US CLIA/CAP lab:
1. Address: 121 Innovation Dr STE 100 Irvine CA 92617
The lab is conveniently located on University of California, Irvine campus and next to the Biomedical Research Center. The location is right of highway 73 and only 3.5 miles from the John Wayne Airport.
2. Burning Rock Dx, LLC was established in 2019 in Irvine, CA. The company aims to transform precision oncology, early cancer detection and MRD testing. Its business consists of
•NGS-based therapy selection testing for late-stage cancer patients.
•Global pharmaceutical services on biomarker detection and companion diagnostics developing.
•NGS-based cancer early detection, which has moved beyond proof-of-concept R&D into the clinical validation stage.
•Minimal residual disease (MRD) product for detection of pre-operative ctDNA and post-operative MRD calling and monitoring among relapsed patients.
•COVID-19 clinical testing,
•Clinical research services on molecular diagnostic devices for FDA registration.
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(Chinese Invention Patent No. ZL 201510333111.9) laboratory information management system and expansive genomic databases. Burning Rock’s proprietary High Sensitivity, or HS, library preparation technology allows the company to work with poor quality and limited volume samples and enables enhanced sensitivity capabilities that are critical to effectively deploying NGS-based cancer genotyping.
Burning Rock Dx, LLC has a 20,000 Sq.Ft. research and development and manufacturing facility located in Irvine, CA, U.S. Burning Rock is in compliance with ISO13485 and its testing lab is certified under the U.S. Clinical Laboratory Improvement Amendments (CLIA), accredited by the U.S. College of American Pathologist (CAP).
3. Medical Director:
Our CLIA director, Dr. Daniel Chen, MD. PhD, provides oversight of patient test reports. Dr. Chen has more than 25 years of professional experience in the field of molecular genetics and is a practicing physician in the State of California. Dr. Chen has extensive experience in COVID-19 testing and test development starting from the beginning of the pandemic.
1.121 Innovation Dr STE 100 Irvine CA 92617
China CLIA/CAP lab:
Burning Rock currently operate 3 labs, in addition to the CLIA / CAP laboratory in the United States, we have a CLIA / CAP / ISO 15189 lab in Guangzhou which also obtained the technical certification of “High-throughput sequencing laboratory” issued by Guangdong Center for Clinical Laboratory, up to now, it has passed more than 200 inter-laboratory quality evaluations organized by NCCL, PQCC, EMQN, CAP and other authoritative organizations. And a lab in Shanghai with R&D and NGS capability.