Burning Rock Receives CE Mark Approval for Three NGS Tumor KitsVar Date：2022-05-07
Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”) announced that the Company had received CE mark approval for three self-developed next generation sequencing (NGS) kits, namely, “OncoScreen™ Plus Cancer Mutation Profiling Tissue Kit”; “OncoCompass™ Target Cancer Mutation Profiling Liquid Kit”; and “OncoScreen™ Focus CDx Tissue Kit”. The CE mark allows Burning Rock products to be placed on the market in the European Economic Area, and will help Burning Rock consolidate its global product portfolio, enhance its competitiveness, and strengthen its global business strategy.
The three NGS tumor kits cover a wide range of genes and variant types in different panel sizes (large, medium, and small panel size, respectively). They offer a simple blood or tissue test to provide guidance on personalized treatment options for various cancers.
l The OncoScreen™ Plus Cancer Mutation Profiling Tissue Kit is a NGS-based in vitro diagnostic device intended to be used for the qualitative detection of multiple types of mutations involving 518 genes based on formalin-fixed paraffin-embedded (FFPE) tissue samples from patients with various cancers. Mutations include point mutation, insertion-deletion (InDel) mutation, rearrangement (fusion), and copy number variation (CNV), as well as the determination of microsatellite instability (MSI) status and tumor mutation burden (TMB).
l The OncoCompass™ Target Cancer Mutation Profiling Liquid Kit is a qualitative NGS-based in vitro diagnostic device that uses targeted high throughput hybridization-based capture technology for detection of mutations in 101 genes in cell-free DNA extracted from plasma of peripheral whole blood in patients with solid malignant neoplasms. Mutations include single nucleotide mutation (SNV) and InDel in 99 genes, rearrangement (fusion) in 10 genes, and CNV in 13 genes, and MSI.
l The OncoScreen™ Focus CDx Tissue Kit is a qualitative NGS-based in vitro diagnostic device that uses targeted high throughput hybridization-based capture technology for detection of mutations in 13 genes including EGFR/ALK/ROS1/RET/MET/ERBB2/BRAF/PIK3CA/KRAS/NRAS/HRAS/KIT/PDGFRA using DNA extracted from FFPE tissues in patients with non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and gastrointestinal stromal tumor (GIST). Mutations include SNV, InDel, rearrangement (fusion), and CNV.
Burning Rock strives to obtain regulatory approvals globally. In July 2018, the “Human EGFR/ALK/BRAF/KRAS gene mutation detection kit (reversible termination sequencing method)”, developed independently by Burning Rock, became the first NGS-based companion diagnostic (CDx) kit approved by National Medical Products Administration (NMPA) in China. In March 2022, the NMPA approved Burning Rock’s “Human Nine-Gene Mutation Joint Detection Kit” (reversible termination sequencing) (LungCure™ CDx) as a class III medical device, which detects more mutation sites and can benefit more patients with rare targets.
In addition to the series of globally registered products, Burning Rock labs located in Guangzhou, China and California, USA are both Clinical Laboratory Improvement Amendments (CLIA) certified and College of American Pathologists (CAP) accredited. Burning Rock Guangzhou lab has successfully passed the ISO13485 certification, which is a comprehensive certification of the Company’s Quality Management System for the design and development, production, and sales of in vitro diagnostic reagents, software and sample preparation system. Recently, the laboratory in Guangzhou, China also received ISO15189 accreditation, indicating a proficient and quality clinical service that Burning Rock is committed to deliver.
Based on its global product portfolio and authorized laboratories in China and the US, Burning Rock will continue to cultivate the global market in precision medicine, and will strive to provide clinical benefit for cancer patients.