FDA allowed both qualified and unqualified entities to flood the market with COVID-19 antibody tests, and the result was “chaos,” FDA’s former chief scientist Jesse Goodman told a U.S. House subcommittee.
A month after FDA tightened oversight of the tests and started withdrawing tests from the market, there is still enough concern about false results that the American Medical Association is recommending against people using the tests outside of certain settings, added Dr. Jesse Ehrenfeld, immediate past chair of the AMA’s board of trustees, speaking yesterday to the Subcommittee on Economic and Consumer Policy.
Rep. Raja Krishnamoorthi (D-Ill.), the subcommittee’s chair, faulted FDA for initially relying on self-validation from companies.
“FDA took companies at their word. When I ask my kids to clean their room, I can tell you my wife and I don’t rely on self-validation. However, that is the policy adopted by FDA until recently,” Krishnamoorthi said.
Goodman — who left FDA in 2014 to become the founding director of the Center on Medical Product Access, Safety and Stewardship (COMPASS) at Georgetown University — noted that FDA is now acting to correct the situation. Besides requiring serological test makers to submit for an emergency use authorization, the agency has also set up an independent performance validation study effort with the National Institutes of Health’s National Cancer Institute.
Experts testifying to the House subcommittee said FDA must quickly review unregulated tests and recall junk tests, with Goodman suggesting a prioritized review of “high risk” tests.
For now, the antibody tests’ main use should be for population-based prevalence tests, the experts told the panel.
AdvaMed’s AdvaMedDx division responded to the hearing by describing the serological tests as essential tools for clinicians and public health experts in maximizing diagnostic information to help prevent, detect and treat COVID-19.
“So far, more than a dozen commercial serology/antibody in vitro diagnostic tests have received EUAs. Diagnostic test manufacturers are delivering millions of these high-quality, highly sensitive and specific tests each month, and they are all validated to FDA’s exacting standards,” said Susan Van Meter, executive director of AdvaMedDx.