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MGI Receives CE Mark, Regulatory Clearance in Asia-Pacific Countries for Several Sequencers

NEW YORK – MGI Tech said on Monday 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 terabases 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 terabases per run and an average run time of approximately 38 hours. The G50 is a medium-throughput instrument, offering 60 gigabases 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.

Illumina has filed numerous patent infringement lawsuits in Europe against MGI and other BGI Group subsidiaries concerning the firm's sequencers. Last week, Illumina said that it has sued MGI in the UK and in Sweden, alleging that the DNBSEQ-T7 and -G400 infringe patents covering Illumina's sequencing-by-synthesis chemistry. Illumina has also sued BGI or its subsidiaries in Denmark, Germany, Switzerland, and Turkey, as well as in the US, where BGI has launched countersuits.