ARTICLE SUMMARY:
FDA has announced a voluntary pilot for oncology drug products and companion IVD tests. Excerpted from Pathways' Picks June 21: TCET Time, Cancer LDTs, Renal Denervation Panel, and More.
FDA says it will post minimum performance characteristics online for cancer drug companion diagnostics that it hopes laboratories will use to develop the higher quality tests under a pilot launched this week. The performance data will come from participating drug manufacturers who provide information about tests used to enroll patients into the clinical trials that support drug approval. The goal is to improve the performance of available laboratory developed tests (LDTs) in situations when FDA approves an oncology drug that requires a companion diagnostic to inform therapy but the agency hasn’t approved such a test. Up to nine pharmaceutical companies can volunteer to participate in the pilot. FDA says will choose participants over the next year, and the minimum LDT performance characteristics will be posted online when each drug is approve. In parallel to the pilot, FDA is working on a proposed regulation that would subject LDTs to more routine FDA premarket review.