FDA cleared two new coronavirus disease (COVID-19) tests via Emergency Use Authorization.
FDA Commissioner Stephen M. Hahn, MD, also outlined other ways the agency is working to get more tests available.
The agency expedited approval of Panther Fusion SARS-COV-2 Assay (Hologic), 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,” Hahn says in a press release. “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.”
More than 40 labs have notified FDA that they are testing or intend to begin testing COVID-19 assays, Hahn added.
In addition, FDA’s new policy will allow states to take responsibility for tests developed and used by laboratories in their states.
“States can set up a system in which they take responsibility for authorizing such tests and the laboratories will not engage with the FDA,” Hahn says in a separate press release.
FDA’s updated policy also provides recommendations for test developers that may wish to develop serological tests for use during the 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…” Hahn says.
FDA has engaged with more than 100 test developers since the end of January, providing templates and advice about the Emergency Use Authorization process.
“More than 80 developers have sought our assistance with development and validation of tests they plan to bring through the EUA process. We’ve granted multiple diagnostic EUAs during this outbreak,” he says said.