The FDA recently has named over dozen COVID-19 antibody tests that should be taken off the market a few weeks after the agency revoked its open-door policy on the coronavirus blood tests and asked the developers to submit their product details for a review. The 28 serology tests that are to be taken off include the ones that were voluntarily withdrawn by their sponsors as well as those that were neglected to pursue an official Emergency Use Authorization by the FDA. Under a policy that was put in place from mid-March to early May, the agency granted permission to more than 180 COVID-19 antibody blood tests to be sold and distributed in the U.S. without any kind of federal review but with certain stringent conditions for manufacturers.
The conditions were that they must notify the FDA about their plans, perform all the self-validation studies, and the product must carry a label saying that it is not authorized and is incapable of detecting the novel Coronavirus on its own. The FDA again changed this policy on the 4th of May, giving all the test makers with active products ten days to submit their applications for Federal review. The FDA stated that it is expecting the list of removed products to be updated in the near future. Until now, only 12 antibody tests have passed the emergency authorization process of the FDA. With the whole world going through a crisis, FDA has been working with over 400 test developers who have already submitted or at least have said that they will be submitting the EUA requests for the tests that can detect the coronavirus or any antibodies related to the virus.
B.D. and BioMedomics have recently stopped offering their test and are currently working on validating and submitting a new version of their serology test to the FDA. Meanwhile, Diazyme halted all its marketing and commercialization efforts for its aforementioned antibody test and has two EUA applications already undergoing an agency review for its IgG/IgM lab test.