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Previewing policy changes for antigen tests and monkeypox products

At a monthly town hall with FDA Diagnostics Office leadership, regulators talked about upcoming changes to the expectations for Covid-19 antigen tests and previewed a potential policy shift for monkeypox products.

The main update at the August town hall was a preview of impending antigen test policy changes.

  • Antigen tests and sensitivity; Early in the pandemic, the FDA established that the relative lower sensitivity associated with at-home antigen tests could be offset through a serial testing strategy. In effect, the agency has allowed over-the-counter (OTC) antigen tests for Covid-19 to be authorized even with a lower sensitivity per administration of the test, so long as the cumulative sensitivity of multiple tests undertaken in a set amount of time would meet the agency’s performance baseline.

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