Print Page  Close Window

Press Release

OraQuick® HIV Self-Test Selected for Next Phase of STAR Project for HIV Self-Testing in Africa (revised July 27, 2017)
~Phase II of STAR Project Expected to Deploy 4 Million Additional HIV Self-Tests~

BETHLEHEM, Pa., July 24, 2017 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (NASDAQ:OSUR), a leader in point of care diagnostic tests and specimen collection devices, today announced that its OraQuick® HIV Self-Test (HIVST) has been selected by UNITAID and Population Services International (PSI) for use in Phase II of the HIV Self-Testing Africa (STAR) Project.

The STAR Project Phase II, beginning in Q4 of 2017, will deploy HIV Self-Testing in Malawi, Zambia, Zimbabwe, South Africa and additional African countries to demonstrate the population-level health impact of HIVST over a two-year period. OraSure believes the vast majority of the 4 million tests used in Phase II are expected to be the OraQuick® HIV Self-Test.

The OraQuick® HIV Self-Test has been used in Phase I of the STAR Project, which represented the largest evaluation of HIV self-testing to date. The study distributed 750,000 OraQuick® HIV Self-Tests throughout Malawi, Zambia and Zimbabwe between 2015 and 2017. Phase I successfully demonstrated how self-testing with OraQuick® HIVST can increase the number of people who are tested and know their HIV status. The project also provided best practices for implementation, uptake and self-test delivery models to inform Phase II scale-up.

"It is estimated that 30% of adults living with HIV globally do not know their status," said Dr. Karin Hatzold, Project Director of the UNITAID/PSI STAR Project. "Through our joint project with UNITAID, we can promote self-testing to better reach people with limited access to current HIV testing services due to privacy issues or lack of convenience. It can also encourage re-testing among those at high risk."

"The findings from Phase I of the study demonstrate the significant impact that self-testing provides in diagnosing and treating individuals infected with HIV in even the most remote geographies. We believe that easy-to-use and reliable self-testing options are critical to meet the UNAIDS's 90/90/90 treatment targets set for 2020 and are vital to improving the health and wellness of those living with HIV on a global scale" said Douglas A. Michels, President and CEO of OraSure Technologies.

For more information on the STAR Project please reference the UNITAID press release

About the OraQuick® HIV Self-Test

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. The product is 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.

About OraSure Technologies

OraSure Technologies is a leader in the development, manufacture and distribution of point of care diagnostic and collection devices and other technologies designed to detect or diagnose critical medical conditions. Its first-to-market, innovative products include rapid tests for the detection of antibodies to HIV and HCV on the OraQuick® platform, oral fluid sample collection, stabilization and preparation products for molecular diagnostic applications, and oral fluid laboratory tests for detecting various drugs of abuse. OraSure's portfolio of products is sold globally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, research and academic institutions, distributors, government agencies, physicians' offices, commercial and industrial entities and consumers. The Company's products enable healthcare providers to deliver critical information to patients, empowering them to make decisions to improve and protect their health.

For more information on OraSure Technologies, please visit

Important Information

This press release 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 to market and sell products, whether through our internal, direct sales force or third parties; 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 FDA or other regulators; 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; impact of increased reliance on U.S. government contracts; failure of distributors or other customers to meet purchase forecasts, historic purchase levels or minimum purchase requirements for our 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; impact of negative economic conditions, high unemployment levels and poor credit conditions; 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 testing or other products; 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; history of losses and ability to achieve 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 meet financial covenants in credit agreements; 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 are discussed more fully in the Company's  Securities and Exchange Commission ("SEC") filings, including our registration statements, Annual Report on Form 10-K for the year ended December 31, 2016, 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. The forward-looking statements are made as of the date of this press release and OraSure Technologies undertakes no duty to update these statements.

Ronald H. Spair
Chief Financial Officer

Shauna White
Corporate Marketing Manager

Primary Logo

OraSure Technologies