MGI announced today that it has the market clearance for its G and T Series sequencers in Asia Pacific countries and Europe.
Its DNBSEQ-T7, DNBSEQ-G400 and DNBSEQ-G50 sequencers are now cleared in European countries recognizing the CE-IVD mark and ready to position in clinical settings. The European IVD CE Mark approval opens up a wider global market with growing potential in clinical settings and enables MGI to serve more large-scale population sequencing projects, especially for DNBSEQ-T7.
With its powerful processing capability, DNBSEQ-T7 has the highest daily data output capacity of any DNA sequencer, with 60 human genomes per day. Designed for clinical and large-scale applications, it can support larger-scale population genomic health projects with Whole Genome Sequencing (WGS), clinical research with Whole Genome Exome Sequencing (WES) and more. MGI’s G series sequencers (DNBSEQ-G400 and DNBSEQ-G50) are benchtop sequencers with unique flexibility and adaptability to a variety of applications.
In the APAC market, MGI G Series sequencers, such as DNBSEQ-G400/50 along with products in the same family, now also have regulatory approvals in China, Japan, Australia, Singapore, Malaysia, Thailand and Vietnam for market clearance.
“Regulatory clearance for MGI’s G and T Series sequencers is a huge milestone for MGI,” said Mu Feng, MGI’s Chief Executive Officer. “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 the clinical use.