Galleri
A blood test screening for more than 50 cancers at once, before the FDA in September 2026.
Galleri is GRAIL's methylation-based MCED. Available as an LDT since 2021 (~$949). PATHFINDER 2 (25,000+ participants) and NHS-Galleri (140,000 randomised) underpin the PMA submitted January 2026; FDA advisory committee 23 September 2026. Cancer signal detected in ~1% of screened adults with PPV ~40-60% in PATHFINDER 2; sensitivity for stage I disease is low.
1.Blood is drawn and cell-free DNA extracted
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| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Not covered by Medicare (pending FDA decision and the MCED Screening Coverage Act); some employer and Medicare Advantage programmes cover | $949 self-pay (GRAIL list price) | — |
| United Kingdom | Not available on the NHS; trial access via NHS-Galleri | not disclosed | — |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
A multi-cancer blood test can be run in ordinary clinics, and most positive results can be resolved with imaging. But six in ten positives are false alarms that take months to resolve, and the test misses most cancers. Whether it reduces late-stage cancer or deaths is unknown; that requires randomised trials.
NHS-Galleri is the trial that will decide whether a blood test for many cancers at once should be offered by a health system. Its endpoint is a reduction in late-stage cancer rather than deaths, so even a positive result leaves the mortality question to be settled by longer follow-up.
Latest papers
topQuery for this drug: (TITLE:"Galleri" OR ABSTRACT:"Galleri") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Galleri, not a curated reading list.