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FDA Releases New EUA Guidance for MDx Labs Offering SARS-CoV-2 Testing

NEW YORK – The US Food and Drug Administration on Tuesday released new guidance for Emergency Use Authorization for molecular-based laboratory developed tests (LDTs) detecting SARS-CoV-2. 

Under the guidance, molecular-based LDTs for qualitative detection of nucleic acid from SARS-CoV-2 in respiratory specimens that are authorized for use by the developing laboratory can be performed, but only in the CLIA-certified laboratory in which the test was developed.  

Tests are eligible for authorization under the EUA if the lab has submitted an EUA request for the LDT with required data, and if they are either new and not covered at the time of the EUA request or significantly different from an existing EUA-authorized test. The test must also be a reverse transcription PCR test using authorized material components and control materials.

The new guidance follows the FDA's pathway "Policy A," which allows labs to use validated SARS-CoV-2 LDTS on patient samples as soon as they are validated internally if they have notified the FDA and file an EUA application within 15 days. 

Yale New Haven Hospital's Clinical Virology Laboratory was granted an EUA for its SARS-CoV-2 RT-PCR test under the new guidance on Tuesday.