{"entity":{"id":"mced","kind":"technology","name":"Multi-cancer early detection (MCED)","aka":[],"tldr":"A single blood test intended to screen for dozens of cancers at once, including ones with no screening today.","summary":"Galleri (GRAIL) detects methylation patterns and predicts tissue of origin; PMA submitted to FDA in January 2026 with an advisory committee scheduled for 23 September 2026, based on PATHFINDER 2 and the 140,000-person NHS-Galleri trial. Exact Sciences' Cancerguard launched as an LDT; Guardant Shield adds multi-cancer results. Key open question: does earlier detection reduce mortality, and at what false-positive cost?\n\nThe first randomised evidence is in. NHS-Galleri's test-performance paper (Nature Medicine, 22 September 2026) reports positive results in 1.03, 0.80 and 0.90 percent of intervention-arm participants across three annual rounds, positive predictive values of 58.0, 50.4 and 45.8 percent, specificity of 99.50 to 99.60 percent, and episode sensitivity of 26.7 to 37.2 percent for all cancers and 47.6 to 63.4 percent for the 12 prespecified types; it states that the primary endpoint, a reduction in stage III/IV cancer incidence, was not met and is reported elsewhere.","status":"phase-3","asOf":"2026-09-04","links":[{"label":"DETECT-A: a blood test plus PET-CT found treatable cancers in 10,000 women with no symptoms (Science 2020)","url":"https://doi.org/10.1126/science.abb9601"},{"label":"NHS-Galleri: design of the largest randomised trial of a multi-cancer blood test (Cancers 2022)","url":"https://doi.org/10.3390/cancers14194818"},{"label":"NHS-Galleri: test performance across three annual rounds (Nature Medicine 2026)","url":"https://doi.org/10.1038/s41591-026-04652-8"}],"tags":[],"related":["ctdna-tests"],"cancers":["pancreatic"],"sections":["early-detection","diagnostics"],"technologies":[],"targets":[],"drugs":["galleri","shield"],"companies":["grail","exact-sciences","guardant-health","carrum-health","clearnote-health","elypta","exai-bio","numen","owlstone-medical","volitionrx"],"institutions":[],"pathways":[],"terms":["ppv","stage-shift"],"trials":["nhs-galleri","pathfinder-2"],"people":[],"bottlenecks":[],"keyPapers":["paper-nhs-galleri-performance-nat-med-2026","paper-nhs-galleri-design-cancers-2022","paper-pathfinder-lancet-2023","paper-cohen-cancerseek-multi-analyte-blood-test-science-2018","paper-detect-a-science-2020","paper-klein-ccga3-mced-validation-ann-oncol-2021","paper-fahrmann-ca19-9-lead-time-gastroenterology-2021"],"journals":[],"dependsOn":["liquid-biopsy"],"notes":["Pancreatic cancer: multi-cancer blood tests reach a median 70% sensitivity across eight cancer types including pancreas in case-control series (Cohen 2018) but only 16.8% at stage I in the methylation test's clinical validation (Klein 2021); in 10,006 women, blood testing plus PET-CT found 26 cancers with 1% false-positive imaging and 0.22% futile invasive procedures (Lennon 2020). CA 19-9 rises about two years before diagnosis and anchors most pancreatic panels (Fahrmann 2021)."],"principle":"Machine learning classifies cfDNA methylation, fragmentation, and protein biomarkers.","strengths":["Covers unscreened cancers (pancreatic, ovarian, liver)","One draw"],"limitations":["Low sensitivity for stage I","Mortality benefit unproven","Diagnostic odyssey after positive result"]},"route":"/technologies/mced/","neighbours":{"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":"kras-roadmap","kind":"roadmap","name":"KRAS roadmap: undruggable → G12C → pan-RAS","route":"/roadmaps/kras-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/"},{"id":"cure-paths","kind":"roadmap","name":"Paths to cures: interception, eradication, control","route":"/roadmaps/cure-paths/"}],"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"hcc","kind":"cancer","name":"Hepatocellular carcinoma","route":"/cancers/hcc/"},{"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/"}],"section":[{"id":"diagnostics","kind":"section","name":"Diagnostics & Biomarkers","route":"/fronts/diagnostics/"},{"id":"early-detection","kind":"section","name":"Early Detection & Screening","route":"/fronts/early-detection/"}],"drug":[{"id":"cancerguard","kind":"drug","name":"Cancerguard","route":"/drugs/cancerguard/"},{"id":"galleri","kind":"drug","name":"Galleri","route":"/drugs/galleri/"},{"id":"shield","kind":"drug","name":"Shield","route":"/drugs/shield/"}],"company":[{"id":"adela","kind":"company","name":"Adela","route":"/companies/adela/"},{"id":"carrum-health","kind":"company","name":"Carrum Health","route":"/companies/carrum-health/"},{"id":"clearnote-health","kind":"company","name":"ClearNote Health","route":"/companies/clearnote-health/"},{"id":"elypta","kind":"company","name":"Elypta","route":"/companies/elypta/"},{"id":"exact-sciences","kind":"company","name":"Exact Sciences (Abbott)","route":"/companies/exact-sciences/"},{"id":"exai-bio","kind":"company","name":"Exai Bio","route":"/companies/exai-bio/"},{"id":"freenome","kind":"company","name":"Freenome","route":"/companies/freenome/"},{"id":"grail","kind":"company","name":"GRAIL","route":"/companies/grail/"},{"id":"guardant-health","kind":"company","name":"Guardant Health","route":"/companies/guardant-health/"},{"id":"harbinger-health","kind":"company","name":"Harbinger Health","route":"/companies/harbinger-health/"},{"id":"lucence","kind":"company","name":"Lucence","route":"/companies/lucence/"},{"id":"numen","kind":"company","name":"Numen","route":"/companies/numen/"},{"id":"owlstone-medical","kind":"company","name":"Owlstone Medical","route":"/companies/owlstone-medical/"},{"id":"volitionrx","kind":"company","name":"VolitionRx","route":"/companies/volitionrx/"}],"term":[{"id":"ccga-study","kind":"term","name":"CCGA: the Circulating Cell-free Genome Atlas behind the Galleri methylation test","route":"/terms/ccga-study/"},{"id":"cfdna","kind":"term","name":"Cell-free DNA (cfDNA)","route":"/terms/cfdna/"},{"id":"ctdna","kind":"term","name":"Circulating tumour DNA (ctDNA)","route":"/terms/ctdna/"},{"id":"detect-a-study","kind":"term","name":"DETECT-A: a blood test plus PET-CT to screen 10,006 women with no symptoms","route":"/terms/detect-a-study/"},{"id":"early-detection-term","kind":"term","name":"Early detection","route":"/terms/early-detection-term/"},{"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":"ppv","kind":"term","name":"Positive predictive value (PPV)","route":"/terms/ppv/"},{"id":"screening","kind":"term","name":"Screening","route":"/terms/screening/"},{"id":"stage-shift","kind":"term","name":"Stage shift","route":"/terms/stage-shift/"},{"id":"tumour-informed-assay","kind":"term","name":"Tumour-informed versus tumour-naive ctDNA assays","route":"/terms/tumour-informed-assay/"}],"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":"ukctocs","kind":"trial","name":"UKCTOCS","route":"/trials/ukctocs/"},{"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-cohen-ctdna-protein-liquid-biopsy-pancreatic-pnas-2017","kind":"paper","name":"Combined circulating tumor DNA and protein biomarker-based liquid biopsy for the earlier detection of pancreatic cancers","route":"/key-papers/paper-cohen-ctdna-protein-liquid-biopsy-pancreatic-pnas-2017/"},{"id":"paper-detect-a-science-2020","kind":"paper","name":"DETECT-A: a blood test plus PET-CT found treatable cancers in 10,000 women with no symptoms","route":"/key-papers/paper-detect-a-science-2020/"},{"id":"paper-cohen-cancerseek-multi-analyte-blood-test-science-2018","kind":"paper","name":"Detection and localization of surgically resectable cancers with a multi-analyte blood test","route":"/key-papers/paper-cohen-cancerseek-multi-analyte-blood-test-science-2018/"},{"id":"paper-fahrmann-ca19-9-lead-time-gastroenterology-2021","kind":"paper","name":"Lead-Time Trajectory of CA19-9 as an Anchor Marker for Pancreatic Cancer Early Detection","route":"/key-papers/paper-fahrmann-ca19-9-lead-time-gastroenterology-2021/"},{"id":"paper-sharma-endpac-model-new-onset-diabetes-gastroenterology-2018","kind":"paper","name":"Model to Determine Risk of Pancreatic Cancer in Patients With New-Onset Diabetes","route":"/key-papers/paper-sharma-endpac-model-new-onset-diabetes-gastroenterology-2018/"},{"id":"paper-imperiale-multitarget-stool-dna-screening-nejm-2014","kind":"paper","name":"Multitarget stool DNA testing for colorectal-cancer screening","route":"/key-papers/paper-imperiale-multitarget-stool-dna-screening-nejm-2014/"},{"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-worthington-precede-early-detection-biomarkers-ijc-2026","kind":"paper","name":"Pancreatic cancer early detection biomarkers for high-risk individuals: insights from the PRECEDE 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tumour markers: proper use and misuse","route":"/technologies/serum-tumour-markers/"},{"id":"total-body-pet-screening","kind":"technology","name":"Total-body PET for screening and ultra-low-dose imaging","route":"/technologies/total-body-pet-screening/"}],"idea":[{"id":"idea-prev-mced-positive-resolution-pathway","kind":"idea","name":"A 28-day national pathway for people with a positive multi-cancer blood test","route":"/ideas/idea-prev-mced-positive-resolution-pathway/"},{"id":"idea-prev-emergency-department-cancer-test","kind":"idea","name":"A cancer blood test for older people arriving at A&E with unexplained symptoms","route":"/ideas/idea-prev-emergency-department-cancer-test/"},{"id":"idea-prev-mced-pretest-decision-aid","kind":"idea","name":"A mandatory decision aid before any multi-cancer blood test","route":"/ideas/idea-prev-mced-pretest-decision-aid/"},{"id":"idea-prev-lmic-five-cancer-methylation-test","kind":"idea","name":"A ten-dollar blood test for the five cancers that kill most people in poorer countries","route":"/ideas/idea-prev-lmic-five-cancer-methylation-test/"},{"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-bio2-survivor-plasma-biobank","kind":"idea","name":"Bank yearly blood from cancer survivors so future tests can be validated","route":"/ideas/idea-bio2-survivor-plasma-biobank/"},{"id":"idea-hcc-blood-surveillance","kind":"idea","name":"Blood-based HCC surveillance to replace six-monthly ultrasound","route":"/ideas/idea-hcc-blood-surveillance/"},{"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-prev-fragmentomics-first-tier","kind":"idea","name":"Cheap DNA fragment-pattern blood test as a first sieve before expensive cancer 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symptoms","route":"/ideas/idea-prev-mced-non-specific-symptom-triage/"},{"id":"idea-non-endoscopic-barretts-screening","kind":"idea","name":"Non-endoscopic screening for Barrett's oesophagus and early adenocarcinoma","route":"/ideas/idea-non-endoscopic-barretts-screening/"},{"id":"idea-prev-mced-change-control-plan","kind":"idea","name":"Pre-agreed update rules so an MCED test is not obsolete when its trial reads out","route":"/ideas/idea-prev-mced-change-control-plan/"},{"id":"idea-prev-mced-registry-randomised","kind":"idea","name":"Registry-based randomised MCED trial: a million people, no study visits","route":"/ideas/idea-prev-mced-registry-randomised/"}],"institution":[{"id":"arpa-h","kind":"institution","name":"Advanced Research Projects Agency for Health","route":"/institutions/arpa-h/"},{"id":"guys-st-thomas","kind":"institution","name":"Guy's and St Thomas' NHS Foundation Trust / King's Health Partners Cancer 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