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Genetron Health Obtains Regulatory Approval in China for NGS Instrument, Lung Cancer Panel

NEW YORK – Genetron Health, a Chinese cancer molecular profiling and sequencing technology company, said Thursday that it has received approval from the China National Medical Products Administration for a next-generation sequencing system and a kit for an eight-gene lung cancer panel.

The Genetron S2000 is a high-throughput, automated sequencer that can run two types of flow cells, with data output of 55 Gb to 1,440 Gb per run.

The lung cancer panel, which is compatible with the company's Genetron S5 sequencer and the Genetron Chef template preparation system, covers EGFR, ALK, ROS1, BRAF, KRAS, HER2, MET, and PIK3CA.

The S2000 is the second Genetron instrument to receive NMPA approval, following the S5 benchtop instrument, based on the Thermo Fisher Scientific Ion GeneStudio S5 system for targeted NGS, last year.

Genetron, based in Beijing, was founded in 2015 and focuses on cancer molecular profiling. It has diagnosis and monitoring, early screening, and development services business units.