Grail shares jumped 35% after U.S. FDA staff reviewers reported no major concerns about the accuracy and safety of Galleri, a blood test designed to detect more than 50 cancers. The FDA has no outstanding questions for its external advisers on Galleri’s analytical performance, study design or primary safety analyses, but asked them to assess whether the evidence supports describing it as an early-detection test. The company’s shares had fallen more than 20% since February after a pivotal three-year U.K. trial found routine screening did not significantly increase early detection or reduce late-stage diagnoses. Grail submitted its FDA application in January using data from a smaller U.S. trial, first-year U.K. trial results and a bridging analysis comparing an earlier version of the test. Galleri and Abbott Laboratories’ Cancerguard are already sold under Clinical Laboratory Improvement Amendments regulations, but neither has FDA approval. Approval would support broader distribution, physician guideline adoption and routine health insurance coverage. Galleri generated $136.8 million in U.S. revenue in 2025 and is intended to complement, rather than replace, established screening methods such as mammograms and colonoscopies.