FDA Warns Against False Advertising for Covid-19 Antibody Tests

Dozens of companies making false claims about Covid-19 products meant to test if someone who has had the virus is now potentially immune to it face enforcement including possible product seizures, the FDA has warned.

Over 70 test developers have told the Food and Drug Administration they have these types of products—called serological tests— available. However, the agency has green lit only one company, Cellex Inc., through its emergency regulatory channel to use the tests in clinical labs. Going through that channel means the test has at least been reviewed by the FDA, that the agency believes it “may ...