Dozens of Virus Antibody Tests Lacking FDA Vetting Will Exit Market

(Bloomberg Law) -- The U.S. Food and Drug Administration said on Thursday that 27 coronavirus antibody tests will no longer be distributed in the U.S., as part of a previously-announced crackdown by the regulator on the tests.

Antibody tests look for markers in the blood that indicate exposure to the novel coronavirus, but, in contrast with diagnostic tests, can’t determine whether a patient has an active Covid-19 infection. The FDA’s stricter stance on antibody tests follows an initially permissive policy that allowed hundreds of antibody tests to be sold without the regulator’s oversight and prompted criticism about the tests having accuracy issues.

The 27 tests either didn’t seek authorization from the regulator or had “significant problems” identified with them, according to the FDA. Manufacturers voluntarily withdrew nine antibody tests, including one from BioMedomics, Inc., the FDA said. It also said that the list of removed antibody tests will likely continue to be updated.

FDA Commissioner Stephen Hahn said in a Thursday release that the news represented an important step “taken to ensure that Americans have access to trustworthy tests.”

The change is thanks to a policy change the agency made earlier this month that requires the agency to vet the data used to validate the accuracy of those tests.

Key to Reopening

These types of tests are meant to show whether someone has ever had Covid-19. Knowing who has already had the virus—and therefore might be immune to it in the future—is a crucial step in fully re-opening the economy, health officials say.

BioMedomics, Zhengzhou Fortune Bioscience Co., Lifeassay, and Promedical are among the manufacturers on the FDA’s new list of tests being pulled from the market until the agency gives them a special authorization to sell their products, called Emergency Use Authorization.

“FDA expects that the tests on this list will not be distributed unless and until an EUA is issued for the test, and FDA may take additional actions as appropriate,” the website notes.

Companies have been able to sell tests with limited accuracy data thanks to a policy the FDA set up in mid-March. That policy was intended to speed up test production and ramp up the nation’s testing capabilities. The FDA changed its policy in early May to make the test vetting procedure more strict following concerns of inaccurate test results.

“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,” Hahn said.

To contact the reporters on this story: Jacquie Lee in Washington at jlee1@bloomberglaw.com and Emma Courtin New York at ecourt1@bloomberg.net

To contact the editor responsible for this story: Fawn Johnson at fjohnson@bloomberglaw.com

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