FDA committee recommends approval of OraSure's in-home HIV test
Wednesday, May 16 2012 | Comments
The Food and Drug Administration
's Blood Products Advisory Committee
(BPAC) unanimously recommended approval of OraSure Technologies Inc.
's OraQuick in-home HIV test.
Specifically, the committee voted 17-0 that the projected benefits of the test outweigh the potential risk of false positive and false negative test results. The committee also voted 17-0 that the available data provide reasonable assurance that the test is safe and effective for its intended use.
The OraQuick in-home HIV test is an over-the-counter (OTC) version of the OraQuick Advance Rapid HIV-1/2 test that is used in professional settings. The OraQuick Advance test is the first and only FDA-approved and CLIA (Clinical Laboratory Improvements Amendments Act of 1988)-waived rapid point-of-care test that can detect antibodies to both HIV-1 and HIV-2 in oral fluid in 20 minutes, OraSure noted.
If approved, the test would be the first-ever OTC, completely in-home HIV test, Reuters reported. According to the news agency, OraSure expects the product to have a retail cost of less than $60 if it is approved and to be marketed in the next several months.
BPAC members urged OraSure to conduct postmarketing studies to ensure that the test is available to underserved populations, according to Reuters. The news agency added that some panel members also called for "strongly worded labeling" about the possibility of false results and procedures to help connect people who call a company hotline with questions to health care professionals.