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BGI Sequencer, Coronavirus Molecular Assays Granted Emergency Use Approval in China

NEW YORK – BGI and its subsidiary MGI Tech said this week that their ultra-high-throughput sequencer DNBSEQ-T7, a metagenomic sequencing kit for coronaviruses, and 2019 novel coronavirus (2019-nCoV) reverse transcription PCR kit have all received emergency use approval from China's National Medical Products Administration.

Specifically, MGI's DNBSEQ-T7 sequencer and analysis software received NMPA certification as a Class III medical device to support future epidemic prevention and control, MGI Tech said. The sequencer, which also recently received CE marking, can produce up to 6 terabases of data per run, with an average run time of 24 hours.

The PMseq metagenomics sequencing kit, which runs on the DNBSEQ-T7, also received emergency approval. The kit uses BGI's combinatorial probe-anchor synthesis sequencing technology to rapidly detect viral sequences to identify and diagnose 2019-nCoV and other coronaviruses.

Finally, BGI's real-time fluorescent RT-PCR kit, for specific testing of 2019-nCoV in a few hours' time, also received emergency authorization. BGI said it has scaled up production of the assay and donated 20,000 kits to support the response to the 2019-nCoV outbreak in Wuhan and Hubei Province. BGI also said it has provided about 50,000 test kits in total to hospitals and disease control centers in China.

BGI said it has been authorized as the third-party collaborator by China's National Health Commission to detect 2019-nCoV in the country, and that it has begun discussions with various overseas organizations to supply test kits and sequencing-based solutions to diagnose the virus.