GUANGZHOU, China, January 06, 2026-Recently, Burning Rock Dx received authorization from the United States Patent and Trademark Office (USPTO) for the self-developed ultra-sensitive detection technology, ELSA-seq (Patent No. US 12460202 B2). This marks the first U.S. patent granted to ELSA-seq following its patent approval in China, signifying a major milestone. The achievement represents authoritative international recognition of Burning Rock’s innovative liquid biopsy technology.
Currently, Burning Rock’s multi-cancer early detection product OverC®, which is based on the ELSA-seq technology platform, has obtained CE certification and is the only multi-cancer early detection product that has been granted both Breakthrough Device Designation by the U.S. FDA and China NMPA. In addition, leveraging ELSA-seq, the company has developed the tissue-agnostic recurrence monitoring product CanCatch Surf to support precision treatment decision and long-term follow-up for cancer patients. The newly granted U.S. patent will further consolidate the technological foundation and intellectual property protection for the global commercialization of these two products.
ELSA-seq was first unveiled at the AACR Annual Meeting in 2019, with its technology validation study successfully published later that year in Nature Biomedical Engineering. Through continuous technological innovation and rigorous clinical validation, ELSA-seq now offers four core technological advantages and has established a comprehensive body of evidence covering methodology robustness, clinical performance, early cancer detection, and recurrence monitoring.
In the field of early cancer detection, OverC® targets six cancer types*, including liver cancer, lung cancer, esophageal cancer, colorectal cancer, pancreatic cancer, and ovarian cancer. Its superior sensitivity, specificity, and tissue origin performance have been rigorously validated through THUNDER study. Relevant results were published in the journal Annals of Oncology. According to epidemiological model assessments, annual OverC® testing can achieve stage-shifting for 38.7%-46.4% of patients and help improve the five-year survival rate for 33.1%-40.4% of patients.
In the field of recurrence monitoring, CanCatch Surf breaks through the limitations of tissue dependency by analyzing blood-based methylation signals to support reliable treatment solutions. Multiple clinical studies conducted by Burning Rock have demonstrated that CanCatch Surf can predict recurrence risk in Multi-cancers such as lung cancer, colorectal cancer, and liver cancer, even without tissue samples. Relevant research findings have been presented at major international academic conferences including ASCO 2025 and AACR 2025. The latest clinical research results of CanCatch Surf in recurrence prediction in colorectal cancer will be officially released at the ASCO GI 2026 conference.
The granting of the U.S. patent for ELSA-seq not only affirms the originality and technological strength of this innovation, but also further reinforces Burning Rock’s core competitive advantage in the global precision medicine landscape. As the fundamental technology powering both OverC® and CanCatch Surf, ELSA-seq will continue to enable highly sensitive, robust, and reliable liquid biopsy solutions for research and clinical applications, helping deliver better precision care to cancer patients worldwide.
*: The FDA Breakthrough Device Designation for OverC® applies to five cancer types: esophageal, lung, liver, pancreatic, and ovarian, and does not include colorectal cancer
