By Caroline Humer and Carl O’Donnell
(Reuters) – The U.S. Food and Drug Administration on Thursday identified 27 coronavirus antibody tests that should no longer be sold in the United States, following up on new regulations meant to weed out dubious tests and players that had entered the country under loose rules set in March.
That original policy required vendors only to notify the agency that they intended to sell the tests in the country and to self-certify the tests worked. Reuters reported that the policy had opened the market to fraud and lawmakers had pushed the FDA to change it.
The antibody tests are used to determine if a person has been previously exposed to the new coronavirus and developed antibodies that could prevent reinfection. Federal, state and local governments are deploying these tests to gauge the level of immunity in populations.
Under the abridged rules announced May 4, vendors must apply for emergency FDA authorization for the test within 10 days of the rules change, or within 10 days of notifying FDA of the intent to sell new tests.
The FDA website had previously listed more than 200 companies that intended to sell antibody tests, more than half of which were from China. Some European countries had complained that certain Chinese antibody tests were inaccurate.
The FDA’s list of tests no longer allowed on the market includes those from vendors who voluntarily withdrew and those for which there is not a pending request for the emergency use authorization, the agency said. (https://reut.rs/3cRSUYP)
Subsequent to the new guidance, Becton Dickinson and Co suspended distribution of an antibody test they have been distributing since late March in partnership with diagnostics company BioMedomics.
“BioMedomics has completed development of a second generation of the test… [and] intends to submit a new EUA application to FDA once the second-generation test has successfully completed all validation testing,” Becton Dickinson said last week in a statement.
(Reporting by Caroline Humer and Carl O’Donnell in New York and Manojna Maddipatla in Bengaluru; Editing by Aditya Soni and David Gregorio)