FDA Updates Coronavirus Policy

The U.S. FDA has updated a policy originally issued on Feb. 29 on diagnostic testing for coronavirus (COVID-19) in order to achieve more rapid testing capacity in the U.S. The policy addresses labs 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 labs.

The FDA is urging state authorities and commercial developers to take all necessary steps to ensure the availability of accurate tests. Inaccurate diagnoses during a pandemic can impair prevention efforts and delay appropriate treatment for sick patients.

The guidance provides more specific details for the lab and commercial manufacturer communities and includes three key elements. A policy for states to take responsibility for tests developed and used by labs in their states. Labs developing tests in these states can engage directly with the appropriate state authorities, instead of with the FDA. Nor will these laboratories pursue an Emergency Use Authorization (EUA) with the FDA.

Second, the FDA is expanding who the policy guidance applies to. The policy was originally applicable only to labs certified to perform high-complexity testing consistent with requirements under the Clinical Laboratory Improvement Amendments. Under the update, the agency does not intend to object to commercial manufacturers distributing and labs using new commercially developed tests prior to the FDA granting an EUA, under certain circumstances.

Finally, the updated policy 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. 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.