FDA launches pilot program for certain LDTs for cancer patients

The Food and Drug Administration June 20 released guidance on a new voluntary pilot program intended to improve certain laboratory-developed tests used to identify patients for treatment with certain oncology drug products. The program will ask drug makers to provide performance information for the tests used to enroll patients in clinical trials for their drug, which FDA will use to post recommended minimum performance characteristics for similar tests to select patients for treatment with the approved drug. 
 
“We believe this guidance and the launch of the pilot program are important steps towards addressing safety risks posed by the use of poorly performing laboratory developed tests,” said Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “The pilot aims to help by making transparent performance recommendations for diagnostic tests used to select certain oncology drug treatments.”