MGI receives CE Mark, regulatory clearance in Asia-Pacific countries for several sequencers

MGI Tech said that it has received the CE-IVD mark for the DNBSEQ-T7, DNBSEQ-G400, and DNBSEQ-G50 instruments, as well as regulatory approval for its G-Series sequencers in several countries in the Asia-Pacific region.

Regulatory clearance for MGI’s G and T Series sequencers is a huge milestone,” MGI CEO Mu Feng said in a statement. “MGI can help to accelerate sequencing projects of any scale and deliver high-quality data with the most adaptable, capable, and efficient sequencer available. It also means that the sequencer’s quality is recognized, validated, and certified for clinical use.

The DNBSSEQ-T7 is a high-throughput instrument that can produce up to 6 terabytes of data per run, with an average run time of 24 hours. The G400 supports whole-genome and whole-exome sequencing, among other applications, with a maximum throughput of approximately 1.4 terabytes per run and an average run time of approximately 38 hours. The G50 is a medium-throughput instrument, offering 60 gigabytes per run, with applications in targeted DNA, RNA, and microbial sequencing.

MGI’s DNBSEQ-G400 and -G50 instruments, formerly known as the MGISEQ-2000 and -200, respectively, have also received clearance in China, Japan, Australia, Singapore, Malaysia, Thailand, and Vietnam, the firm said.


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