OraSure Technologies, Inc. (OSUR) said Wednesday that the U.S. Food and Drug Administration Blood Products Advisory Committee will consider the company's application for the approval of its OraQuick Rapid HIV-1/2 test for sale in the U.S. consumer or over-the-counter market at a meeting scheduled for May 15.
The company said it will be presenting the findings from the final phase of clinical testing, which involved the use of the OraQuick In-Home HIV Test, an OTC investigational use version of the OraQuick ADVANCE Rapid HIV-1/2 test, by individuals in an unobserved setting.
About 5,800 subjects were enrolled and tested in this phase across 20 sites nationwide, resulting in the identification of more than 100 previously undiagnosed individuals with HIV, the company said.
by RTT Staff Writer
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