OraQuick(R) In-Home HIV Test Receives Unanimous Positive Recommendation From FDA Advisory Committee
OraSure Technologies, Inc. (Nasdaq:OSUR - News) today announced that the U.S. Food and Drug Administration (FDA) Blood Products Advisory Committee (BPAC) provided a unanimous positive recommendation for the Company's OraQuick(R) In-Home HIV Test. The BPAC provides advice to the FDA on issues related to the safety and effectiveness of biological products and medical devices seeking FDA approval.
The BPAC voted on two questions posed by FDA:
Do the projected benefits of the test outweigh the potential risks of false positive and false negative test results?
- Published: 16 May 2012
- Written by Editor