COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration

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FDA Issues Update on Its Support of Medical Products Affected by SARS-CoV-2 Variants

FDA maze of regulations

FDA addresses how clinical laboratories may be affected by SARS-CoV-2 variants and how the FDA is responding to these challenges

The US Food and Drug Administration (FDA) issued an update on its work to support medical products that could be affected by SARS-CoV-2 variants. This update addressed multiple areas of healthcare that could be affected by new viral variants, but specifically discussed therapeutics, diagnostics, and vaccines.

Clinical laboratories will be most affected by the FDA’s update on diagnostics. “We have been monitoring for new mutations, identifying and working with developers of tests whose performance may be adversely impacted by them, and communicating with the public when helpful information becomes available,” the FDA update says. “At this time, we believe the risk that the currently known mutations will impact overall testing accuracy of molecular tests is low. Moving forward, we are considering expanding the role of in silico monitoring by sponsors prior to and following authorization to assess for mutations that impact the performance of the test, test designs to minimize the impact of new mutations and ways to label authorized products to be transparent about what we know the test can detect.”

The FDA also addressed emerging evidence that virus-targeting monoclonal antibodies may be less effective against variants and concerns that new variants may eventually affect vaccine efficacy.

Clinical laboratory leaders wishing to view the FDA update in its entirety can do so here.

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