FDA Releases Changes to Policy Requiring Manufacturers to Submit Antibody Testing Data

The 💊Food and Drug Administration (FDA) is cracking down on commercial manufacturers of serology tests, now requiring them to submit data to prove the accuracy of their antibody test results.

On Monday, the FDA rolled out its new policy which requires antibody test manufacturers to submit an emergency authorization request, along with validation data for their tests. Manufacturers will be required to do so within 10 business days.

The FDA’s decision to require authorization comes weeks after the federal agency loosened its approval requirements to allow companies to sell antibody tests without providing proof of accuracy or effectiveness.

As the coronavirus rapidly spread throughout the United States in mid-March, the government prioritized the circulation of the tests which are used to determine if a person was previously infected with the virus.

However, the FDA said “unscrupulous actors” were selling testing kits that did not work to “take advantage” of Americans.

“We, unfortunately, see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety,” Dr. Anand Shah, the FDA’s deputy commissioner, wrote.

FDA Commissioner Dr. Stephen M. Hahn released a statement about the evolution of their processes to ensure accurate data is collected.

“We are continuing to adapt our approach based on real-world experience and data and so, as FDA has authorized more antibody tests and validation data have become available, including through the capability at NCI, the careful balancing of risks and benefits has shifted from where it was in mid-March,” Hahn said. “This has all informed the changes to our policy regarding antibody tests.”

The crackdown on antibody tests comes at a time when it is critical for global health experts to get a better idea of how much of the population has already been infected.

A recent report of widespread testing in prison systems across four states uncovered a staggering 96% of roughly 3,300 inmates who tested positive COVID-19 cases that showed no symptoms.

At the time, Dr. Leana Wen noted that the results signaled the possibility of a “‘severe undercount’ in coronavirus cases due to asymptomatic carriers.”

The use of effective antibody tests could offer a more accurate look at the virus and likely assist with how states should proceed, going forward.