WHO Prequalification will enable procurement of OraQuick® HIV Self-Test with monies from global public health funding sources
BETHLEHEM, Pa., July 21, 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 Prequalified by the World Health Organization (WHO).
The OraQuick HIV Self-Test 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, 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. Since the product was first launched, over 40 million tests have been used by health care professionals and individuals worldwide.
WHO Prequalification aims to 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. The Prequalification process entails a rigorous assessment of a product’s technical performance. Data supporting the OraQuick HIVST Prequalification demonstrate that the test was 100% sensitive and greater than 99% specific when compared to a fourth generation laboratory test.
WHO Prequalification is used by United Nations and other procurement agencies such as PEPFAR, UNITAID and/or the Global Fund to make purchasing decisions regarding diagnostics, medicines and/or vaccines. OraSure Technologies also recently entered into an agreement with the Bill & Melinda Gates Foundation to reduce the price of the OraQuick HIV Self-Test in 50 developing countries to accelerate the adoption and deployment of the test.
“We are pleased to offer the first rapid HIV Self-Test to have received WHO Prequalification,” said Douglas A. Michels, President and CEO of OraSure Technologies. “WHO Prequalification enables government organizations implementing HIV Self-Test pilots and programs to access funding for the OraQuick HIV Self-Test. We believe this easy-to-use and reliable Self-Test product is a critical tool for meeting the UNAIDS’s 90/90/90 diagnosis and treatment targets set for 2020 and will be vital to improving the health and wellness of those living with HIV on a global scale. The Prequalification also reaffirms that our HIV Self-Test meets the stringent technical and quality standards that we place on all of our products.”
Based on its performance and ease of use, the OraQuick HIV Self-Test was selected and is being used in the UNITAID/PSI HIV Self-Testing Africa (STAR) Project. Phase I of the STAR project aims to improve access to HIV testing through simple HIV self-tests in three high-burden African countries – Malawi, Zambia and Zimbabwe, and represents the world’s largest evaluation of HIV self-testing to date.
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 www.orasure.com.
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
Corporate Marketing Manager