The U.S. Food and Drug Administration has released new guidance for emergency use authorization for molecular-based laboratory developed tests that detect the coronavirus that's causing the global epidemic.
Under the guidance, molecular-based LDTs for qualitative detection of nucleic acid from SARS-CoV-2 in respiratory specimens 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 a request for the test 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 test on patient samples as soon as they are validated internally if they have notified the agency and file an EUA application within 15 days.
Yale New Haven Hospital's Clinical Virology Laboratory was granted emergency approval for its COVID-19 RT-PCR test under the new guidance on Tuesday.
This story first appeared in our sister publication, Genomeweb.