OraSure Technologies Receives World Health Organization Prequalification of OraQuick(R) HIV Self-Test
WHO Prequalification will enable procurement of OraQuick(R) 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(R) 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(R) 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(R) 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. |
