{"entity":{"id":"galleri","kind":"drug","name":"Galleri","aka":[],"tldr":"A blood test screening for more than 50 cancers at once, before the FDA in September 2026.","summary":"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.\n\nIn 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.","status":"phase-3","asOf":"2026-09-04","links":[{"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":[],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":["mced","liquid-biopsy","methylation-profiling","cfdna-methylation-testing"],"targets":[],"drugs":[],"companies":["grail"],"institutions":[],"pathways":[],"terms":[],"trials":["nhs-galleri","pathfinder-2"],"people":[],"bottlenecks":[],"keyPapers":["paper-nhs-galleri-performance-nat-med-2026","paper-pathfinder-lancet-2023","paper-nhs-galleri-design-cancers-2022","paper-klein-ccga3-mced-validation-ann-oncol-2021"],"journals":[],"dependsOn":[],"notes":["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":{"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":"nhs-galleri","kind":"trial","name":"NHS-Galleri","route":"/trials/nhs-galleri/"},{"id":"pathfinder-2","kind":"trial","name":"PATHFINDER 2","route":"/trials/pathfinder-2/"},{"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-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-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/"}],"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/"}],"drug":[{"id":"cancerguard","kind":"drug","name":"Cancerguard","route":"/drugs/cancerguard/"}]}}