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NMPA

The high-throughput S2000 sequencer is the second instrument Genetron Health has received NMPA approval for, following the S5 benchtop instrument last year.

The firm said that its Verigene II multiplex system is on track to launch in mid-2020 among a number of new products scheduled for release this year. 

The firm submitted its Verigene II Gastrointestinal Flex Assay to the FDA in Q4 and expects to submit Verigene II Respiratory Flex Assay to the agency in Q1 2020.

The DNBSEQ-T7 ultra-high-throughput sequencer, metagenomic sequencing kit for coronaviruses, and 2019-nCoV RT-qPCR kit have received authorization from China's NMPA.

Cytek said the reagents consist of basic T, B, and NK cell cluster of differentiation markers used for lymphocyte subset detection.

The Genetron Health S5 NGS system is based on the Thermo Fisher Scientific Ion GeneStudio S5 and will be accompanied by Genetron-developed assays.

The approval allows the company to directly market and sell the CTC technology to labs and other institutions to develop and implement IVD tests.

Labs in China can now use the Cobas EGFR Mutation Test v2 with either tissue or plasma samples as a CDx for three Roche oncology drugs in NSCLC patients.

The company said that the DxA 5000 reduces the number of required manual steps and can shorten the preanalytical processing time by up to 73 percent.

For 2019, the firm's total revenues from commercial operations, licensing, and collaborations are expected to grow to more than €3 million.

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