FDA authorizes second genome sequencing test for SARS-CoV-2

Mar 30, 2021 - 02:46 PM
FDA-guidance

The Food and Drug Administration recently issued an emergency use authorization for a next generation sequencing test to detect SARS-CoV-2 in respiratory specimens from individuals suspected of COVID-19 by their health care provider.

Laboratories certified under the Clinical Laboratory Improvement Amendments to perform high complexity tests can perform the SARS-CoV-2 NGS Assay test. For more information, see the fact sheet for health care providers.

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