Reliable Next-Gen Data May Avert FDA Review, Shuren Says

Formal FDA review may not be needed for interpreting results of advanced genetic screening tests if the associated databases contain reliable information, the agency’s device chief said.

Jeffrey E. Shuren, director of the Center for Devices and Radiological Health, made the remarks while explaining the Food and Drug Administration’s plan to regulate next-generation sequencing tests. These diagnostic tests, which can screen an entire genome to detect variations linked to diseases, are considered critical to the White House’s precision medicine initiative.

“The linchpin for precision medicine—getting the right treatment to the right patient at the right time—is the diagnostic,” ...