The U.S. Food and Drug Administration (FDA) has taken two additional significant diagnostic actions during the coronavirus outbreak (COVID-19) by issuing Emergency Use Authorizations (EUAs) to: Hologic for its Panther Fusion SARS-COV-2 Assay, and Laboratory Corporation of America (LabCorp) for its COVID-19 RT-PCR test.

“Staff at FDA have been working nonstop to expedite the review and authorization of diagnostics during this public health emergency,” said FDA Commissioner Stephen M. Hahn, MD, in a statement. “Our device center has been in continual contact with the medical device community, in particular diagnostic developers, since January — providing technical assistance to test developers to help facilitate the availability and distribution of tests so that health care professionals can accurately detect the COVID-19 virus. Since the beginning of this outbreak, more than 90 test developers have sought FDA guidance with the development and validation of tests they plan to bring through the EUA process. Additionally, more than 40 laboratories have notified us that they are testing or intend to begin testing soon under our new policy for laboratory-developed tests for this emergency. We stand ready to continue to support medical products in the pipeline to fight this virus.”

Regulatory Relief

FDA also updated a policy  originally issued on Feb. 29 on diagnostic testing for COVID-19 in order to achieve more rapid testing capacity in the United States. In a statement, FDA said it believes the unprecedented policy set forth in the updated guidance, which addresses laboratories and commercial manufacturers, will help address the urgent public health concerns by helping to expand the number and variety of diagnostic tests, as well as available testing capabilities in healthcare settings, and reference and commercial laboratories.

The agency 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, FDA says.

In the statment, Stephen Hahn, MD, FDA commissioner highlighted three key elements of the update.

  • FDA is putting in place a policy for states to 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. As stated in the guidance, the system does not need to mirror that of New York. Laboratories 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, FDA is expanding who the policy outlined in the Feb. 29 guidance applies to. The policy was originally applicable only to laboratories that are 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. 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, 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. As noted in the guidance, 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.
  • 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. 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.

FDA Support of Diagnostics

FDA says it has engaged with more than 100 test developers since the end of January, providing templates and advice about the EUA process. More than 80 developers have sought the agency’s assistance with development and validation of tests they plan to bring through the EUA process. FDA has granted multiple diagnostic EUAs during this outbreak.

FDA is updating its frequently asked questions for labs and test developers, providing information on alternative sources of reagents, extraction kits, swabs and more. It has set up a toll-free line, 1-888-INFO-FDA, to help labs with any questions they may have about the EUA process, FDA policies, or getting supplies.