Recently, China’s National Medical Products Administration officially released the “Standards for High-throughput Sequencers” (No. YY/T 1723-2020), which is the first national standard for gene sequencing in the medical device industry and the first international standard for gene sequencers, demonstrating China's forward-looking and advancement in the field of gene sequencing. The standard was initiated by National Institutes for Food and Drug Control (Center for Medical Device Standards Management of NMPA, National Institute for Drug Control), the first drafting unit, with participation by MGI Tech Co., Ltd. (the second drafting unit), as well as 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.

“Standards for High-throughput Sequencers” (No. YY/T 1723-2020)

The newly released Standards for High-throughput Sequencers include the application scope of the standard, normative references, classification, requirements, test methods, labels and instructions for use, packaging, transportation, storage and references of high-throughput sequencers. Its official approval indicates that the clinical application of gene sequencer and gene sequencing technology is gradually entering a mature stage, which lays a strong foundation for the development of industry norms and the wide application of sequencing technology. At the same time, the release of the standard will enable the clinical application of more gene sequencing technologies and products for the benefit of the public.

As COVID-19 continues to spread, the demand for high-throughput gene sequencers is growing rapidly

With the ongoing COVID-19 global pandemic, the demand for epidemic prevention products in relevant countries is growing rapidly, and the high-throughput sequencer is an important tool. MGI, for example, has its own advanced high-throughput gene sequencers and has played a powerful role in the epidemic prevention and control around the world.

DNBSEQ-T7

These gene sequencers include DNBSEQ-T7 with the world’s highest daily throughput, as well as MGISEQ-2000, MGISEQ-200 and other models. These devices can help not only to diagnose the existence of novel coronavirus, but also to monitor possible mutations, providing accurate information needed for epidemic prevention and control measures of  “early detection, early isolation, early diagnosis and early treatment.”

Korea Institute of Basic Sciences RNA Research Center and Seoul National University and others release high-definition mapping of the COVID-19 transcriptome and epigenetic transcriptome based on DNBSEQ-G50 platform

High-throughput sequencers also play an important role in various fields such as medicine, health, environment and agriculture. The clinical demand for this technology is growing. Yet a lack of mature standards for the R&D and use of sequencing platforms at home and abroad makes it difficult to control the risk in clinical use, and the need for industry standards has become more urgent.

Therefore, National Institutes for Food and Drug Control, with participation by MGI and other major domestic R&D units, initiated the new “Standards for High-throughput Gene Sequencers.” After scientific verification of the feasibility and rationality of each clause, the standards were officially approved and published.

The release of the new standards will promote more comprehensive standardization of genetic testing products, with high-throughput sequencing technology as the core. The cost of sequencing is falling sharply, the usability of the system is constantly improving, and the depth and breadth of sequencing applications is growing.

As the leader of domestic sequencers, MGI has formed a comprehensive portfolio of high, medium and low throughput equipment, and independently developed a series of complete gene sequencing products, including library prep reagents, sequencing reagents, analysis software and other supporting products. In the future, MGI will continue to seek breakthroughs and innovations in sequencing technology to meet the demands of scientific research and clinical applications, contributing to advancing the life science and technology industry.