FDA Panel Backs OraSure's In-Home HIV Test

A panel of outside experts voted unanimously on Tuesday to recommend that the Food and Drug Administration approve OraSure Technologies Inc.'s OraQuick In-Home HIV Test. The 17-member FDA advisory committee said the benefits of people knowing their HIV status -- and seeking treatment, if positive -- outweigh the risks of false results.

If approved, OraQuick would be the first over-the-counter, at-home HIV test. OraSure said it will likely retail the test for less than $60.

Panel members called on the company to conduct post-marketing studies to ensure OraQuick is accessible by under-served populations in a way that links testers to services, including confirmatory follow-up for those who have a positive result. Some of the experts urged clear labeling about false results; another concern was linking consumers who phone OraQuick's hotline with questions to health care professionals

The panel heard supportive testimony from more than two-dozen witnesses including HIV/AIDS activists and representatives from the African-American community and public health. OraQuick could help eliminate HIV stigma, a key barrier to testing, by being available just like other home testing kits at a local pharmacy, they said. Some of those testifying received money or assistance from OraSure.

FDA officials said the test was highly effective at detecting HIV infection, but some data indicated OraQuick lacks sufficient sensitivity to avoid false-negative results. One witness called on the agency to withhold approval until additional studies can raise the test's accuracy to a standard in line with clinical settings.

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