{"entity":{"id":"overc-mcdbt","kind":"drug","name":"OverC Multi-Cancer Detection Blood Test","aka":["OverC MCDBT","MCDBT-1"],"tldr":"Burning Rock's methylation blood test from China for five or six cancers, with Breakthrough designations from the US and Chinese regulators but no approval yet.","summary":"In THUNDER (Gao et al., Annals of Oncology 2023; NCT04820868), the model behind OverC, validated in an independent prospective set of 1,010 people (505 with cancer), had 69.1% sensitivity, 98.9% specificity and 83.2% tissue-origin accuracy for six cancers (colorectum, oesophagus, liver, lung, ovary, pancreas); sensitivity for stages I to III was 59.8%, and the abstract gives no stage I figure or positive predictive value. In PROMISE (Duan et al., The Innovation 2026; NCT04972201), adding protein markers to methylation raised sensitivity to 75.1% at 98.8% specificity across nine cancers.\n\nBurning Rock's 2025 annual report (20-F) gives the intended use filed with the FDA and NMPA as esophageal, liver, lung, ovarian and pancreatic cancer in adults aged 50 to 75 at average risk (elsewhere it lists six cancers including colorectal), states Breakthrough Device designation by the FDA in January 2023 and by the NMPA in October 2023, lists OverC among CE-marked products (CE marking announced May 2022), and describes contracts with a small number of pilot hospitals in China. No approval by the FDA or NMPA and no price were found. PREVENT (NCT05227534), in people without symptoms, had enrolled about 5,000 by the company's account; no results were found.","status":"emerging","asOf":"2026-10-29","links":[{"label":"Gao et al., Annals of Oncology 2023 (THUNDER)","url":"https://doi.org/10.1016/j.annonc.2023.02.010"},{"label":"Burning Rock 2025 annual report (SEC 20-F)","url":"https://www.sec.gov/Archives/edgar/data/1792267/000119312526183377/d31568d20f.htm"}],"tags":["test","mced","evidence:insufficient"],"related":[],"cancers":[],"sections":[],"technologies":["mced","liquid-biopsy","cfdna-methylation-testing"],"targets":[],"drugs":[],"companies":["burning-rock"],"institutions":[],"pathways":[],"terms":[],"trials":["thunder-overc","predict-overc","prevent-overc","promise-cams"],"people":[],"bottlenecks":[],"keyPapers":["paper-gao-thunder-ann-oncol-2023","paper-promise-innovation-2026"],"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":"OverC","modality":"Multi-cancer early detection blood test (cell-free DNA methylation, ELSA-seq)","mechanism":"Targeted cell-free DNA methylation sequencing (enhanced linear-splinter amplification sequencing) over about 162,000 CpG sites, reporting a cancer signal and predicted tissue of origin.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2023-01-03","type":"designation","region":"US","note":"FDA Breakthrough Device designation for the OverC multi-cancer detection blood test (company announcement)","source":"https://www.biospace.com/burning-rock-received-fda-breakthrough-device-designation-for-its-overc-multi-cancer-detection-blood-test"},{"date":"2023-10","type":"designation","region":"China","note":"NMPA breakthrough (innovative device) designation, as stated in Burning Rock's 2025 annual report","source":"https://www.sec.gov/Archives/edgar/data/1792267/000119312526183377/d31568d20f.htm"}]},"route":"/drugs/overc-mcdbt/","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":"burning-rock","kind":"company","name":"Burning Rock Biotech","route":"/companies/burning-rock/"}],"trial":[{"id":"predict-overc","kind":"trial","name":"PREDICT (Burning Rock pan-cancer early detection project)","route":"/trials/predict-overc/"},{"id":"prevent-overc","kind":"trial","name":"PREVENT (OverC in people without symptoms)","route":"/trials/prevent-overc/"},{"id":"promise-cams","kind":"trial","name":"PROMISE (pan-cancer liquid biopsy proof of concept, Chinese Academy of Medical Sciences)","route":"/trials/promise-cams/"},{"id":"thunder-overc","kind":"trial","name":"THUNDER (blinded validation of Burning Rock's methylation test)","route":"/trials/thunder-overc/"}],"paper":[{"id":"paper-promise-innovation-2026","kind":"paper","name":"Exploration of multi-omics liquid biopsy approaches for multi-cancer early detection: The PROMISE study","route":"/key-papers/paper-promise-innovation-2026/"},{"id":"paper-gao-thunder-ann-oncol-2023","kind":"paper","name":"Unintrusive multi-cancer detection by circulating cell-free DNA methylation sequencing (THUNDER): development and independent validation studies","route":"/key-papers/paper-gao-thunder-ann-oncol-2023/"}]}}