US targets fraud in coronavirus antibody test market with tighter rules

The FDA said it would share information on its website and with potential buyers of these tests

The United States on Monday began requiring antibody tests for the new coronavirus to undergo a regulatory agency review, acknowledging that its earlier policy had opened the door to fraud.

The US Food and Drug Administration had previously required only that companies attest 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.

When the FDA put the policy in place on March 16th, it had been under pressure to move fast following a slow ramp up of Covid-19 diagnostic tests that hindered public health efforts.

"Flexibility