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FDA Revises SARS-CoV-2 Test Emergency Use Authorization Requirements to Account for Variants

NEW YORK – The US Food and Drug Administration on Thursday released additional conditions of authorization for certain SARS-CoV-2 tests that have received Emergency Use Authorizations, requiring test makers to update authorized labeling and evaluate the impact of variants on test performance.

The agency also issued recommendations to clinical laboratories and healthcare providers using the tests that the FDA said could be impacted by SARS-CoV-2 mutations.

In a letter establishing additional Conditions of Authorization on certain molecular, antigen, and serology tests for SARS-CoV-2, the agency is requiring developers to update authorized labeling within three months, submit the updates to the FDA as a supplement to the EUA, and evaluate the impact of viral mutations on test performance.

For multianalyte tests, developers must evaluate the impact of SARS-CoV-2 viral mutations and all other target analytes, the agency said. Evaluations must be ongoing and include any additional data analysis requested by the FDA in response to performance concerns. If viral mutations affect the expected performance of the test, developers are required to notify the agency immediately.

In addition, test labels must be updated within seven calendar days to include additional labeling risk mitigations if requested by the FDA.

The revisions aren't required for IL-6 tests, standalone specimen collection devices, or standalone home collection kits.

The FDA also reiterated its list of authorized molecular tests whose performances could be impacted by viral mutations.

Those tests are: Mesa Biotech's Accula SARS-CoV-2 Test; Applied DNA Sciences' Linea COVID-19 Assay Kit; Thermo Fisher Scientific's TaqPath COVID-19 Combo Kit; and Cepheid's Xpert Xpress SARS-CoV-2, Xpert Xpress SARS-CoV-2 DoD, and Xpert Omni SARS-CoV-2.

The FDA noted that the impact of mutations on these tests "does not appear to be significant" for overall sensitivity, but that it is providing the info "out of an abundance of caution." The Linea and TaqPath tests include targets that have reduced sensitivity, but both tests detect multiple targets.

For the Cepheid tests, the FDA said that two independent single point mutations reduce the tests' sensitivity for detecting the N2 target. While single point mutations generally won't impact performance for most molecular tests, the FDA said the impact of a single point mutation on the test performance is "associated with the unique chemistry of the Cepheid tests." It added that the impact on test performance didn't appear to be significant.

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