Senators Wary of FDA Ability to Regulate Laboratory-Developed Tests

Several senators expressed doubts that the FDA should take on the regulation of tens of thousands of laboratory-developed tests currently being used across the country, during a committee hearing on the future of regulation in an age of precision medicine.

“Is there anybody here that believes that the FDA architecture or the FDA talent exists today to be able to handle the processing of an [LDT] application, or an approval three years from now?” asked Sen. Richard Burr (R-N.C.), during a Sept. 20 hearing of the Senate Health, Education, Labor and Pensions Committee.

Currently, most tests that are developed and used within a single facility are regulated by the Centers for Medicare & Medicaid Services, through their standards and certification of clinical laboratories. This can include in vitro diagnostics, blood tests, and assays evaluating whether a patient will respond to a specific drug.