The U.S. FDA's breakthrough devices program is starting to accumulate a significant number of designations, with the latest being an as-yet unnamed diagnostic system from Grail Inc., of Menlo Park., Calif. The company said it has several large studies underway for its next-generation DNA sequencing (NGS) system intended to provide for the early detection of a large number of cancers. This makes the system of interest not just for the FDA, but also for payers keen on diagnosing cancers early, when they are considerably less expensive to treat.