will be preceded by an expert panel discussion entitled "The 40-year Story of HIV: Then and Now,” at Nasdaq Marketsite on Times Square in New York City and will cover the history of the HIV epidemic, including considerations for treatment in the time of the COVID-19 pandemic.

The panel discussion will open with remarks from Harold Phillips, who leads the Office of National AIDS Policy (ONAP) as part of the U.S. President’s Domestic Policy Council. Following his remarks, a moderated discussion will be held with Stephen Lee, M.D., Executive Director of the National Alliance of State and Territorial AIDS Directors (NASTAD); Vincent Guilamo-Ramos, Ph.D., member of the U.S. Presidential Advisory Council on HIV/AIDS and Dean of the School of Nursing and Vice Chancellor of Nursing Affairs at Duke University; Ingrid Floyd, Executive Director at Iris House and WORLD; and Marc Meachem, Head of External Affairs at ViiV Healthcare. The panel will be moderated by Debra Fraser-Howze, founder of the National Black Leadership Commission on AIDS and founder of Choose Healthy Life.

In addition to these events in New York, OraSure employees and customers will take part in HIV testing efforts around the globe on World AIDS Day. As part of its corporate philanthropy, the Company also provides sponsorship funds year-round to more than a dozen non-profit organizations that focus on ending the HIV epidemic and has provided thousands of free tests used both domestically and internationally, particularly in sub-Saharan Africa, to help people know their HIV status.

“The world has been fighting the AIDS epidemic for 40 years, and we have made progress, but there is still work to do,” Tang said. “OraSure has a long tradition of tackling our greatest public health challenges and we believe it’s time to end the story of HIV and as a Company we stand ready to help make this vision a reality.”

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.

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 www.orasure.com.

Important Information

This document contains certain forward-looking statements, including with respect to expected revenues and earnings/loss per share. 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: ability of the Company to manufacture sufficient quantities of the InteliSwab™ COVID-19 rapid test; ability to successfully manage and integrate acquisitions of other companies in a manner that complements or leverages our existing business, or otherwise expands or enhances our portfolio of products and our end-to-end service offerings, and the diversion of management’s attention from our ongoing business and regular business responsibilities to effect such integration; the expected economic benefits of acquisitions (and increased returns for our stockholders), including that the anticipated synergies, revenue enhancement strategies and other benefits from the acquisitions may not be fully realized or may take longer to realize than expected and our actual integration costs may exceed our estimates; impact of increased or different risks arising from the acquisition of companies located in foreign countries; 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 our business and our ability to successfully develop new products, validate the expanded use of existing collection products 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; ability to identify, complete, integrate and realize the full benefits of future acquisitions; 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 Securities and Exchange Commission (“SEC”) filings, including our registration statements, Annual Report on Form 10-K for the year ended December 31, 2020, 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 we undertake no duty to update these statements.