Burning Rock Dx

Burning Rock Dx (NASDAQ: BNR) is a global diagnostics company focusing on applying next-generation sequencing (NGS) technology in precision oncology. Guided by the mission of “Guard Life via Science,” Burning Rock offers solutions covering the entire precision oncology development cycle through an internally developed NGS-based assay portfolio for both tissue and blood samples, along with a robust in-house database to help facilitate clinical trial studies and research. Burning Rock provides dedicated services to pharmaceutical partners, encompassing genomic data solutions, clinical trial solutions, precision patient recruitment, and companion diagnostics (CDx) development and commercialization.


Burning Rock’s diverse portfolio operates out of their two CLIA/CAP laboratories in China and the United States, allowing for global clinical trial support. Burning Rock has achieved two NMPA-approved IVD kits, four assays with CE marking, and a breakthrough device designation (BDD) received from both US FDA and China NMPA for multi-cancer detection blood test. Leveraging their robust NGS technology and extensive experience in pharmaceutical and project partnerships, Burning Rock stands as a global collaborator in driving advancements in precision oncology.


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

Burning Rock Dx, LLC’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, LLC has a 20,000 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 Xingdaohuan North Road, International Biotech Island, Guangzhou, China

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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