FDA approved the Premarket Approval application for xT CDx, a 648-gene next-generation sequencing test for solid tumor profiling, which includes microsatellite instability status and companion diagnostic claims for colorectal cancer patients.
FDA Center for Drug Evaluation and Research is soliciting grant applications from independent organizations to support meetings that bring together a broad range of stakeholders to explore, research, and address issues related to medical products, policy, and surveillance methods and systems.
