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GRAIL's blood test that looks for a signal from more than 50 cancers at once; an FDA advisory panel voted in its favour in September 2026, but in the NHS-Galleri randomised trial three yearly tests did not reduce the number of cancers found at a late stage.
Galleri is GRAIL's multi-cancer early detection test: targeted methylation sequencing of cell-free DNA, read by a machine-learned classifier that reports whether a cancer signal is present and, if so, its predicted cancer signal origin. GRAIL markets it for more than 50 cancer types. It has been sold in the United States from GRAIL's CLIA-certified laboratory since 2021; GRAIL's cost page states it has not been cleared or approved by the FDA and gives a list price of $949. GRAIL submitted its premarket approval application on 29 January 2026, and on 23 September 2026 the FDA's Molecular and Clinical Genetics Devices Panel voted seven to two, with one abstention, that its benefits outweigh its risks for adults aged 50 and older (safety unanimous; effectiveness six to four), according to GRAIL. No FDA decision had been announced by 29 October 2026. Medicare coverage of FDA-authorised multi-cancer tests was enacted in February 2026 (Public Law 119-75, section 6221) for tests furnished from 1 January 2029.
The evidence. In the third CCGA case-control substudy (Klein 2021) specificity was 99.5% and sensitivity 16.8% at stage I, 40.4% at stage II, 77.0% at stage III and 90.1% at stage IV. In PATHFINDER 2 (Nature Medicine 2026; 35,878 enrolled, 32,007 analysable), single-arm, positive predictive value was 60.3%, specificity 99.64%, episode sensitivity 39.3% for all cancers and 69.8% for 12 prespecified cancers, and 185 people were screened to find one cancer. In the randomised NHS-Galleri trial (142,250 people aged 50 to 77 in England), the test-performance paper (Nature Medicine 2026) reports positive predictive values of 58.0, 50.4 and 45.8% across three rounds and episode sensitivity of 26.7 to 37.2% for all cancers, and the primary-endpoint paper (Sasieni, NEJM 2026) reports that the incidence of stage III or IV cancer did not differ between the groups (incidence rate ratio 1.03; 95% CI 0.92 to 1.14), with a stage IV incidence rate ratio of 0.86 (0.74 to 1.00) as a key secondary endpoint. Cancer deaths have not yet been reported. In people referred with symptoms (SYMPLIFY, Lancet Oncology 2023) it detected 24.2% of stage I cancers.
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 | - |
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This is the first randomised answer to whether a multi-cancer blood test changes outcomes, and for its main question the answer was no: adding the test to NHS care for three years did not lower the number of cancers diagnosed at stage III or IV. The stage IV result is a secondary finding with a confidence interval that touches no effect, and deaths have not yet been reported, so the trial continues to follow participants.
These are the numbers GRAIL's US application rests on. Six in ten positive results were cancer and the predicted organ was usually right, but six in ten cancers diagnosed in the year were not flagged, and the study had no control group, so it cannot say whether testing changes outcomes.
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.
Outcomes are known for fewer than half of the positives, so the share of positives that were cancer in this group cannot be read as the test's positive predictive value, and cancers missed by the test are not counted at all.
In people who already have symptoms the test is more often right when positive, because cancer is commoner, but it still misses most stage I cancers, so a negative result cannot cancel an urgent referral.
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.
Whether a cancer is found depends mostly on how much tumour DNA it sheds into the blood, which is why small early cancers are often missed by every approach.
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.
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.
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Shares DNA methylation profiling, Multi-cancer early detection (MCED), Liquid biopsy (ctDNA) and the tags test, mced.
Shares DNA methylation profiling, Multi-cancer early detection (MCED), Liquid biopsy (ctDNA) and the tags test, mced.
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