OraSure Technologies Inc., the market leader in oral fluid diagnostics, will present at a meeting of the Blood Products Advisory Committee (BPAC) of the US FDA a proposal for an over-the-counter home-use rapid HIV test kit.
According to a company release, OraSure Technologies is the manufacturer of the OraQuick advance rapid HIV-1/2 antibody test, the first and only FDA approved, CLIA waived, rapid point-of-care test that provides results for both HIV-1 and HIV-2 with greater than 99 per cent accuracy in as little as 20 minutes, using an oral fluid, finger-stick or venipuncture whole blood or plasma sample
The BPAC advises the commissioner of food and drugs in discharging his responsibilities as they relate to helping to ensure safe and effective biological products and related medical devices, and, as required, any other product for which the FDA has regulatory responsibility. The committee reviews and evaluates available data concerning the safety, effectiveness, and appropriate use of blood products derived from blood and serum or biotechnology which are intended for use in the diagnosis, prevention, or treatment of human diseases.
It also reviews other product for which the FDA has regulatory responsibility, and advises the commissioner of food and drugs of its findings regarding the safety, effectiveness, and labelling of the products, on clinical and laboratory studies involving such products, on the affirmation or revocation of biological product licenses, and on the quality and relevance of FDA's research programme which provides the scientific support for regulating these agents.
OraSure Technologies develops, manufactures and markets oral fluid specimen collection devices using proprietary oral fluid technologies, diagnostic products including immunoassays and other in vitro diagnostic tests, and other medical devices.