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MGI Obtains Medical Device Registration Certificate from CFDA for Its Two Sequencers

Release date:2018-07-10Writer:MGIViews:1509Share

MGI, a subsidiary corporation of BGI, has obtained the Medical Device Registration Certificate (MDRC) from ChinaFood and Drug Administration (CFDA) for its two next-generation sequencers, MGISEQ-2000 and MGISEQ-200. On June 30, 2014, CFDA approved the registrations of MGI's first two sequencers, which made MGI the first organization to receive the certification from CFDA for next-generation sequencing diagnostic products and medical devices. During this short period of continuous developmental process, four genetic sequencers of MGI have obtained MDRC. Obtaining the MDRC means that these two new sequencers will not only play an important role in scientific research but also in the field of clinical medicine. Healthcare organizations can feel confident using the world's leading enterprise sequencing solution to perform whole genome sequencing (WGS).

In October 2017, MGI launched two new next-generation sequencers, MGISEQ-2000 and MGISEQ-200, at the 12th International Conference on Genomics (ICG-12) in Shenzhen. MGISEQ-2000 supports selection of two different types of Flow Cells and provides an independent dual flow cell operating platform. Users can combine dozens of different operating modes to provide a more diversified choice of space for sequencing work. It can produce 1080G[KH1] of high-quality sequencing data, and in PE100 mode at full load, MGI-2000 can provide single end-to-end sequencing within 48 hours. MGISEQ-200 has convenient and flexible features. It takes less than 48 hours to produce 60G of high-quality sequencing data while functioning in PE100 mode at full load. MGISEQ-200 can complete the rapid test of 24 tumor samples in a day.

As a subsidiary corporation of BGI, MGI adheres to BGI's mission of genomics technology for the benefit of human beings, focusing on the R&D, manufacturing, production, and sales of life science and healthcare instruments and equipment, reagent materials and other relevant products. Since its acquisition of CGI (Complete Genomics Inc.), MGI has built upon its technologies to rapidly develop a new series of genetic sequencers. MGI successively launched four globally advanced systems with full intellectual property rights, including the high-flux sequencing system and the desktop sequencing system. So far, MGI has applied for more than 500 patents, more than 70 of which are patent cooperation treaty (PCT).

MGI also provides real-time life digitization devices with full view and full life cycle and offers independent and controllable advanced devices, technical support and packages to satisfy demand for precision medicine, precision agriculture, precision health, etc. Obtaining this CFDA certification is another significant milestone for MGI and is a huge step towards the clinical medicine market in China. MGI will continue to develop more instruments and equipment in the life science field to provide better support for industry development.

About MGI

MGI is committed to enabling effective and affordable healthcare packages for all people, focusing on the development, production and distribution of devices, equipment, consumables and reagents for life science research and medical healthcare. Providing real time, whole picture and lifelong packages for life digitalization[KH2] , MGI's mission is to develop and promote advanced life science tools for future healthcare. MGI has developed a variety of projects for different platforms, such as genetic sequencing, mass spectrometer, medical imaging and more.

[KH1]Confirm number is 1080G

[KH2]Life digitalization doesn’t make sense in English. Try another way.

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