Shares in Grail surged after the FDA posted documents ahead of an advisory committee meeting on the company’s multi-cancer blood test, Galleri. The panel is scheduled for Wednesday, and the FDA is not bound by the committee’s advice but often takes cues from the review. Grail’s test is already available as a laboratory-based diagnostic, but FDA authorization would likely be pivotal for reimbursement and payer coverage, including Medicare. Market participants are watching the briefing materials for signals about performance and regulatory path ahead of the adcom discussion.
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