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Genetron Health Gets CE Mark for Coronavirus PCR Test

NEW YORK – Chinese cancer genomic profiling firm Genetron Health said on Tuesday that its Detection Kit for Novel Coronavirus (SARS-CoV-2) RNA (PCR-Fluorescence Probing) has received the CE mark.

The company also said that three of its clinical laboratories have passed a COVID-19 external quality assessment by China's National Center for Clinical Laboratories (NCCL).

Moreover, Genetron has donated its Genetron S5 sequencing system and supporting instruments to Wuhan Huoshenshan Hospital, where they will be used to generate coronavirus genomic data from clinical COVID-19 samples as part of clinical and epidemiology research.

Genetron, headquartered in Beijing, focuses on cancer molecular profiling and has been collaborating with more than 400 hospitals as well as several dozen biopharmaceutical companies and research institutions. In February, the firm said that the China National Medical Products Administration (NMPA) approved its Genetron S2000 sequencing platform and a lung cancer sequencing panel. Last year, the NMPA also approved Genetron's S5 sequencer, which is based on Thermo Fisher Scientific's Ion GeneStudio S5.

Genetron operates research and development centers in the US and in China, two manufacturing facilities in China, and five clinical laboratories in Beijing, Shanghai, Hangzhou, Chongqing, and Guangzhou.