Recently, China’s National Medical Products Administration (NMPA) officially released the “Standards for High-throughput Sequencers” (No. YY/T 1723-2020). This is the first national standard for gene sequencing in the medical device industry and also the first international standard for gene sequencers, highlighting China’s leadership and advancement in the field of gene sequencing. The standard was initiated by the National Institutes for Food and Drug Control (Center for Medical Device Standards Management of NMPA, National Institute for Drug Control) with participation from MGI Tech Co., Ltd. and other major domestic R&D units including Guangzhou DARUI Biotechnology Co., Ltd., Beijing Institute of Medical Device Testing (BIMT), Dongguan CapitalBio Genomic Technology Co., Ltd., Tianjin Novogene Bioinformatic Technology Co., Ltd., Hangzhou Beiruihekang Genomics Diagnostics Technology Co., Ltd., and Annoroad Gene Technology (Beijing) Co., Ltd.
Overview of the standards
The newly released standards cover the application scope, normative references, classification, requirements, test methods, labels and instructions, packaging, transportation, storage, and references for high-throughput sequencers. Their official approval signals that clinical applications of gene sequencers are reaching maturity, establishing a solid foundation for industry norms and wider adoption of sequencing technology.
Growing demand during COVID-19
The global COVID-19 pandemic has accelerated demand for high-throughput sequencers. MGI’s advanced sequencers have been instrumental in epidemic prevention and control worldwide.
MGI sequencing platforms
MGI’s devices include the DNBSEQ-T7, which offers the world’s highest daily throughput, as well as the MGISEQ-2000 and MGISEQ-200 models. These platforms not only support detection of novel coronavirus but also monitor potential mutations, providing critical data for early detection, isolation, diagnosis, and treatment.
Applications across industries
High-throughput sequencing is increasingly important across medicine, healthcare, environment and agriculture. However, the lack of mature standards for R&D and clinical use has posed risks. The new standards, developed through rigorous scientific verification, address this gap and promote safer, more reliable applications.
Impact and future direction
The release of these standards will support comprehensive standardisation of genetic testing products, with sequencing technology at the core. As sequencing costs fall and usability improves, the depth and breadth of applications continue to grow.
As the domestic leader, MGI has developed a complete portfolio of high, medium and low throughput sequencers, along with library prep reagents, sequencing reagents, analysis software and other supporting products. MGI will continue to drive innovation in sequencing technology to meet the evolving needs of research and clinical applications, contributing to the advancement of life science and biotechnology.
