James A. Boiani, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Bloomberg Health Law & Business, in “Covid Test Makers Told to Update Labeling in Wake of Mutations,” by Allie Reed. (Read the full version – subscription required.)

Following is an excerpt:

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 FDA has been monitoring how tests will be affected by variants “throughout the pandemic,” according to a January press release. The agency has already pointed out four molecular tests that could be adversely impacted by viral mutations.

“If it turns out that certain tests are ineffective or inaccurate with regard to specific dominant strains” like the delta variant, “potentially, you would see the FDA withdrawing authorization,” said James Boiani, member of Epstein, Becker & Green PC.

It’s too soon to say whether the revision will exacerbate the shortage of Covid-19 tests resulting from the delta variant, Boiani said. …

Test makers have three months to update their labeling. They are expected to evaluate the affect of viral mutations “on an ongoing basis,” the letter stated.

The new wording would state that “performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARS-CoV-2 and their prevalence, which change over time,” the letter said.

“People should be able to know what exactly the performance of the test will be,” Boiani said.

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