{"entity":{"id":"totem-genecast","kind":"drug","name":"TOTEM (Genecast)","aka":[],"tldr":"Genecast's methylation blood test for seven cancers, which found about two in three cancers in a laboratory set; the developers say it still needs a large prospective study.","summary":"In Xiong et al. (BMC Cancer 2024; 500 healthy controls and 733 patients with breast, colorectal, oesophageal, gastric, liver, lung or pancreatic cancer, plus an independent cohort of 143 controls and 179 liver or stomach cancer patients), TOTEM had 67.3% sensitivity at 100% specificity in testing and 55.9% at 98.6% in independent validation, with 45.7% early-stage (I and II) sensitivity in testing; the top predicted origin was correct in about three quarters of detected cancers. Genecast Biotechnology, of Wuxi, co-developed it. No regulatory status, availability or price was found.","status":"emerging","asOf":"2026-11-03","links":[{"label":"Xiong et al., BMC Cancer 2024","url":"https://doi.org/10.1186/s12885-024-12626-7"}],"tags":["test","mced","evidence:insufficient"],"related":[],"cancers":[],"sections":[],"technologies":["mced","liquid-biopsy","cfdna-methylation-testing"],"targets":[],"drugs":[],"companies":["genecast"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-totem-genecast-bmc-cancer-2024"],"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.","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":"TOTEM","modality":"Multi-cancer early detection blood test in development (cell-free DNA methylation markers)","mechanism":"Enzymatic-conversion targeted methylation sequencing of 57 diagnostic and 873 origin markers in plasma cell-free DNA.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/totem-genecast/","neighbours":{"technology":[{"id":"cfdna-methylation-testing","kind":"technology","name":"Cell-free DNA methylation tests","route":"/technologies/cfdna-methylation-testing/"},{"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":"genecast","kind":"company","name":"Genecast Biotechnology","route":"/companies/genecast/"}],"paper":[{"id":"paper-totem-genecast-bmc-cancer-2024","kind":"paper","name":"TOTEM: a multi-cancer detection and localization approach using circulating tumor DNA methylation markers","route":"/key-papers/paper-totem-genecast-bmc-cancer-2024/"}]}}