A House subcommittee is driving up pressure Wednesday on companies marketing coronavirus antibody tests that may fail to meet "a reasonable standard of accuracy."
Rep. Raja Krishnamoorthi (D-Ill.), chairman of the House Oversight subcommittee on economic and consumer policy, wrote to four companies — including one that's issuing tests in partnership with a major American medical tech company — requesting details of the firms' contact with the FDA, data supporting the accuracy of their tests and a list of medical facilities who have purchased test kits from the companies.
The outreach is part of Krishnamoorthi's investigation into the FDA's handling of the antibody tests, which are meant to help researchers determine the extent of the coronaviurs outbreak by finding people who have been exposed and may have developed immunity. It's a crucial datapoint for researchers as they seek to guide the U.S. coronavirus response and determine when it is safe to begin relaxing stringent social distancing and stay-at-home orders around the country.
"The Subcommittee is concerned that FDA is not conducting substantive review of serological tests that it has allowed on the market and that those tests may not meet a reasonable standard of accuracy," Krishnamoorthi said in the letters, which were sent to North Carolina-based BioMedomics, San Diego's Epitope Diagnostics, Minnesota-based Premier Biotech and San Jose's UCP Biosciences.
The FDA waived its typical quality checks to help antibody tests reach the market quickly, instead allowing companies to self-evaluate the accuracy of their products. Researchers have begun issuing evidence that many of the tests are falling short of typical accuracy standards, producing false positives that could lead people to believe they've developed protection against the virus.
Krishnamoorthi pointed to evidence obtained by University of California reseachers that tests marketed by the companies he's targeting fall short of the accuracy they claim in their marketing materials and instructions for use. In addition, UCP Biosciences has not been identified by the FDA as one of the 150 tests allowed on the market, yet its tests were purchased by a 25-bed hospital in rural Kansas, according to local reports.
An earlier staff report by the panel raised alarms about the lack of controls on the market for antibody tests, warning of "fraudulent" products and scolding the FDA for issuing "unclear guidance" while failing to police the market for these tests. And in a new letter to FDA Commissioner Stephen Hahn, Krishnamoorthi demands by May 6 information about the FDA's process for retroactively reviewing antibody tests that have come to market, whether any have met the agency's standards for approval and whether any have been removed or faced enforcement actions because they fell short.
Hahn last week acknowledged that the FDA is relying on companies' assurances that they verified their tests.
"What we’ve told manufacturers is that in order to market in the U.S., they have to validate their tests, they have to tell us that they validated their test, and then in the package insert they have to let people know — end users, labs, etc. — that those tests were not authorized by the FDA," he said at an April 24 coronavirus task force press briefing at the White House.
Hahn also told POLITICO that the agency is considering revising its policy toward the tests, attempting to balance quality with efforts to allow innovative products to reach consumers quickly in the midst of a crisis.
Krishnamoorthi's decision to include BioMedomics in his inquiry puts a major U.S. health care firm in the spotlight. BioMedomics recently partnered with BD, one of the country's largest medical tech manufacturers.
"The test does not require special equipment and may be used in a laboratory or at the point of care," the companies said in a March 31 announcement, adding, "Data on past exposure is important for researchers to more accurately understand the likely true occurrence of SARS-CoV-2 infection across a population. This information will be helpful in informing future strategies for combating COVID-19."
David Lim contributed to this story.
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April 29, 2020 at 05:20PM
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House investigators grill companies marketing questionable coronavirus antibody tests - POLITICO
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