Genetron Health Announces NMPA Approval of its 8-gene Lung Cancer Assay and NGS Platform GENETRON S2000
Genetron Health, a China-based precision oncology company that covers full-cycle cancer care, announced that the National Medical Products Administration (NMPA) has approved its 8-gene Lung Cancer Assay and high-throughput NGS platform GENETRON S2000 to empower comprehensive panel genomic testing for more patients.
The 8-gene Lung Cancer Assay is the first lung cancer clinical testing assay based on Genetron One-Step Seq Method approved by NMPA, offering fast and easy-to-use testing procedures, that is suitable for independent operation within hospitals. With the Genetron One-Step Seq technology, the library construction process is finished in one step of reaction, minimizing manual operation to one mixture of reagents with DNA/cDNA. The chance of contamination in the process is minimal with the “sample in library out” workflow. The assay is compatible with both the Genetron S5 sequencing platform and the Genetron Chef System. The 8-gene Lung Cancer Assay covers EGFR, ALK, ROS1, BRAF, KRAS, HER2, MET, PIK3CA, and 7 genes of them are recommended biomarkers by the 2018 NCCN guideline for Non-Small Cell Lung Cancer (NSCLC) patients.
GENETRON S2000 enables comprehensive genomic testing for high-throughput clinical testing centers such as large hospitals and regional medical testing centers. GENETRON S2000 adopts an innovative Flow Cell system that provides two types of Flow Cells to support various sequencing modes, and an optimized optical and biochemical system which enables the whole sequencing process to complete within a short period of time, offering a simplified and streamlined sequencing experience with a highly-automated process and friendly operating system. The data output could range from 55G to 1440G. With the approved platform, Genetron Health is developing testing solutions covering multi-application scenarios.
Based on patented technologies including the One-Step Seq Method, Genetron Health has developed seven NMPA approved clinical molecular testing equipment or assays on NGS, digital PCR and qPCR platforms, and has now realized full-range sequencing capabilities with the medium-throughput NGS system Genetron S5, featuring 8-gene Lung Cancer Assay, and the high-throughput NGS platform GENETRON S2000, featuring 825-gene Testing Assay.
About Genetron Health
Genetron Holdings Limited (“Genetron Health” or the “Company”) is a leading and fast-growing precision oncology company in China that specializes in cancer molecular profiling. We harness advanced technologies in molecular biology and data science to transform cancer treatment. Driven by our mission to transform cancer treatment and prevention globally by driving technological innovation and accelerating the adoption of precision oncology medicine, we offer our products and services through three business units: diagnosis and monitoring, early screening, and development services. Genetron was founded in 2015 and is based in Beijing, China. For more information, please visit www.genetronhealth.com.