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
A blood test screening for more than 50 cancers at once, before the FDA in September 2026.
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.
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.
Shares Clinical validation of a targeted methylation-based multi-cancer early detection test using an independent validation set, PATHFINDER 2, Performance of a multi-cancer early detection test in the randomized controlled NHS-Galleri trial, Galleri.
Shares PATHFINDER 2, Galleri, NHS-Galleri, Multi-cancer early detection (MCED).
Shares PATHFINDER 2, Performance of a multi-cancer early detection test in the randomized controlled NHS-Galleri trial, Galleri, NHS-Galleri.
Shares PATHFINDER 2, Galleri, NHS-Galleri, Multi-cancer early detection (MCED).
Shares PATHFINDER 2, Performance of a multi-cancer early detection test in the randomized controlled NHS-Galleri trial, Galleri, NHS-Galleri.
Shares PATHFINDER 2, Galleri, NHS-Galleri, Multi-cancer early detection (MCED).
Shares Performance of a multi-cancer early detection test in the randomized controlled NHS-Galleri trial, Galleri, NHS-Galleri, Multi-cancer early detection (MCED).
Shares PATHFINDER 2, Galleri, NHS-Galleri, Multi-cancer early detection (MCED).