OverC Multi-Cancer Detection Blood Test

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.

Burning 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.