{"entity":{"id":"gagome-mced-test","kind":"drug","name":"Elypta GAGome multi-cancer test","aka":["GAGome test","free GAGome MCED test","MIRAM GAGome"],"tldr":"A test in development from Elypta in Sweden that reads sugar molecules in urine and blood rather than DNA, aiming to flag many cancers including some that DNA tests find hard to see.","summary":"Elypta's founding study (Bratulic et al., PNAS 2022; 2,064 samples from 1,260 people, 14 cancer types) reported areas under the curve of 0.83 to 0.93, up to 62% stage I sensitivity at 95% specificity, and 89% accuracy for the putative location; in a screening-like validation at 99% specificity it detected 43% of cancers with poor prognosis within 18 months, 21% at stage I (121 and 49 cases).\n\nElypta reported interim LEVANTIS-0087A results on 8 April 2024 in 2,054 adults, saying the urine test predicted 80% more adults who would develop cancer than age and sex alone, up to six years before diagnosis; that is a company statement, not a peer-reviewed figure. Validation studies are LEVANTIS-0087A in Sweden (NCT05235009), LEVANTIS-0093A in heavy smokers in Yorkshire (NCT05295017) and a firefighter study in the US (NCT05780957). Elypta states ISO 13485 certification and supplies GAGome kits for research use; no CE or IVDR marking of a multi-cancer product and no price were found.","status":"emerging","asOf":"2026-10-29","links":[{"label":"Bratulic et al., PNAS 2022","url":"https://doi.org/10.1073/pnas.2115328119"},{"label":"Elypta: interim LEVANTIS-0087A results (8 April 2024)","url":"https://www.elypta.com/news/elypta-interim-study-results-show-glycosaminoglycan-potential-to-predict-the-risk-of-developing-any-type-cancer-with-a-simple-urine-test"}],"tags":["test","mced","evidence:insufficient"],"related":[],"cancers":[],"sections":[],"technologies":["mced","liquid-biopsy"],"targets":[],"drugs":[],"companies":["elypta"],"institutions":[],"pathways":[],"terms":[],"trials":["lev87a","lev93a","vincere-firefighters-mced"],"people":[],"bottlenecks":[],"keyPapers":["paper-bratulic-gagome-pnas-2022"],"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":"GAGome","modality":"Multi-cancer early detection test in development (urine and plasma glycosaminoglycans)","mechanism":"Measures the profile of free glycosaminoglycans, sugar chains that tumours' altered metabolism changes, in urine and plasma, and scores it with machine learning; it also predicts the likely cancer location.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/gagome-mced-test/","neighbours":{"technology":[{"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":"elypta","kind":"company","name":"Elypta","route":"/companies/elypta/"}],"trial":[{"id":"lev87a","kind":"trial","name":"LEVANTIS-0087A (GAGome test in adults without symptoms)","route":"/trials/lev87a/"},{"id":"lev93a","kind":"trial","name":"LEVANTIS-0093A (GAGome test in high-risk adults)","route":"/trials/lev93a/"},{"id":"vincere-firefighters-mced","kind":"trial","name":"Multi-cancer early detection in firefighters (Vincere Cancer Center)","route":"/trials/vincere-firefighters-mced/"}],"paper":[{"id":"paper-bratulic-gagome-pnas-2022","kind":"paper","name":"Noninvasive detection of any-stage cancer using free glycosaminoglycans","route":"/key-papers/paper-bratulic-gagome-pnas-2022/"}]}}