{"entity":{"id":"mced","kind":"technology","name":"Multi-cancer early detection (MCED)","aka":["Multi-cancer detection (MCD)","Multi-cancer early detection blood test","Pan-cancer screening blood test"],"tldr":"A single blood (or urine) test meant to look for many cancers at once, including ones with no screening today. About 27 such tests are sold or in study worldwide; none has yet been shown in a randomised trial to reduce cancer deaths, and the one randomised result so far did not reduce late-stage diagnoses.","summary":"What exists. OnCo's census of 29 October 2026 found 27 multi-cancer tests that are sold, in clinical validation or published, in the United States, Europe and Asia, reading cell-free DNA methylation (Galleri, Shield MCD, Avantect, OverC, PanSeer, CancerFind), DNA fragment patterns (SPOT-MAS, SeekInCare, ai-CANCERCH), proteins (OneTest, OncoSeek, Novelna), methylation with proteins (Cancerguard), sugar molecules in urine and blood (Elypta), circulating tumour cells (Trucheck), platelet RNA (thromboSeq), infrared spectra (Dxcover), nucleosomes (Nu.Q), amino acids (AminoIndex) and even worms' sense of smell (N-NOSE). The tests sold to the public are laboratory-developed tests or CE- or UKCA-marked products; no multi-cancer screening test had been approved by the FDA, China's NMPA or Japan's PMDA by 29 October 2026, and a CE mark is a conformity mark, not evidence that screening helps. GRAIL's Galleri is furthest: a premarket approval application filed on 29 January 2026 and an FDA advisory panel vote of seven to two in favour on 23 September 2026, with no FDA decision yet. Several others hold FDA Breakthrough Device designations (Shield MCD, OverC, SPOT-MAS 10), which speed review but are not approvals. US Medicare coverage of FDA-authorised multi-cancer tests begins on 1 January 2029 under Public Law 119-75.\n\nWhat the evidence shows. Almost all published performance comes from case-control studies of people already diagnosed, which overstate how a test performs in screening. Where tests have been run prospectively in people without symptoms, about one in a hundred to two hundred tests is positive and 40 to 60 in 100 positives are cancer (PATHFINDER 2: 60.3%; NHS-Galleri: 45.8 to 58.0%; K-DETEK with SPOT-MAS: 39.5%), and Galleri found about a quarter to two fifths of the cancers diagnosed within a year (26.7 to 37.2% per round in NHS-Galleri, 39.3% in PATHFINDER 2). Sensitivity for stage I cancer, where finding cancer early matters most, is about one in six for Galleri (16.8% in CCGA) and Cancerguard's development classifier (15.4%).\n\nWhat it has not shown. The first randomised result is in: NHS-Galleri, 142,250 people in England, found no reduction in stage III or IV cancers after three yearly rounds (incidence rate ratio 1.03; 95% CI 0.92 to 1.14; Sasieni, NEJM 2026), with a secondary stage IV ratio of 0.86 (0.74 to 1.00). No multi-cancer test has been shown in a randomised trial to reduce cancer deaths. The NCI's randomised Vanguard study (Shield MCD and Avantect against usual care, 24,000 people) is testing how a definitive trial could be run. Until then a negative result does not replace bowel, breast, cervical or lung screening, and a positive result is the start of tests, not a diagnosis.","status":"phase-3","asOf":"2026-10-29","links":[{"label":"NHS-Galleri primary endpoint: no reduction in stage III or IV cancer (NEJM 2026)","url":"https://doi.org/10.1056/NEJMoa2505723"},{"label":"PATHFINDER 2 (Nature Medicine 2026)","url":"https://doi.org/10.1038/s41591-026-04618-w"},{"label":"NCI selects two assays for the Vanguard Study","url":"https://prevention.cancer.gov/news-and-events/news/nci-selects-two-assays-vanguard-study-multi-cancer-detection-tests"},{"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":["precision","evidence:insufficient"],"related":["ctdna-tests"],"cancers":["pancreatic"],"sections":["early-detection","diagnostics"],"technologies":[],"targets":[],"drugs":["galleri","cancerguard","shield-mcd","avantect-mcd","harbinger-resolve","cancerseek","onetest","novelna-protein-test","adela-mced","gagome-mced-test","carcimun-test","dxcover-cancer-liquid-biopsy","pantum-detect","nu-q-cancer","thromboseq","epipangi-dx","overc-mcdbt","panseer","oncoseek","seekincare","spot-mas","trucheck-intelli","anpac-cda","n-nose","cancerfind","ai-cancerch","aminoindex-cancer-screening","shield"],"companies":["grail","exact-sciences","guardant-health","clearnote-health","harbinger-health","adela","elypta","exai-bio","numen","owlstone-medical","volitionrx","carrum-health","delfi-diagnostics","freenome","burning-rock","singlera","seekin","gene-solutions","datar-cancer-genetics","hirotsu-bio-science","imbdx","gc-genome","mirxes","novelna","dxcover","zyagnum","2020-biolabs"],"institutions":[],"pathways":[],"terms":["ppv","stage-shift","screening","cfdna"],"trials":["nhs-galleri","pathfinder-2","vanguard-study","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","ascend-cancerseek","falcon-registry","regenerate-pancreatic-genetics-mced","alliance-a212102-mced-reference-set","mayo-mcd-cohort","clearnote-multi-cancer-epigenomics","inova-burn-pit-screening","inova-firefighter-screening","mdacc-mced-decision-aid","dartmouth-mced-information-trial","predict-overc","thunder-overc","prevent-overc","promise-cams","prescient-cams","perceive-1","perceive-2","fusion-singlera","inspire-singlera","lev87a","lev93a","vincere-firefighters-mced","core-hh","procares","camperr","cadence-mirxes","pan-owlstone","k-detek","k-accelerate","profound-mced","prosight-mced","profuture-mced","nqmd-cs","jinling-cohort","wuhan-pan-cancer-methylation-pcr","beijing-metabolomics-multi-cancer","decipher-gastro","yonsei-mced-wgs","yonsei-mced-wgs-2","yonsei-multi-cancer-mrd","methylscape-co","exopert-emerald","pantum-detect-max-healthcare","pantumpet","xijing-cfdna-seven-cancers","exai-oncrna-prospective"],"people":[],"bottlenecks":[],"keyPapers":["paper-nhs-galleri-primary-nejm-2026","paper-nhs-galleri-performance-nat-med-2026","paper-pathfinder-2-nat-med-2026","paper-nhs-galleri-design-cancers-2022","paper-pathfinder-lancet-2023","paper-klein-ccga3-mced-validation-ann-oncol-2021","paper-liu-ccga2-methylation-ann-oncol-2020","paper-symplify-lancet-oncol-2023","paper-detect-a-science-2020","paper-cohen-cancerseek-multi-analyte-blood-test-science-2018","paper-cancerguard-mp-classifier-cebp-2026","paper-cristiano-delfi-fragmentomes-nature-2019","paper-gao-thunder-ann-oncol-2023","paper-spot-mas-k-detek-bmc-med-2025","paper-bao-fragmentomics-nat-med-2025","paper-bratulic-gagome-pnas-2022","paper-thromboseq-cancer-cell-2022","paper-hinestrosa-ev-protein-commun-med-2022","paper-fahrmann-ca19-9-lead-time-gastroenterology-2021"],"journals":[],"dependsOn":["liquid-biopsy"],"notes":["Evidence grade insufficient for the class claim that multi-cancer blood tests reduce cancer deaths: no randomised trial has reported mortality, and NHS-Galleri, the only randomised trial to report, did not meet its late-stage endpoint. Individual tests are graded on their own records; Galleri is graded no-benefit for late-stage diagnosis on the NHS-Galleri result.","Single-cancer blood tests are context, not multi-cancer tests: Shield and SimpleScreen for colorectal cancer, FirstLook Lung, HelioLiver, the EpiCheck tests and Mercy BioAnalytics' ovarian test.","Not covered by this census for lack of search capacity on 29 October 2026: tests from Haplox, AnchorDx, Berry Oncology and BGI, Hong Kong and Taiwan developers, Indian tests other than Trucheck, and ChiCTR registrations.","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 cell-free DNA methylation, fragmentation, mutations, proteins or other blood and urine signals, usually with a predicted organ of origin.","strengths":["Covers cancers with no screening test (pancreatic, ovarian, liver)","One blood draw","Prospective positive predictive values of about 40 to 60% in people without symptoms"],"limitations":["Low sensitivity for stage I cancer","No reduction in late-stage cancer in the only randomised trial so far; mortality benefit untested","Diagnostic work-up after a false positive","Case-control figures overstate screening performance"]},"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 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(AICS)","route":"/drugs/aminoindex-cancer-screening/"},{"id":"avantect-mcd","kind":"drug","name":"Avantect Multi-Cancer Detection Test","route":"/drugs/avantect-mcd/"},{"id":"anpac-cda","kind":"drug","name":"Cancer Differentiation Analysis (CDA)","route":"/drugs/anpac-cda/"},{"id":"cancerfind","kind":"drug","name":"CancerFind","route":"/drugs/cancerfind/"},{"id":"cancerguard","kind":"drug","name":"Cancerguard","route":"/drugs/cancerguard/"},{"id":"cancerseek","kind":"drug","name":"CancerSEEK","route":"/drugs/cancerseek/"},{"id":"carcimun-test","kind":"drug","name":"Carcimun test","route":"/drugs/carcimun-test/"},{"id":"dxcover-cancer-liquid-biopsy","kind":"drug","name":"Dxcover Cancer Liquid Biopsy","route":"/drugs/dxcover-cancer-liquid-biopsy/"},{"id":"gagome-mced-test","kind":"drug","name":"Elypta GAGome multi-cancer test","route":"/drugs/gagome-mced-test/"},{"id":"epipangi-dx","kind":"drug","name":"EpiPanGI Dx","route":"/drugs/epipangi-dx/"},{"id":"galleri","kind":"drug","name":"Galleri","route":"/drugs/galleri/"},{"id":"n-nose","kind":"drug","name":"N-NOSE","route":"/drugs/n-nose/"},{"id":"novelna-protein-test","kind":"drug","name":"Novelna sex-specific protein test","route":"/drugs/novelna-protein-test/"},{"id":"nu-q-cancer","kind":"drug","name":"Nu.Q Cancer","route":"/drugs/nu-q-cancer/"},{"id":"oncoseek","kind":"drug","name":"OncoSeek","route":"/drugs/oncoseek/"},{"id":"onetest","kind":"drug","name":"OneTest for Cancer","route":"/drugs/onetest/"},{"id":"overc-mcdbt","kind":"drug","name":"OverC Multi-Cancer Detection Blood Test","route":"/drugs/overc-mcdbt/"},{"id":"panseer","kind":"drug","name":"PanSeer","route":"/drugs/panseer/"},{"id":"pantum-detect","kind":"drug","name":"PanTum Detect","route":"/drugs/pantum-detect/"},{"id":"harbinger-resolve","kind":"drug","name":"RESOLVE (Harbinger 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Solutions","route":"/companies/gene-solutions/"},{"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":"hirotsu-bio-science","kind":"company","name":"Hirotsu Bio Science","route":"/companies/hirotsu-bio-science/"},{"id":"imbdx","kind":"company","name":"IMBdx","route":"/companies/imbdx/"},{"id":"lucence","kind":"company","name":"Lucence","route":"/companies/lucence/"},{"id":"mirxes","kind":"company","name":"Mirxes","route":"/companies/mirxes/"},{"id":"novelna","kind":"company","name":"Novelna","route":"/companies/novelna/"},{"id":"numen","kind":"company","name":"Numen","route":"/companies/numen/"},{"id":"owlstone-medical","kind":"company","name":"Owlstone 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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":"alliance-a212102-mced-reference-set","kind":"trial","name":"Alliance A212102: blinded reference set for multi-cancer detection 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cancers)","route":"/trials/pan-owlstone/"},{"id":"wuhan-pan-cancer-methylation-pcr","kind":"trial","name":"Pan-cancer plasma DNA methylation PCR test (Wuhan Ammunition Life-tech)","route":"/trials/wuhan-pan-cancer-methylation-pcr/"},{"id":"pantum-detect-max-healthcare","kind":"trial","name":"PanTum Detect diagnostic accuracy study (Max Healthcare, India)","route":"/trials/pantum-detect-max-healthcare/"},{"id":"pantumpet","kind":"trial","name":"PanTumPET (PanTum Detect against PET-CT, Comenius University)","route":"/trials/pantumpet/"},{"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":"perceive-1","kind":"trial","name":"PERCEIVE-I (multi-omic blood test for gynaecological cancers)","route":"/trials/perceive-1/"},{"id":"perceive-2","kind":"trial","name":"PERCEIVE-II (extended validation for gynaecological cancers)","route":"/trials/perceive-2/"},{"id":"beijing-metabolomics-multi-cancer","kind":"trial","name":"Plasma metabolite markers for 13 cancers (Beijing Friendship Hospital)","route":"/trials/beijing-metabolomics-multi-cancer/"},{"id":"predict-overc","kind":"trial","name":"PREDICT (Burning Rock pan-cancer early detection project)","route":"/trials/predict-overc/"},{"id":"prescient-cams","kind":"trial","name":"PRESCIENT (pan-cancer early-stage detection, Chinese Academy of Medical Sciences)","route":"/trials/prescient-cams/"},{"id":"prevent-overc","kind":"trial","name":"PREVENT (OverC in people without symptoms)","route":"/trials/prevent-overc/"},{"id":"procares","kind":"trial","name":"PROCARES (Harbinger Health diagnostic aid in people with suspected cancer)","route":"/trials/procares/"},{"id":"profound-mced","kind":"trial","name":"PROFOUND (Weihe multi-omic multi-cancer case-control study)","route":"/trials/profound-mced/"},{"id":"profuture-mced","kind":"trial","name":"PROFUTURE 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