Rep. Raja Krishnamoorthi, chairman of the House Subcommittee on Economic and Consumer Policy, is putting heat on the heads of the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) over the policing of inaccurate blood-based serology tests for coronavirus that have hit the market following the FDA’s decision to allow labs and commercial manufacturers to develop and distribute the 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,” Rep. Krishnamoorthi said.
“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,” he added.
Rep. Krishnamoorthi also sent letters to the CEOs of four companies marketing tests — BioMedomics Inc., Premier Biotech Inc., UCP Biosciences Inc., and Epitope Diagnostics Inc. — informing them that their tests were not on the FDA’s Pathway D policy list which allows manufacturers to distribute the coronavirus serology tests.
Rep. Krishnamoorthi stressed concerns that the FDA’s lax approach was allowing a “flood” of fraudulent tests onto the market. Case in point: data from a study of 14 serology tests found that 11 did not provide consistently reliable results.
“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,” Rep. Krishnamoorthi said.