FDA Pandemic Response: States Can Now Approve COVID-19 Diagnostics, Serology Testing

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The FDA today took unprecedented measures to expand coronavirus disease 2019 (COVID-19) diagnostics testing capacity by modifying policy originally issued on Feb. 29 which addresses laboratories and commercial manufacturers to expand the number and variety of diagnostic tests, as well as available testing capabilities in health care settings, and reference and commercial laboratories.

Under the expanded policy, states may now take responsibility for tests developed and used by laboratories in their states, similar to the action the FDA granted to the New York State Department of Health last week. States can set up a system in which they take responsibility for authorizing such tests and the laboratories will not engage with the FDA. Laboratories developing tests in these states can engage directly with the appropriate state authorities, instead of with the FDA and are not required to pursue an Emergency Use Authorization (EUA) with the FDA.

The updated policy also provides recommendations for test developers who may wish to develop serological tests for use during this coronavirus outbreak. Serological tests measure the amount of antibodies or proteins present in the blood when the body is responding to a specific infection.

“We recognize that serology tests are less complex than molecular tests and are solely used to identify antibodies, which limits their effectiveness for diagnosis; however, as stated in the updated guidance, the FDA does not intend to object to the distribution and use of serology tests to identify antibodies to SARS-CoV-2 where the test has been validated, notification is provided to the FDA, and warning statements are included with the tests, for example, noting the test has not been reviewed by the FDA and results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.”

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