OncoScreen® Plus Cancer Mutation Profiling Tissue Kit CE-IVDD

Guangdong Guangzhou, China

Burning Rock Dx (NASDAQ: BNR) is a global precision oncology leader specializing in NGS-based diagnostics for both tissue and liquid biopsy. With internationally accredited labs (CLIA, CAP, ISO15189, ISO13485) and deep NGS expertise, the company offers a broad portfolio of in-house assays and integrated solutions across the oncology development cycle. Burning Rock supports pharmaceutical development and decentralized clinical implementation, partnering with biopharma and clinical labs to advance trials, biomarker research, and real-world diagnostics. Key milestones include two NMPA-approved IVD kits, four CE-marked assays, and Breakthrough Device Designations from both the FDA and NMPA for its multi-cancer early detection test. Burning Rock is committed to transforming cancer care through innovative, science-driven solutions. In addition to the CLIA / CAP laboratory in the United States, we have a CLIA / CAP / ISO 15189 / ISO13485 lab in Guangzhou, China, which also obtained the technical certification of “High-throughput sequencing laboratory” issued by the Guangdong Center for Clinical Laboratory. We have passed over 200 inter-laboratory quality evaluations organized by NCCL, PQCC, EMQN, CAP, and other authoritative organizations.