Covid Test Makers Told to Update Labeling in Wake of Mutations (1)

Covid-19 test makers must consider the impact of viral mutations on the performance of their test, according to an FDA letter revising conditions of authorization for tests under an emergency use authorization.

The revision applies to molecular, antigen, and serology tests under EUAs, but not to standalone home collection kits. Test makers will have to update the labeling on their test outlining how viral mutations could impact the performance of their tests.

“The SARS-CoV-2 virus has mutated over time, resulting in genetic variation in the population of circulating viral strains over the course of the COVID-19 pandemic,” according to the ...