The Trump administration has revoked the FDA’s authority over lab-developed tests, including requirements that certain diagnostics made for COVID-19 go through the agency’s emergency review and authorization process, according to a U.S. Department of Human Services statement. The change affects tests assembled and used within a single, certified laboratory such as those developed by Madison-based Exact Sciences.
These labs can greatly vary in size and throughput, and include small hospitals and the largest academic medical centers and health systems in the country. Since late March, the FDA has granted emergency use authorizations (EUA) to 35 lab-developed molecular diagnostic tests for COVID-19 — including to the virology laboratories at Yale, Northwestern, and Stanford, as well as the Mayo Clinic, Massachusetts General Hospital, Cedars-Sinai, and Exact Sciences. Labs with an EUA already granted by the FDA are unaffected by this change in governance.
