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OTC Tests For Flu, Strep, STIs Up For Discussion At FDA Panel Meeting

 
• By Elizabeth Orr

Panelists will look at the benefits and risks of over-the-counter diagnostics for influenza, strep throat and sexually transmitted infections. The meeting is being held in response to sponsor queries about new test designs.

An Aug. 16 US FDA advisory panel meeting could facilitate the pathway to market for over-the-counter (OTC) tests for the flu, strep throat and certain sexually-transmitted infections – if members of the agency’s Microbiology Devices Panel can agree on what safety precautions are needed.

Few diagnostics, and, in particular, infectious disease diagnostics, are currently available over-the-counter. One exception is OraSure Technologies Inc.’s OraQuick...

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