FDA Expedites Coronavirus Testing Kits
The agency takes other steps to make COVID-19 tests more available.
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.
Related: Top 3 Things to Know About Coronavirus Treatments
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.
Related: FDA, FTC warn suppliers of fraudulent COVID-19 products
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.
Read more: More Ranitidine Recalled, Plus Another Big Drug Recall
Conversations With Perry and Friends: Paul Fronstin, Ph.D.
May 9th 2025Perry Cohen, Pharm.D., a longtime member of the Managed Healthcare Executive editorial advisory board, is host of the Conversations with Perry and Friends podcast. In this episode, his guest is Paul Fronstin, Ph.D., director of health benefits research at the Employee Benefit Research Institute.
Listen
Fierce Debate Breaks Out Over GOP Bill That Could Strip Millions of Medicaid Coverage
May 13th 2025A Republican-led bill aiming to tighten Medicaid eligibility and impose work requirements sparked heated protests and clashes amongst House parties, with critics warning it could leave millions without health coverage.
Read More
Conversations With Perry and Friends
April 14th 2025Perry Cohen, Pharm.D., a longtime member of the Managed Healthcare Executive editorial advisory board, is host of the Conversations with Perry and Friends podcast. His guest this episode is John Baackes, the former CEO of L.A. Care Health Plan.
Listen
