{"entity":{"id":"gutseer","kind":"drug","name":"GutSeer","aka":[],"tldr":"Singlera and Fudan University's blood test for five digestive-system cancers, which found about eight in ten of them in hospital patients but flagged about one in eighteen people without cancer.","summary":"In the GUIDE study (Huang et al., Molecular Cancer 2025; NCT05431621), GutSeer was trained and validated on 1,057 cancer patients and 1,415 controls (82.8% sensitivity, 95.8% specificity; colorectal 92.2%, oesophageal 75.5%, gastric 65.3%, liver 92.9%, pancreatic 88.6%) and then tested blind in 846 hospital inpatients and outpatients at five hospitals, with 81.5% sensitivity and 94.4% specificity; it also detected some advanced precancerous lesions of the colorectum, oesophagus and stomach. Singlera Genomics co-developed it. No regulatory status, availability or price was found.","status":"emerging","asOf":"2026-11-03","links":[{"label":"Huang et al., Molecular Cancer 2025 (GUIDE)","url":"https://doi.org/10.1186/s12943-025-02367-x"},{"label":"ClinicalTrials.gov NCT05431621","url":"https://clinicaltrials.gov/study/NCT05431621"}],"tags":["test","mced","evidence:insufficient"],"related":["panseer","epipangi-dx"],"cancers":["colorectal","esophageal","gastric","hcc","pancreatic"],"sections":[],"technologies":["mced","liquid-biopsy","cfdna-methylation-testing","fragmentomics"],"targets":[],"drugs":[],"companies":["singlera"],"institutions":["zhongshan-hospital-fudan"],"pathways":[],"terms":[],"trials":["guide-gutseer"],"people":[],"bottlenecks":[],"keyPapers":["paper-gutseer-guide-mol-cancer-2025"],"journals":[],"dependsOn":[],"notes":["Evidence grade insufficient for the claim that taking this test reduces late-stage diagnosis or cancer deaths: no randomised trial of it has reported either outcome, and its published performance comes from case-control or single-arm studies. The only randomised result for any multi-cancer test, NHS-Galleri, did not show fewer stage III or IV cancers.","At about 94 to 96% specificity, roughly 1 in 20 people without cancer would test positive.","What a result means: a positive result is a reason for further tests, not a diagnosis; a negative result does not rule cancer out and does not replace the screening tests that have been shown to work (bowel, breast, cervical and, where eligible, lung screening)."],"brand":"GutSeer","modality":"Gastrointestinal multi-cancer blood test (cell-free DNA methylation and fragmentomics)","mechanism":"A targeted bisulphite sequencing panel of 1,656 methylation markers, read together with fragment patterns, for five digestive cancers and their organ of origin.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/gutseer/","neighbours":{"drug":[{"id":"epipangi-dx","kind":"drug","name":"EpiPanGI Dx","route":"/drugs/epipangi-dx/"},{"id":"panseer","kind":"drug","name":"PanSeer","route":"/drugs/panseer/"}],"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"gastric","kind":"cancer","name":"Gastric & gastro-oesophageal junction cancer","route":"/cancers/gastric/"},{"id":"hcc","kind":"cancer","name":"Hepatocellular carcinoma","route":"/cancers/hcc/"},{"id":"esophageal","kind":"cancer","name":"Oesophageal cancer","route":"/cancers/esophageal/"},{"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":"fragmentomics","kind":"technology","name":"cfDNA fragmentomics","route":"/technologies/fragmentomics/"},{"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":"singlera","kind":"company","name":"Singlera Genomics","route":"/companies/singlera/"}],"institution":[{"id":"zhongshan-hospital-fudan","kind":"institution","name":"Zhongshan Hospital, Fudan University","route":"/institutions/zhongshan-hospital-fudan/"}],"trial":[{"id":"guide-gutseer","kind":"trial","name":"GUIDE (molecular models for early diagnosis of digestive cancers, Zhongshan Hospital and Singlera)","route":"/trials/guide-gutseer/"}],"paper":[{"id":"paper-gutseer-guide-mol-cancer-2025","kind":"paper","name":"GUIDE: a prospective cohort study for blood-based early detection of gastrointestinal cancers using targeted DNA methylation and fragmentomics sequencing","route":"/key-papers/paper-gutseer-guide-mol-cancer-2025/"}]}}