FDA gets explicit about asymptomatic screening tests

FDA’s new guidelines on COVID-19 screening tests provide a clearer and more streamlined path for a product use case whose regulatory status has been largely out of alignment with its critical role in reopening.

On Tuesday, FDA issued a supplemental template for test developers seeking emergency use authorization (EUA) of tests for asymptomatic screening with serial testing. The agency also released a fact sheet for groups setting up serial screening programs that explains use cases for different types of tests. Serial testing overcomes one of the main hurdles for asymptomatic COVID-19 screening: the limited utility of a test that reflects only a single point in time...