Facing Fraud, U.S. FDA Resets Coronavirus Antibody Test Market Rules

May 4, 2020

(Reuters) – The U.S. Food and Drug Administration on Monday said it would require antibody tests for the new coronavirus to undergo an agency review, reversing an earlier policy that had allowed fraudulent products to be marketed. The agency’s previous policy required only that companies attest that their product was valid and labeled as unapproved, attracting 170 companies to the antibody test market including unscrupulous vendors making false claims, Reuters reported last week.