Becton Dickinson (NYSE:BDX) said today that it has stopped selling a point-of-care test touted as being able to detect antibodies to COVID-19 in as little as 15 minutes.
The test, by BioMedomics, was one of about 100 serological tests that the FDA allowed manufacturers to sell beginning March 26, 2020, if the companies self-validated their accuracy. The agency did not require the companies to submit reports of the results of their validation efforts.
More than 100 such self-validated tests have been on the market, raising concerns about their accuracy from the U.S. House of Representatives Oversight Subcommittee on Economic and Consumer Policy, the American Medical Association, the National Institutes of Health (NIH) and a group of independent scientists, which found that a number of serological tests for COVID-19 are performing poorly or inconsistently.