November 18, 2009

OraSure’s Over-the-Counter HIV Test One Step Closer to FDA Approval

On November 18, OraSure Technologies Inc. announced that it took part in a Blood Products Advisory Committee (BPAC) meeting—held the previous day—to discuss, among other topics, the public need and performance characteristics for over-the-counter (OTC) home use HIV test kits. The BPAC gives advice to the U.S. Food and Drug Administration (FDA) on issues pertaining to the safety and effectiveness of biological products and medical devices.

During the meeting, OraSure participated in a closed session with the BPAC to review results of continuing clinical studies on its OraQuick HIV OTC test, in addition to the necessary clinical work required for FDA approval of the assay. Based on feedback from the BPAC, OraSure will continue seeking FDA approval for the test.

“We are very pleased to have had the opportunity to discuss our ongoing clinical efforts for at-home HIV tests with the Blood Products Advisory Committee,” OraSure Technologies president and CEO Douglas A. Michels said in a statement. “We are gaining greater clarity as to the additional steps for this clinical program and intend to work closely with the FDA to define and execute the remaining studies required for approval.”

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Frederick Wright, Tampa, 2009-11-23 09:39:56
Again, a dog and pony show for Oral Sure's investors and our Big Cat Government. Where is the CDC in this picture and why is the FDA in the mix for the test has be Waved like most over the counter screening kit , example, Pregnancy Test, Diabetes Testing, .... Once waived always waived.. put the product in the stores and see what happens, like one less new HIV case and one more….. If this was a Flu Test we would not be having this debate or lack debate.