OraSure Technologies Inc. (NASDAQ:OSUR) said the U.S. Food and Drug Administration (FDA) set May 15 date for Blood Products Advisory Committee (BPAC) review of OraSure over-the-counter rapid HIV-1/2 test.
The advisory committee would consider the company's application for the approval of its OraQuick Rapid HIV-1/2 test, which is an over-the-counter version of the OraQuick ADVANCE product currently sold into the professional market.
Chief Executive Douglas Michels believes that the availability of an easy-to-use, accurate in-home HIV test will enable more people to learn their presumptive HIV status so that they can receive necessary care and support.
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The company said it would be presenting the findings from the final phase of clinical testing, which involved the use of the OraQuick In-Home HIV Test, an OTC investigational use version of the OraQuick ADVANCE Rapid HIV-1/2 test, by individuals in an unobserved setting.
About 5,800 subjects were enrolled and tested in this phase across 20 sites nationwide, resulting in the identification of more than 100 previously undiagnosed individuals with HIV.
OraSure currently manufactures and sells the OraQuick ADVANCE Rapid HIV-1/2 Test which is the first and only FDA-approved and CLIA-waived rapid point-of-care test that can detect antibodies to both HIV-1 and HIV-2 in oral fluid in 20 minutes.
As the market leading rapid HIV test with over 20 million tests sold, OraQuick ADVANCE is used extensively throughout the United States in public health settings, hospitals, community-based organizations, and physician offices where HIV testing is conducted.
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OSUR is trading down 2.27% at $11.21 on Wednesday. The stock has been trading between $6.29 and $11.78 for the past 52 weeks.