The US Food and Drug Administration will now require antibody test makers to promptly seek FDA authorization, as the agency aims to rein in unproven and fraudulent tests that have flooded the market.
The new policy, announced today, requires commercial manufacturers to submit emergency authorization requests, along with validation data for their antibody tests, within 10 business days. The FDA is also setting specific performance recommendations for all test developers.
The agency also said it has the capability, working with the National Cancer Institute, to independently validate antibody tests on the market.
Why this matters: The move to require authorization reverses a policy the FDA put in place in mid-March, which loosened approval standards and allowed companies to sell antibody tests, also known as serological tests, without providing evidence that the tests worked. It quickly became clear that many of the tests were unreliable and some companies marketed tests that they falsely claimed were FDA-approved or FDA-authorized or claimed the antibody tests could be used to diagnose Covid-19.
More context: Antibody tests are used to check for prior Covid-19 infection and can provide a better sense of how much of the population has already been infected and might have some immunity to the virus. It’s still not clear whether the presence of antibodies means someone is immune or how long that immunity might last.
To date, at least 10 antibody tests have been authorized under an individual EUA, most within just the past few days, and over 200 antibody tests are currently the subject of a pre-EUA or EUA review.