The FDA named more than two dozen coronavirus antibody diagnostics it says should be taken off the market weeks after the agency closed its open-door policy on COVID-19 blood tests and required developers to submit their products and data for review.
The 28 serology tests, mostly manufactured overseas, include ones that were voluntarily withdrawn by their sponsors as well as those that neglected to pursue an official FDA Emergency Use Authorization.
Under a policy in place from mid-March through early May, the agency allowed over 180 antibody blood tests to be sold and distributed in the U.S. without federal review but with certain conditions for manufacturers: They must notify the FDA of their plans, perform self-validation studies and carry a label saying the product is not authorized and incapable of diagnosing COVID-19 on its own.
The FDA changed its policy May 4, giving test makers with active products 10 days to submit applications for review. The agency said it expects its list of removed products to be updated in the future.
“Our action today is an important step the agency has taken to ensure that Americans have access to trustworthy tests,” FDA Commissioner Stephen Hahn, M.D., said in an agency statement. “We have seen a high level of collaboration and engagement from developers who want to get this right, and we continue to be available to work extensively with industry to help them with developing accurate tests for the public.”
To date, 12 antibody tests have passed the FDA’s emergency authorization process, while the agency works with the National Institutes of Health and the Centers for Disease Control and Prevention to independently validate certain serology tests.
During this pandemic, FDA has worked with 400+ test developers who have already submitted or said they will submit EUA requests for tests that detect the virus or antibodies to the virus, & authorized 105 tests under EUAs: 92 molecular tests, 12 antibody tests & 1 antigen test.— Dr. Stephen M. Hahn (@SteveFDA) May 22, 2020
The list includes tests made by Beverly Hills, California-based Vita Testing; Diazyme Laboratories, a subsidiary of defense contracting giant General Atomics; the San Diego-based drug testing laboratory company Phamatech; and BioMedomics, which developed a rapid fingerstick test formerly sold by BD.
According to a recent report from MassDevice, BD and BioMedomics stopped offering the test earlier this month and is currently working to validate and submit a newer version of its serology test to the FDA.
Diazyme, meanwhile, previously halted commercialization efforts for its aforementioned rapid antibody test, and currently has two EUA applications undergoing agency review for a high-throughput IgG/IgM lab test.
Editor's note: This story has been updated to clarify Diazyme's multiple testing efforts. Additionally, this story has been corrected to note that it is the San Diego-based Phamatech, not Caris Life Science's Pharmatech, that has had a test delisted.