SARS-CoV-2 viral mutation prompts FDA alert for health care provider, clinical laboratory staff

The Food and Drug Administration today alerted clinical laboratories and health care providers of its ongoing effort to monitor the potential molecular test impact resulting from SARS-CoV-2 mutations, including the B.1.1.7 variant that has emerged from the United Kingdom.

FDA said that the risk that these mutations will impact overall testing accuracy is low. Nevertheless, the agency is working with authorized test developers and reviewing incoming data to ensure that health care providers and clinical staff can quickly and accurately diagnose patients infected with SARS-CoV-2, including those with emerging genetic variants.

The agency said that available data suggest that the two currently authorized COVID-19 vaccines may still be effective against mutated strains, including B.1.1.7., and will continue to keep health care providers and the public informed of any new information as it becomes available.