MGI has obtained the Medical Device Registration Certificate (MDRC) from the China Food and Drug Administration (CFDA) for its next-generation sequencers MGISEQ-2000 and MGISEQ-200. On 30 June 2014, CFDA approved the registrations of MGI’s first two sequencers, making MGI the first organisation to receive certification for next-generation sequencing diagnostic products and medical devices.
Since then, four of MGI’s genetic sequencers have obtained MDRC, signifying that these platforms are suitable not only for scientific research but also for clinical medicine. Healthcare organisations can confidently use MGI’s sequencing solutions to perform whole genome sequencing (WGS).
In October 2017, MGI launched the MGISEQ-2000 and MGISEQ-200 at the 12th International Conference on Genomics (ICG-12) in Shenzhen.
- MGISEQ-2000 supports two types of Flow Cells and an independent dual flow cell operating platform, offering dozens of operating modes. It can produce 1080G of high-quality sequencing data, and in PE100 mode at full load, it provides end-to-end sequencing within 48 hours.
- MGISEQ-200 is compact and flexible, producing 60G of high-quality sequencing data in PE100 mode within 48 hours. It can process 24 tumour samples in a single day.
MGI continues its mission of applying genomics technology for human benefit. Since acquiring Complete Genomics Inc. (CGI), MGI has rapidly developed a new series of genetic sequencers, including high-flux and desktop sequencing systems, all with full intellectual property rights. MGI has filed over 500 patents, including more than 70 PCT patents.
MGI also provides real-time life digitisation devices and full-service packages, supporting precision medicine, agriculture, and health. Obtaining CFDA certification marks a significant milestone, opening further opportunities in China’s clinical medicine market. MGI will continue developing innovative instruments and equipment to advance life science research and clinical applications.
