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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.
The Friends of AIDS Foundation is
dedicated to enhancing the quality of life for HIV positive individuals and
empowering people to make healthy choices to prevent the spread of the HIV
virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.
TOGETHER WE REMAIN STRONG!
