Congressman Krishnamoorthi Seeks Information On Coronavirus Blood-Based Serology Tests From CDC And FDA
WASHINGTON, DC – Following an FDA decision permitting labs and commercial manufacturers to develop and distribute blood-based serology tests for coronavirus without requiring FDA review, Congressman Krishnamoorthi (IL-08), as Chairman of the House Oversight Subcommittee on Economic and Consumer Policy, wrote to CDC Director Dr. Robert R. Redfield, and FDA Commissioner Dr. Stephen M. Hahn, requesting information on how they plan to regulate and review such tests.
“While serology tests are useful in determining if an individual with coronavirus has recovered by identifying antibodies left behind in their blood, they have not yet proven reliable enough for actually detecting whether or not an individual is infected with the virus,” said Congressman Krishnamoorthi. “In fact, we are already seeing instances where companies are misleadingly marketing serology test kits and implying they can be used to help people find out whether or not they are infected with coronavirus—and some are being marketed for home use, even though FDA has not approved any at-home testing. As aggressive as we must be in developing innovative testing solutions to combat the spread of this deadly disease, we must also protect American consumers from needlessly spending their hard-earned money towards ineffective solutions rushed to market with little to no regulatory oversight. As Chairman of the Oversight Subcommittee with jurisdiction over public health issues, I am eager to work with federal regulators to preserve this delicate balance.”
Chairman Krishnamoorthi’s letters come as manufacturers have already begun taking orders to distribute serology test kits. Some companies have even started marketing them directly to consumers, claiming they can be performed at home, a practice that would violate FDA policy. Many of these tests are manufactured in China and have raised the concern of public health professionals for their inaccuracy as a test for coronavirus infection, and the false sense of security they produce.