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FDA Issues Amendment to Streamline Authorization of Pooled Molecular COVID-19 Testing

NEW YORK – The US Food and Drug Administration on Tuesday issued an amendment streamlining the authorization process for pooled molecular COVID-19 testing.

The amendment will allow for many molecular COVID-19 tests that have received Emergency Use Authorization to be used as part of pooled assays within serial testing programs if the test developer has self-certified that it has validated the test for pooling.

To offer pooled testing under this amendment, test developers must submit a notification to FDA with required information including the validation data and the pooling procedures to be used, after which the test will be listed on the FDA website as allowed for pooling and updated labeling will be posted with the test's EUA. This, the agency noted, will allow organizations running serial testing programs to identify tests authorized for that purpose.

The amendment applies only to pooling of anterior nasal respiratory specimens and tests being used at least once per week as part of a serial testing program.