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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.
In the NHS-Galleri randomised trial, the peer-reviewed test-performance paper (Nature Medicine, 22 September 2026) reports that about 1 in 100 intervention-arm participants had a positive result in each of three annual rounds (1.03, 0.80 and 0.90 percent), that 58.0, 50.4 and 45.8 percent of those positives were cancer, that specificity was 99.50 to 99.60 percent, and that the test found 26.7 to 37.2 percent of all cancers and 47.6 to 63.4 percent of the 12 prespecified types in a screening round; the same paper states the trial's primary endpoint, a reduction in stage III/IV cancer incidence, was not met.
Targeted cfDNA methylation sequencing with machine-learned cancer signal and tissue-of-origin classifier.
1.Blood is drawn and cell-free DNA extracted
Follows the 23 September 2026 advisory committee. PMA decisions typically come months after the panel; no date has been announced. Source
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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.
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For someone offered the test, these are the numbers that describe what a result means in an NHS population: about 1 in 100 tests came back positive each year, between 46 and 58 in 100 positives were cancer, and a negative result left about 1 in 100 with an undetected cancer within the year. The test found between a quarter and a third of all cancers diagnosed in a screening round, and about half to two thirds of the 12 cancer types it was designed to find. Whether finding them this way reduces late-stage diagnoses is the primary question, and this paper says only that the answer was no; the primary-endpoint paper had not appeared on Europe PMC by 23 September 2026.
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.
Methylation-based screening is real but weakest exactly where pancreatic cancer needs it, at stage I, which is why high-risk surveillance rather than population screening carries the field here.
Query 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.
Shares Multi-cancer blood test as the first step for patients with non-specific symptoms, Cancerguard, Vanguard Study (NCI Cancer Screening Research Network), CCGA: the Circulating Cell-free Genome Atlas behind the Galleri methylation test.
Shares Vanguard Study (NCI Cancer Screening Research Network), CCGA: the Circulating Cell-free Genome Atlas behind the Galleri methylation test, Let MCED trials read out on late-stage incidence, with mortality follow-up mandated, New-onset diabetes as a signal of pancreatic cancer (and the ENDPAC score).
Shares Cancerguard, Mandatory interval-cancer audit for every blood-based screening test, Early detection roadmap: organ screening → blood tests for many cancers, Screening.
Shares GRAIL, PATHFINDER 2, NHS-Galleri, Multi-cancer early detection (MCED).
Shares FAPI PET as the workup for MCED positives, PATHFINDER: the first prospective test of a multi-cancer blood test in people without symptoms, Multi-cancer early detection (MCED), ctDNA tests roadmap: from a curiosity in plasma to blood tests that decide treatment.
Shares Vanguard Study (NCI Cancer Screening Research Network), NHS-Galleri: design of the largest randomised trial of a multi-cancer blood test, Multi-cancer early detection (MCED), The hardest cancers are found late.
Shares New-onset diabetes as a signal of pancreatic cancer (and the ENDPAC score), Intraductal papillary mucinous neoplasm and other pancreatic cystic precursors, The hardest cancers are found late, Liquid biopsy (ctDNA).
Shares Cancerguard, Early detection roadmap: organ screening → blood tests for many cancers, Multi-cancer early detection (MCED), ctDNA tests roadmap: from a curiosity in plasma to blood tests that decide treatment.