FDA's Pilot Program Aims to Reduce Risks of Cancer Biomarker Tests.

The FDA has launched a voluntary pilot program for certain oncology drug products used with certain corresponding in vitro diagnostic tests to help clinicians select appropriate cancer treatments for patients. The pilot program aims to reduce the risk of using poorly performing laboratory developed tests (LDTs) for oncology drug treatment decisions. The FDA will request performance information for the tests used to enroll patients into the clinical trials that support drug approval and post the minimum performance characteristics recommended for similar tests that may be used to select patients for treatment with the approved drug on the FDA website.