FDA Committee Approves OraSure's Over-the-Counter, In-Home HIV Test
May 18, 2012
The first ever over-the-counter, in-home HIV test is one step closer to being sold on the market for consumers. The U.S. Food and Drug Administration Blood Products Advisory Committee (BPAC) panel of 17 experts unanimously concluded that the OraSure Technologies Inc's test, OraQuick, is reasonably safe and effective for determining someone's HIV status.
BPAC voted on two questions posed by the FDA:
The committee voted 17-0 affirmative to both questions.
The recommendations of the committee will now be reviewed by agency regulators.
AIDS United is supportive of OraSure's application for approval of the OraQuick over-the-counter, in-home HIV test. AIDS United's major recommendations include:
This article was provided by AIDS United. Visit AIDS United's website to find out more about their activities and publications.
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