NEW YORK – MGI Tech said last week that its DNBSeq-G99 sequencer has been approved as a medical device by China's National Medical Products Administration (NMPA).
With the NMPA approval, the platform can now be used in clinical applications for DNA and RNA sequencing in China, "further augmenting the company’s competitiveness," according to a company filing with the Shanghai Stock Exchange last Friday.
Launched in September 2022, DNBSeq-G99 is an ultra-high-speed, mid-to-low throughput sequencer with a run time of 12 hours for generating 150-base paired-end reads (PE150).
The NMPA approval follows previous medical device registrations of the platform in the EU, Australia, Singapore, Japan, Thailand, and the UK, MGI said.