{"entity":{"id":"cancerguard","kind":"drug","name":"Cancerguard","aka":[],"tldr":"Exact Sciences' multi-cancer blood test, sold since 2025 as a lab test that has not been through FDA approval; it says whether a cancer signal is present but not where, so a positive result leads to scans.","summary":"Cancerguard launched on 10 September 2025 as a prescription-only laboratory-developed test for adults aged 50 to 84 without a cancer diagnosis in the previous three years, at a launch price of $689 stated by Exact Sciences. Exact describes it as reading ctDNA methylation and proteins as biomarker classes and says it can help detect over 50 cancer types and subtypes; its site states that it is not FDA cleared or approved. It does not predict where a cancer is, so a positive result is followed by an imaging-guided work-up. Exact Sciences has been wholly owned by Abbott since March 2026.\n\nThe evidence. Exact's own development figures (company statements, not peer-reviewed for the launched test) are 68% sensitivity across six deadly cancers, 64% excluding breast and prostate, at 97.4% specificity. The only peer-reviewed stage-by-stage figures (Gainullin et al., Cancer Epidemiology, Biomarkers & Prevention 2026) are for the development methylation and protein classifier in 6,352 case-control samples: 50.9% overall sensitivity at 98.5% specificity, with 15.4% at stage I, 38.0% at stage II, 67.8% at stage III and 85.5% at stage IV. The approach descends from CancerSEEK and the DETECT-A study with Johns Hopkins and Geisinger, the first prospective interventional study of a multi-cancer blood test. The Falcon Registry (NCT06589310) is following up to 25,000 people tested in practice. No randomised trial has yet shown that a multi-cancer blood test reduces deaths.","status":"emerging","asOf":"2026-10-29","links":[{"label":"Exact Sciences: Cancerguard launch (10 September 2025)","url":"https://www.exactsciences.com/newsroom/press-releases/exact-sciences-launches-cancerguard-first-of-its-kind-multi-cancer-early-detection-blood-test"},{"label":"Gainullin et al., CEBP 2026","url":"https://doi.org/10.1158/1055-9965.EPI-26-0541"},{"label":"ClinicalTrials.gov NCT06589310 (Falcon Registry)","url":"https://clinicaltrials.gov/study/NCT06589310"},{"label":"Exact Sciences: Cancerguard","url":"https://www.exactsciences.com/"}],"tags":["mced","evidence:insufficient"],"related":["galleri","shield","cancerseek"],"cancers":[],"sections":[],"technologies":["mced","liquid-biopsy","methylation-profiling","proteomics"],"targets":[],"drugs":[],"companies":["exact-sciences"],"institutions":[],"pathways":[],"terms":["ppv","screening","fda-ldt-rule"],"trials":["falcon-registry","ascend-cancerseek"],"people":[],"bottlenecks":[],"keyPapers":["paper-cancerguard-mp-classifier-cebp-2026","paper-detect-a-science-2020","paper-cohen-cancerseek-multi-analyte-blood-test-science-2018"],"journals":[],"dependsOn":[],"notes":["Evidence grade insufficient for the claim that it reduces late-stage diagnosis or cancer deaths: no randomised trial of it has reported either outcome; published performance is case-control, and the one randomised trial of any multi-cancer test, NHS-Galleri, did not show fewer stage III or IV cancers.","What a result means: a positive signal starts a diagnostic work-up with scans; most people with a positive result will not turn out to have cancer, and a negative result does not replace mammograms, colonoscopy or other proven screening.","The 15.4% stage I figure is from the development classifier at 98.5% specificity, not the launched test's 97.4% specificity setting."],"brand":"Cancerguard","modality":"Multi-cancer early detection blood test (laboratory-developed)","mechanism":"Plasma assay combining cell-free DNA methylation and protein biomarkers across multiple classes, reporting a cancer signal without a tissue-of-origin call, followed by imaging work-up.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[{"country":"US","listPrice":"US$689 (launch price stated by Exact Sciences, September 2025)","source":"https://www.exactsciences.com/newsroom/press-releases/exact-sciences-launches-cancerguard-first-of-its-kind-multi-cancer-early-detection-blood-test","asOf":"2025-09-10"}],"regulatoryEvents":[]},"route":"/drugs/cancerguard/","neighbours":{"drug":[{"id":"cancerseek","kind":"drug","name":"CancerSEEK","route":"/drugs/cancerseek/"},{"id":"galleri","kind":"drug","name":"Galleri","route":"/drugs/galleri/"},{"id":"shield","kind":"drug","name":"Shield","route":"/drugs/shield/"}],"technology":[{"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/"},{"id":"proteomics","kind":"technology","name":"Proteomics & phosphoproteomics","route":"/technologies/proteomics/"}],"company":[{"id":"exact-sciences","kind":"company","name":"Exact Sciences (Abbott)","route":"/companies/exact-sciences/"}],"term":[{"id":"fda-ldt-rule","kind":"term","name":"FDA laboratory-developed test (LDT) rule","route":"/terms/fda-ldt-rule/"},{"id":"ppv","kind":"term","name":"Positive predictive value (PPV)","route":"/terms/ppv/"},{"id":"screening","kind":"term","name":"Screening","route":"/terms/screening/"}],"trial":[{"id":"ascend-cancerseek","kind":"trial","name":"ASCEND (CancerSEEK case-control collection)","route":"/trials/ascend-cancerseek/"},{"id":"falcon-registry","kind":"trial","name":"Falcon Registry (Exact Sciences multi-cancer test real-world evidence)","route":"/trials/falcon-registry/"}],"paper":[{"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-cancerguard-mp-classifier-cebp-2026","kind":"paper","name":"Performance of a multi-biomarker class, multi-cancer early detection (MCED) blood test in a prospectively collected cohort","route":"/key-papers/paper-cancerguard-mp-classifier-cebp-2026/"}]}}