FDA issues first Emergency Use Authorization for laboratory developed test for COVID-19 to Yale New Haven Hospital

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On March 31, 2020, the FDA issued an Emergency Use Authorization (EUA) for molecular-based laboratory developed tests (LDTs) for detection of nucleic acid from SARS-CoV-2 (Molecular LDT COVID-19) in specimens from individuals suspected of COVID-19 by their healthcare provider. Under this EUA, authorized tests are authorized for use in the single laboratory that developed the authorized test and that is certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a to perform high complexity tests. As of this date, FDA has been notified that more than 110 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.

The EUA sets forth several eligibility requirements, including that the test be a “typical real-time reverse transcription PCR test in which SARSCoV-2 nucleic acid is first extracted, isolated and purified from human respiratory specimens, using authorized extraction methods,” and then “reverse transcribed into cDNA followed by nucleic acid amplification and detection using an authorized detection instrument.” Test material components must either be designed and manufactured by the laboratory or represent commercially sourced materials, such as research use only (RUO) components from third party manufacturers and authorized ancillary reagents commonly used in clinical laboratories.

To be eligible for EUA, the test must also be “either new and not covered at the time of the EUA request by an existing commercially distributed EUA-authorized test” or must “represent[] a significant deviation from an existing commercially distributed EUA-authorized test,” in addition to not otherwise being currently marketed in the U.S.

On April 1, FDA authorized the first Yale New Haven Hospital’s SARS-CoV-2 PCR test —the first authorized Molecular LDT COVID-19 test. Yale’s assay is a real-time RT-PCR test that uses a TaqMan probe-based chemistry and targets the N1 and N2 nucleocapsid genes of the virus. RNA extraction is performed using the Nuclisens Easymag from BioMérieux and the test runs on the ABI QuantStudio Flex 6 Real-Time PCR System from Thermo Fisher Scientific. Under the EUA, only the Yale laboratory, a CLIA-certified high-complexity lab, is permitted to conduct the test.

Many commercial and healthcare system/academic laboratories have notified the FDA that they have validated their own COVID-19 test and have started patient testing as set forth in Section IV.A of the FDA's Policy for Diagnostic Tests for Coronavirus Disease-2019. As stated in that policy, for laboratories certified under CLIA to perform high-complexity testing, the FDA does not intend to object to the use of validated tests for specimen testing for a reasonable period of time after validation while the laboratory is preparing an EUA request.

Other than the Yale test, FDA has not yet reviewed test validations or issued EUAs for any laboratory that has submitted a notification to FDA or a Molecular LDT COVID-19 test.

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