FDA policy change to expedite availability of diagnostics for COVID-19

March 17, 2020

The FDA updated a policy originally issued on February 29 on diagnostic testing for coronavirus (COVID-19) in order to achieve more rapid testing capacity in the U.S., FDA Commissioner Stephen M. Hahn, MD, announced.

The FDA’s updated guidance, which addresses laboratories and commercial manufacturers, will allow them more latitude in expanding the number and variety of diagnostic tests, as well as available testing capabilities in health care settings, and reference and commercial laboratories, Hahn said.

Hahn said the FDA guidance contains three key elements:

First, the guidance allows states to take responsibility for tests developed and used by laboratories in their states, which is 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 or need to pursue an Emergency Use Authorization (EUA) with the FDA.

Second, the FDA expanded a policy originally outlined in the February 29 guidance by applying it to commercial manufacturers. The FDA now will allow them to distribute tests to labs before being granted an EAU.

The original policy was applicable only to laboratories that are certified to perform high complexity testing consistent with requirements under the Clinical Laboratory Improvement Amendments (CLIA).

“The FDA is aware that numerous commercial manufacturers are developing tests for coronavirus with the intention of submitting an EUA to the FDA. During this public health emergency, the FDA does not intend to object to the distribution and use of these tests for specimen testing for a reasonable period of time after the manufacturer’s validation of the test, and while the manufacturer is preparing its EUA request where the manufacturer provides instructions for use of the test and posts data about the test’s performance characteristics on the manufacturer’s website,” Hahn said in a statement. “As noted in the guidance, the FDA believes that 15 business days is a reasonable period of time to prepare an EUA submission for a test whose performance characteristics have already been validated by the manufacturer,” he said.

The third key element of the updated policy provides recommendations for test developers that want to develop serological test, which 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,” Hahn said.

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