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- FDA Issues New Test Guidance for Viral Mutations of COVID-19
On February 23, the FDA issued new guidance for evaluating the impact of viral mutations on COVID-19 tests. Test developers can use the new guidance during the development and post-authorization of their COVID-19 tests for emerging and future variants. The FDA guidance is for COVID-19 molecular and antigen tests that detect the SARS-CoV-2 virus and serology tests that detect antibodies to the virus.
In summary, the new FDA guidance:
- Applies to COVID-19 test developers of molecular and antigen diagnostic tests, and serology tests issued an Emergency Use Authorization (EUA), COVID-19 test developers that are offering their tests as outlined in the FDA’s testing guidance, and COVID-19 test developers pursuing an EUA from the FDA.
- Provides recommendations on information to include in EUA requests or supplemental EUA requests.
- Describes the FDA’s activities to understand better the public health impact of new virus variants and the potential impact on authorized COVID-19 tests.
This policy will remain in effect for the duration of the public health emergency.