FDA Issues Alert on SARS-CoV-2 Viral Mutations and the Associated Impact on Testing

The U.S. Food and Drug Administration (FDA) is closely watching SARS-CoV-2 viral mutations, specifically the B.1.1.7 variant emerging out of the United Kingdom and evaluating the potential effects on authorized molecular tests. The agency cautions molecular tests for SARS-CoV-2 that assess the virus’s genome can generate false negatives if the viral strain is modified.

As evidenced by B.1.1.7, SARS-CoV-2 is mutating and introducing new variants into the population. The FDA believes the risk that these mutations will impact overall testing accuracy is low, but as outlined by Commissioner Stephen Hahn, it will continue to monitor genetic viral variants to ensure reliable test results for patients.

The agency notes that current data demonstrates the approved COVID-19 vaccines may still be effective against this strain.

The FDA will communicate developments related to virus mutations as new information becomes available. The agency asks healthcare providers to report adverse events or suspected adverse events linked to molecular tests for detection of COVID-19 via MedWatch, the FDA Safety Information and Adverse Event Reporting program. 

Due to evolving evidence, our insured clinicians are advised to monitor ongoing FDA guidance pertaining to testing, transmission and treatment of COVID-19. Additionally, MLMIC has assembled a number of critical resources to support New York physicians as they navigate the pandemic. This information, which includes the latest developments in medicine and government, can be accessed on our website.