FDA Advisors Back 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.

The panel agreed that the FDA should evaluate and assess the performance of future OTC diagnostics for infectious diseases against nucleic acid amplification test comparators (NAAT). The panel also agreed that this test method should be used to evaluate assays for influenza and CT/NG.

The device panel also recommended risk mitigation statements that should be included in the package insert for the OTC tests regarding follow up and interpreting results.