FDA Adcom Recommends OTC Diagnostics But Not for Flu

An FDA advisory committee unanimously recommended over-the-counter diagnostic assays for Chlamydia trachomatis/Neisseria gonorrhea and group A streptococcus, but said the risk outweighed the benefit for OTC flu diagnostics.

The Microbiology Devices Panel expressed concern that the potential low positive predictive value outside of the active flu season was a high risk and that risk was difficult to mitigate.