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A high-profile clinical trial has dealt a significant blow to multi-cancer early detection (MCED) testing, with implications that extend directly into coverage policy and managed care decision-making. Grail recently announced that its Galleri blood test failed to achieve the primary endpoint of its large-scale NHS partnership study — a reduction in late-stage cancer diagnoses among screened participants.
The trial, reported by The New York Times, enrolled 142,000 healthy adults aged 50 to 77 in Britain and drew blood three times over approximately 3 years. One cohort underwent Galleri screening, which searches for cancer-derived DNA fragments across more than 50 cancer types. The other did not. The study was designed to demonstrate a 20% reduction in Stage 3 and Stage 4 cancer diagnoses among those screened. That threshold was not met.
For managed care organizations, the timing is consequential. Congress recently passed a spending package that authorized Medicare coverage of cancer-detection tests, creating a regulatory pathway for Galleri to eventually qualify for reimbursement. Grail has also filed for FDA approval. But the British trial results, described by Dr. Adewole Adamson of the University of Texas at Austin's Dell Medical School as a straightforward failure, may complicate both the regulatory and coverage calculus considerably.
The test has been commercially available in the United States since 2021 at $949 per test, sold under a regulatory exemption that bypasses FDA review. Grail has sold nearly 500,000 tests to date, with most costs borne out of pocket due to limited insurer coverage. Grail's stock fell roughly 50% following the announcement.
Biostatistician Dr. Ruth Etzioni of Fred Hutchinson Cancer Center noted that the study's failure raises unresolved questions about whether the endpoint criteria were appropriately designed. She and other researchers are calling for full data transparency before any definitive conclusions about coverage are drawn.
For payers weighing coverage decisions on MCED tests, the study underscores the gap between market enthusiasm and clinical evidence.
