First Enforcement Action for Improper Marketing of SARS-CoV-2 Antibody Tests

After initially allowing producers of serologic SARS-CoV-2 antibodies tests free access to the market, the US Food and Drug Administration (FDA) is now cracking down on unproven and inaccurate tests. No More Mr. Nice Guy The turning point came in early May when, in response to heavy criticism and a scathing Congressional investigational report, the FDA withdrew its controversial “Policy D” allowing the marketing of SARS-CoV-2 antibody tests upon internal self-validation without need for Emergency Use Authorization (EUA), demanding that producers submit their tests to a federal laboratory for independent evaluation. Less than two weeks later, nearly 30 Policy D tests were delisted and/or voluntarily withdrawn by their manufacturers. On June 16, the agency revoked the EUA of one of the first serologic SARS-CoV-2 antibody tests to receive authorization, Chembio Diagnostic’s DPP COVID-19 IgM/IgG test, citing concerns about its sensitivity and specificity. According to the agency, Chembio and independent laboratory evaluation data showed that the test “generates a higher than expected rate of false results and higher than that reflected in the authorized labeling for the device.” The Warning Letters But until now, the agency had not initiated any enforcement action—even though it recognized almost immediately that test makers were […]