COVID-19 molecular tests that have already been authorized for individual use will have an easier time getting an FDA nod for pooled testing.
The FDA said today it will add tests by manufacturers who validated their nasal specimen test for pooling to its list of tests available for use with pooled nasal specimens. This could expand the number of tests that schools and employers can use to routinely screen asymptomatic individuals for SARS-CoV-2, the virus that causes COVID-19.
“The flexibility that the FDA has provided developers continues to be a hallmark of our approach to the COVID-19 pandemic and we will continue to prioritize authorization for tests with the ability to increase testing accessibility or to significantly increase testing capacity,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, in a news release. “The FDA is committed to assisting our schools, workplaces, communities and other entities with establishing effective testing programs as the national response to the COVID-19 pandemic continues to evolve.”
Test manufacturers who want to pool more than three specimens must submit their validation data and pooling procedures to the agency. The FDA will then add the test to its public list of tests authorized for pooled screening.
The move comes after the agency issued a new supplemental template last month for test developers seeking emergency use authorization of certain tests for screening with serial testing.