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- FDA Launches Cancer Biomarkers Pilot
The U.S. Food and Drug Administration (FDA) announced a new 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. According to the FDA, the pilot will increase the transparency and safety of diagnostic tests used to select certain oncology drug treatments.
Through the pilot program, the FDA will request, from drug manufacturers, performance information for the tests used to enroll patients into the clinical trials that support drug approval. Based on an assessment of that information, the FDA will post to the FDA website the minimum performance characteristics recommended for similar tests that may be used to select patients for treatment with the approved drug. Laboratories may use this information to guide their development of laboratory-developed tests (LDTs) to identify specific biomarkers used for selecting cancer treatment. This transparency aims to help facilitate better and more consistent performance of these tests, resulting in better drug selection and improved care for patients with cancer. The initial phase of the pilot program is anticipated to last up to one year.