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Burning Rock Dx

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.


US CLIA/CAP lab:
Address: 121 Innovation Dr STE 100 Irvine CA 92617

Burning Rock’s platform integrates cutting-edge proprietary cancer genotyping technologies for both tissue and liquid biopsies, including assay biochemistry, bioinformatics, a patented laboratory information management system and expansive genomic databases. Burning Rock Dx has a over 13,000  Sq.Ft. of Research and Development and a high-complexity  laboratory located in Irvine, CA, U.S. Burning Rock is certified under the U.S. Clinical Laboratory Improvement Amendments (CLIA), accredited by the U.S. College of American Pathologist (CAP).

CLIA

CAP

China CLIA/CAP lab:
Address: No. 5, Xingdao Huanbei Road, Guangzhou International Bio Island, Huangpu District, Guangzhou, Guangdong China 510300

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.


CAP

CLIA

ISO15189

ISO13485

NCCL

Company Introduction

We collaborate with mutual trust and authenticity, exceeding expectations to help others achieve a shared vision and value.

US-lab Introduction
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