FDA reversing course on fast-track approvals for COVID-19 antibody tests

The FDA is walking back a policy that allowed many companies to market unvalidated and unreliable COVID-19 antibody tests.

In March, the FDA waived its rules requiring manufacturers and laboratories to undergo agency review before bringing their serological tests to market. Since then, more than 120 testing manufacturers and labs have begun marketing their serological tests without any form of FDA approval.

To date, only 12 of these labs and manufacturers have received an Emergency Use Authorization. This lack of oversight has caused confusion about the validity and proper uses of serology tests and likely led to many false results across the country.

In a letter sent to FDA Commissioner Stephen Hahn and U.S. Department of Health and Human Services Assistant Secretary for Health Brett Giroir, Reps. Abigail Spanberger and Don Beyer urged the FDA to conduct a thorough review of serology tests already on the market.

Additionally, they called on the FDA to streamline the process for serology tests developers to apply for an EUA, improve data collection on the accuracy of these tests, and clarify where serology tests can be performed and who can perform them.

Following this effort, the FDA yesterday revised its policy to now require all commercial serology test manufacturers to submit EUA requests within 10 days of notifying the FDA of their validation testing. Additionally, the FDA ordered all serology test manufacturers to provide data that confirms that these tests work.

“Unfortunately, the lack of a consistent strategy and weak oversight of the serology testing market has allowed misinformation to spread and caused a great deal of confusion in the public about the validity and uses of serology tests. Serology tests cannot be used to diagnose COVID-19, since antibodies may supervene infection by several weeks,” Spanberger and Beyer wrote in their letter to the FDA. “We also do not know if the presence of antibodies confers immunity to reinfection by COVID-19. And finally, there is the risk of false positives, which could encourage individuals to ease social distancing precautions while they are still vulnerable to infection. Yet, misinformation on all these points continues to plague Americans, including many local policymakers, business owners, or caregivers responsible for making decisions about the safety of others.”

The letter continues: “We appreciate the difficulty regulators face in balancing the benefits of allowing expeditious market access and the risks of foregoing important validation tests, especially in an urgent situation like the current public health emergency. Unfortunately, the balance represented by Section IV.D is allowing an unacceptable number of invalidated tests onto the marketplace, leading to further public mistrust and confusion.”

Spanberger and Beyer also called on the FDA to begin a publication education campaign about the accuracy of serology tests, as well as to design and implement a national COVID-19 testing strategy.