Grail said it is preparing for a likely FDA advisory committee meeting after the company submitted its premarket approval application for Galleri, its blood-based multi-cancer early detection test. In a call discussing second-quarter results, CEO Josh Ofman said the FDA review could trigger outside experts given the potential public-health impact of multi-cancer screening. Grail also pointed to evolving evidence it plans to support the review, including data from the first 25,000 patients in PATHFINDER 2 and the first year of NHS-Galleri, plus analyses comparing performance of the version used in those studies with the updated test submitted to FDA. The company remains on track for a possible decision in early 2027. A key commercial theme was payor readiness: Grail executives said many employers and insurers are waiting for FDA approval before coverage decisions, describing the agency’s “gatekeeping” role for payor adoption of future MCEDs.