{"entity":{"id":"galleri","kind":"drug","name":"Galleri","aka":[],"tldr":"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.","summary":"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.\n\nThe 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.","status":"phase-3","asOf":"2026-10-29","links":[{"label":"GRAIL: FDA advisory committee vote (23 September 2026)","url":"https://grail.com/press-releases/fda-advisory-committee-votes-in-favor-of-approval-of-grails-galleri-multi-cancer-early-detection-test/"},{"label":"NHS-Galleri primary endpoint (NEJM 2026)","url":"https://doi.org/10.1056/NEJMoa2505723"},{"label":"Public Law 119-75, section 6221 (Medicare coverage of multi-cancer tests)","url":"https://www.congress.gov/119/plaws/publ75/PLAW-119publ75.htm"},{"label":"GRAIL PMA announcement","url":"https://grail.com/press-releases/grail-submits-fda-premarket-approval-application-for-the-galleri-multi-cancer-early-detection-test/"},{"label":"NHS-Galleri test performance (Nature Medicine 2026)","url":"https://doi.org/10.1038/s41591-026-04652-8"}],"tags":["test","mced","evidence:no-benefit"],"related":["shield-mcd","cancerguard"],"cancers":["pancreatic"],"sections":[],"technologies":["mced","liquid-biopsy","methylation-profiling","cfdna-methylation-testing"],"targets":[],"drugs":[],"companies":["grail"],"institutions":[],"pathways":[],"terms":[],"trials":["nhs-galleri","pathfinder-2","pathfinder","ccga","strive-grail","reflection-galleri","reach-galleri-medicare","galleri-community-research-program","galleri-unintentional-weight-loss","inform-galleri","sentinel-galleri-veterans","discover-galleri-symptomatic","oc-lead"],"people":[],"bottlenecks":[],"keyPapers":["paper-nhs-galleri-primary-nejm-2026","paper-nhs-galleri-performance-nat-med-2026","paper-pathfinder-2-nat-med-2026","paper-pathfinder-lancet-2023","paper-nhs-galleri-design-cancers-2022","paper-klein-ccga3-mced-validation-ann-oncol-2021","paper-liu-ccga2-methylation-ann-oncol-2020","paper-symplify-lancet-oncol-2023","paper-galleri-real-world-nat-commun-2025"],"journals":[],"dependsOn":[],"notes":["Evidence grade no-benefit for the claim that it reduces late-stage diagnosis: the one adequately sized randomised trial, NHS-Galleri, found no reduction in stage III or IV cancer after three annual rounds (incidence rate ratio 1.03). The stage IV result (0.86, confidence interval reaching 1.00) is a secondary endpoint, and whether the test reduces cancer deaths has not been tested; follow-up continues to 2031.","What a result means: in NHS-Galleri about half of positive results were cancer and the test found about a third of the cancers diagnosed in a screening round, so a negative result does not replace bowel, breast, cervical or lung screening.","GRAIL's own statements, not peer-reviewed: that adding Galleri finds four to seven times more cancers than standard screening alone, and more than 90% cancer signal origin accuracy across more than 380,000 participants (releases of 23 September and 5 October 2026).","Pancreatic ductal adenocarcinoma: the CCGA3 validation read 16.8% sensitivity at stage I across all cancers at 99.5% specificity, which is the level at which a screening test would have to find pancreatic cancer to change its outcome; no pancreatic screening indication exists (Klein 2021)."],"modality":"Multi-cancer early detection blood test","mechanism":"Targeted cfDNA methylation sequencing with machine-learned cancer signal and tissue-of-origin classifier.","approvals":[],"mechanismSteps":["Blood is drawn and cell-free DNA extracted","Targeted methylation sequencing of ~100,000 regions","Machine-learning classifier detects a shared cancer methylation signal","A second classifier predicts the tissue of origin","A positive result directs diagnostic imaging and biopsy"],"toxicity":[],"access":[{"country":"US","listPrice":"$949 self-pay (GRAIL list price)","reimbursement":"Not covered by Medicare (pending FDA decision and the MCED Screening Coverage Act); some employer and Medicare Advantage programmes cover","source":"https://www.galleri.com/","asOf":"2026-09-06"},{"country":"UK","reimbursement":"Not available on the NHS; trial access via NHS-Galleri","asOf":"2026-09-06"}],"regulatoryEvents":[{"date":"2018-05","type":"designation","region":"US","note":"FDA Breakthrough Device designation","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2021-06","type":"filing","region":"US","note":"Launched as a laboratory-developed test","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2026-01-29","type":"filing","region":"US","note":"Final PMA module submitted","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2026-09-23","type":"advisory-committee","region":"US","note":"FDA Molecular and Clinical Genetics Panel meeting","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"}]},"route":"/drugs/galleri/","neighbours":{"drug":[{"id":"cancerguard","kind":"drug","name":"Cancerguard","route":"/drugs/cancerguard/"},{"id":"shield-mcd","kind":"drug","name":"Shield MCD (Shield Multi-Cancer Detection)","route":"/drugs/shield-mcd/"}],"cancer":[{"id":"ipmn-cystic-precursors","kind":"cancer","name":"Intraductal papillary mucinous neoplasm and other pancreatic cystic precursors","route":"/cancers/ipmn-cystic-precursors/"},{"id":"ovarian","kind":"cancer","name":"Ovarian cancer","route":"/cancers/ovarian/"},{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"}],"technology":[{"id":"cfdna-methylation-testing","kind":"technology","name":"Cell-free DNA methylation tests","route":"/technologies/cfdna-methylation-testing/"},{"id":"methylation-profiling","kind":"technology","name":"DNA methylation profiling","route":"/technologies/methylation-profiling/"},{"id":"liquid-biopsy","kind":"technology","name":"Liquid biopsy (ctDNA)","route":"/technologies/liquid-biopsy/"},{"id":"mced","kind":"technology","name":"Multi-cancer early detection (MCED)","route":"/technologies/mced/"}],"company":[{"id":"grail","kind":"company","name":"GRAIL","route":"/companies/grail/"}],"trial":[{"id":"ccga","kind":"trial","name":"CCGA (Circulating Cell-free Genome Atlas)","route":"/trials/ccga/"},{"id":"discover-galleri-symptomatic","kind":"trial","name":"DISCOVER (Galleri over time in people with symptoms)","route":"/trials/discover-galleri-symptomatic/"},{"id":"galleri-community-research-program","kind":"trial","name":"Galleri Community Research Program","route":"/trials/galleri-community-research-program/"},{"id":"galleri-unintentional-weight-loss","kind":"trial","name":"Galleri with weight tracking in unintentional weight loss (Case Comprehensive Cancer Center)","route":"/trials/galleri-unintentional-weight-loss/"},{"id":"inform-galleri","kind":"trial","name":"INFORM (Galleri in people with inherited cancer risk)","route":"/trials/inform-galleri/"},{"id":"nhs-galleri","kind":"trial","name":"NHS-Galleri","route":"/trials/nhs-galleri/"},{"id":"oc-lead","kind":"trial","name":"OC-LEAD (Galleri in BRCA carriers at risk of ovarian cancer)","route":"/trials/oc-lead/"},{"id":"pathfinder","kind":"trial","name":"PATHFINDER (first prospective study of the Galleri test)","route":"/trials/pathfinder/"},{"id":"pathfinder-2","kind":"trial","name":"PATHFINDER 2","route":"/trials/pathfinder-2/"},{"id":"reach-galleri-medicare","kind":"trial","name":"REACH (Galleri in the Medicare population)","route":"/trials/reach-galleri-medicare/"},{"id":"reflection-galleri","kind":"trial","name":"REFLECTION (Galleri real-world learning programme)","route":"/trials/reflection-galleri/"},{"id":"sentinel-galleri-veterans","kind":"trial","name":"Sentinel (Galleri in military veterans)","route":"/trials/sentinel-galleri-veterans/"},{"id":"strive-grail","kind":"trial","name":"STRIVE (GRAIL breast screening cohort)","route":"/trials/strive-grail/"},{"id":"vanguard-study","kind":"trial","name":"Vanguard Study (NCI Cancer Screening Research Network)","route":"/trials/vanguard-study/"}],"paper":[{"id":"paper-klein-ccga3-mced-validation-ann-oncol-2021","kind":"paper","name":"Clinical validation of a targeted methylation-based multi-cancer early detection test using an independent validation set","route":"/key-papers/paper-klein-ccga3-mced-validation-ann-oncol-2021/"},{"id":"paper-nhs-galleri-primary-nejm-2026","kind":"paper","name":"Effect of Screening with Multicancer Early-Detection Test on Late-Stage Cancer Diagnosis","route":"/key-papers/paper-nhs-galleri-primary-nejm-2026/"},{"id":"paper-jamshidi-ccga1-cfdna-approaches-cancer-cell-2022","kind":"paper","name":"Evaluation of cell-free DNA approaches for multi-cancer early detection","route":"/key-papers/paper-jamshidi-ccga1-cfdna-approaches-cancer-cell-2022/"},{"id":"paper-symplify-lancet-oncol-2023","kind":"paper","name":"Multi-cancer early detection test in symptomatic patients referred for cancer investigation in England and Wales (SYMPLIFY): a large-scale, observational cohort study","route":"/key-papers/paper-symplify-lancet-oncol-2023/"},{"id":"paper-nhs-galleri-design-cancers-2022","kind":"paper","name":"NHS-Galleri: design of the largest randomised trial of a multi-cancer blood test","route":"/key-papers/paper-nhs-galleri-design-cancers-2022/"},{"id":"paper-pathfinder-lancet-2023","kind":"paper","name":"PATHFINDER: the first prospective test of a multi-cancer blood test in people without symptoms","route":"/key-papers/paper-pathfinder-lancet-2023/"},{"id":"paper-pathfinder-2-nat-med-2026","kind":"paper","name":"Performance and safety of a multi-cancer early detection test: the PATHFINDER 2 study","route":"/key-papers/paper-pathfinder-2-nat-med-2026/"},{"id":"paper-nhs-galleri-performance-nat-med-2026","kind":"paper","name":"Performance of a multi-cancer early detection test in the randomized controlled NHS-Galleri trial","route":"/key-papers/paper-nhs-galleri-performance-nat-med-2026/"},{"id":"paper-galleri-real-world-nat-commun-2025","kind":"paper","name":"Real-world data and clinical experience from over 100,000 multi-cancer early detection tests","route":"/key-papers/paper-galleri-real-world-nat-commun-2025/"},{"id":"paper-liu-ccga2-methylation-ann-oncol-2020","kind":"paper","name":"Sensitive and specific multi-cancer detection and localization using methylation signatures in cell-free DNA","route":"/key-papers/paper-liu-ccga2-methylation-ann-oncol-2020/"},{"id":"paper-pathfinder-design-cancers-2021","kind":"paper","name":"The PATHFINDER Study: Assessment of the Implementation of an Investigational Multi-Cancer Early Detection Test into Clinical Practice","route":"/key-papers/paper-pathfinder-design-cancers-2021/"}],"idea":[{"id":"idea-moon-population-interception","kind":"idea","name":"A whole-population cancer interception programme: risk-stratify every adult, detect and intercept early","route":"/ideas/idea-moon-population-interception/"},{"id":"idea-mced-new-onset-diabetes","kind":"idea","name":"Blood-based pancreatic cancer detection in new-onset diabetes","route":"/ideas/idea-mced-new-onset-diabetes/"},{"id":"idea-mced-plus-fapi","kind":"idea","name":"FAPI PET as the workup for MCED positives","route":"/ideas/idea-mced-plus-fapi/"},{"id":"idea-prev-mced-stage-endpoint-surrogate","kind":"idea","name":"Let MCED trials read out on late-stage incidence, with mortality follow-up mandated","route":"/ideas/idea-prev-mced-stage-endpoint-surrogate/"},{"id":"idea-prev-interval-cancer-audit-blood-tests","kind":"idea","name":"Mandatory interval-cancer audit for every blood-based screening test","route":"/ideas/idea-prev-interval-cancer-audit-blood-tests/"},{"id":"idea-prev-mced-non-specific-symptom-triage","kind":"idea","name":"Multi-cancer blood test as the first step for patients with non-specific symptoms","route":"/ideas/idea-prev-mced-non-specific-symptom-triage/"}],"term":[{"id":"ccga-study","kind":"term","name":"CCGA: the Circulating Cell-free Genome Atlas behind the Galleri methylation test","route":"/terms/ccga-study/"},{"id":"fda-ldt-rule","kind":"term","name":"FDA laboratory-developed test (LDT) rule","route":"/terms/fda-ldt-rule/"},{"id":"new-onset-diabetes-pancreatic-cancer","kind":"term","name":"New-onset diabetes as a signal of pancreatic cancer (and the ENDPAC score)","route":"/terms/new-onset-diabetes-pancreatic-cancer/"},{"id":"screening","kind":"term","name":"Screening","route":"/terms/screening/"},{"id":"tumour-informed-assay","kind":"term","name":"Tumour-informed versus tumour-naive ctDNA assays","route":"/terms/tumour-informed-assay/"}],"roadmap":[{"id":"ctdna-tests","kind":"roadmap","name":"ctDNA tests roadmap: from a curiosity in plasma to blood tests that decide treatment","route":"/roadmaps/ctdna-tests/"},{"id":"early-detection-roadmap","kind":"roadmap","name":"Early detection roadmap: organ screening → blood tests for many cancers","route":"/roadmaps/early-detection-roadmap/"},{"id":"pancreatic-roadmap","kind":"roadmap","name":"Pancreatic cancer roadmap: from Whipple's operation to gemcitabine, FOLFIRINOX, adjuvant chemotherapy, PARP inhibition, KRAS inhibition, vaccines and the surveillance question","route":"/roadmaps/pancreatic-roadmap/"}],"person":[{"id":"deb-schrag","kind":"person","name":"Deborah Schrag","route":"/people/deb-schrag/"},{"id":"eric-klein","kind":"person","name":"Eric A. Klein","route":"/people/eric-klein/"},{"id":"peter-sasieni","kind":"person","name":"Peter Sasieni","route":"/people/peter-sasieni/"}],"bottleneck":[{"id":"b-early-detection","kind":"bottleneck","name":"The hardest cancers are found late","route":"/bottlenecks/b-early-detection/"}],"institution":[{"id":"guys-st-thomas","kind":"institution","name":"Guy's and St Thomas' NHS Foundation Trust / King's Health Partners Cancer Centre","route":"/institutions/guys-st-thomas/"}]}}