NMPA

The companies collaborated in Wuhan during the COVID-19 outbreak, using Darui's pathogenic microorganism detection kits on Genetron's next-generation sequencer.

The company said the kit can provide results within 90 minutes, with sensitivity and specificity of detection reaching the level of traditional PCR methods.

The kit, which is CE marked, is designed to detect the virus' ORF1ab, N, and E genes, and can process 96 samples within two hours.

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 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.

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.