GRAIL developed Galleri, the multi-cancer blood test awaiting an FDA decision after a September 2026 advisory committee.
GRAIL, based in Menlo Park and listed as GRAL, developed Galleri, the multi-cancer blood test awaiting an FDA decision after an advisory committee in September 2026. The company submitted its premarket approval application in January 2026, the NHS-Galleri trial in England and the PATHFINDER 2 study are its main evidence, and it was spun out of Illumina in 2024. OnCo links it to multi-cancer early detection, to the bottleneck that the hardest cancers are found late, to Guy's and St Thomas' and the Chinese University of Hong Kong, and to ideas on using a multi-cancer test as the first step for patients with non-specific symptoms and on pre-agreed update rules so a test is not obsolete when its trial reads out. Whether detecting more cancers earlier lowers deaths from them is the open question no MCED trial has yet answered. Galleri has its own page.
Follows the 23 September 2026 advisory committee. PMA decisions typically come months after the panel; no date has been announced. Source
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.
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.
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.
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.
Set beside the result (35 cancers among 92 positives, positive predictive value 38%), it shows the test found fewer cancers than its makers had modelled.
Shares Multi-cancer early detection test in symptomatic patients referred for cancer investigation in England and Wales (SYMPLIFY): a large-scale, observational cohort study, Evaluation of cell-free DNA approaches for multi-cancer early detection, Sensitive and specific multi-cancer detection and localization using methylation signatures in cell-free DNA, Performance and safety of a multi-cancer early detection test: the PATHFINDER 2 study.
Shares The PATHFINDER Study: Assessment of the Implementation of an Investigational Multi-Cancer Early Detection Test into Clinical Practice, PATHFINDER (first prospective study of the Galleri test), Performance and safety of a multi-cancer early detection test: the PATHFINDER 2 study, PATHFINDER 2.
Shares Real-world data and clinical experience from over 100,000 multi-cancer early detection tests, Multi-cancer blood test as the first step for patients with non-specific symptoms, Multi-cancer early detection test in symptomatic patients referred for cancer investigation in England and Wales (SYMPLIFY): a large-scale, observational cohort study, The PATHFINDER Study: Assessment of the Implementation of an Investigational Multi-Cancer Early Detection Test into Clinical Practice.
Shares Effect of Screening with Multicancer Early-Detection Test on Late-Stage Cancer Diagnosis, PATHFINDER 2, Performance of a multi-cancer early detection test in the randomized controlled NHS-Galleri trial, NHS-Galleri.
Shares Evaluation of cell-free DNA approaches for multi-cancer early detection, Sensitive and specific multi-cancer detection and localization using methylation signatures in cell-free DNA, PATHFINDER 2, NHS-Galleri.
Shares Effect of Screening with Multicancer Early-Detection Test on Late-Stage Cancer Diagnosis, Performance of a multi-cancer early detection test in the randomized controlled NHS-Galleri trial, NHS-Galleri, Galleri.
Shares PATHFINDER 2, NHS-Galleri, Galleri, ctDNA tests roadmap: from a curiosity in plasma to blood tests that decide treatment.
Shares CCGA (Circulating Cell-free Genome Atlas), Clinical validation of a targeted methylation-based multi-cancer early detection test using an independent validation set, Galleri, Multi-cancer early detection (MCED).
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