Illumina Launches MiSeq™Dx Sequencing System in China, Empowering Precision Diagnostics with Regulatory Milestone

In recent years, precision medicine has developed rapidly, with numerous domestic and international companies showing undiminished enthusiasm for gene sequencing research. As the application scenarios of sequencing technology continue to expand, Illumina, a global leader in gene sequencing technology, has also set its sights on clinical markets such as reproductive health and oncology. In Illumina’s second financial report, growth in the clinical market was significant, with the oncology clinical market being particularly noteworthy. As a top-tier global company in the field of gene sequencing, Illumina has been committed to advancing the integration of gene sequencing technology into clinical practice. In August 2018, the MiSeq™Dx Gene Sequencing System successfully received approval from the National Medical Products Administration (NMPA), becoming the first next-generation sequencing (NGS) platform to be certified by three authoritative bodies: the U.S. Food and Drug Administration (FDA), the NMPA, and the European Union CE-IVD.

Today, the MiSeq™Dx Gene Sequencer has officially launched in China. On September 16, 2018, the "MiSeq™Dx Gene Sequencer China Launch Event" was successfully held in Beijing.Ms. Kathy Davy, Global Vice President of Illumina; Mr. Wang Gang, Global Product Lead for Illumina MiSeq™ Dx; Mr. Ni Tao, Marketing Director for Greater China at Illumina; Mr. Fang Guohong, General Manager of Clinical Business Sales for Greater China at Illumina; Ms. Chen Zhenyu, Marketing Director of Clinical Business for Greater China at Illumina; Mr. Han Yusheng, President of Burning Rock Biotech; Professor Bu Hong from the Department of Pathology, West China Hospital, Sichuan University; Professor Liang Zhiyong from the Department of Pathology, Peking Union Medical College Hospital; and Professor Wang Jie from the Cancer Hospital, Chinese Academy of Medical Sciences, along with other experts from various fields, attended the launch event to jointly witness this historic moment.

Professor Bu Hong, Department of Pathology, West China Hospital, Sichuan UniversityOpening remarks were delivered, congratulating the launch of the MiSeq™ Dx Genetic Sequencer on behalf of China’s molecular pathology community. Professor Bu Hong stated that the MiSeq™ Dx Genetic Sequencer and its accompanying tumor detection kits would undoubtedly provide a significant boost to precision testing in China. He called for intensified efforts across all sectors to cultivate more professional bioinformatics analysts and foster close collaboration, jointly advancing the development of precision medicine in China as a shared endeavor. Subsequently, numerous clinical experts, including Professor Liang Zhiyong from the Department of Pathology at Peking Union Medical College Hospital and Professor Wang Jie from the Cancer Hospital of the Chinese Academy of Medical Sciences, delivered speeches or sent video messages to congratulate the launch of the MiSeq™ Dx Genetic Sequencer, sincerely expressing their hope that Illumina would bring more high-quality products to the Chinese clinical market.

At the press conference,Mr. Wang Gang, Global Product Lead for MiSeq™ DxandMs. Kathy Davy, Global Vice President of IlluminaThis section introduces the key features of the MiSeq™Dx Genetic Sequencer and Illumina’s global development strategy for the clinical market. Subsequently,Mr. Hans Yusheng, President of Burning Rock BiotechThe presentation also shared experiences and the journey involved in submitting regulatory applications for tumor NGS kits based on the MiSeq™Dx Gene Sequencing System. Han Yusheng further revealed that the approval of the first tumor NGS kit is merely the beginning, with additional NGS-based certifications currently under application.

At this press conference, in addition to the launch of this sequencer,MiSeq™ Dx Genetic Sequencer China Strategic Partner Launch Ceremonyalso held at the conference. FromAmoy Diagnostics, ZhenGu Bio, Burning Rock Biotech, Geneseeq Technology, YuanMa Gene, Zhenhe Technology, Jiabao RenheRepresentatives from seven companies attended the launch ceremony, inaugurating an ecosystem centered on instrument platforms and core reagents that provides comprehensive solutions.

Ms. Kathy Davy told Sequencing China,Illumina will expand its global clinical market with an open vision. The company has currently achieved in-depth development in areas such as reproductive health, oncology, and genetic diseases. Oncology will remain one of the core focuses for its future clinical market expansion, while other fields, such as clinical microbiology, will also become key priorities for future growth.。

The approval of the MiSeqDx Genetic Sequencer in China marks a significant milestone for Illumina’s expansion in the Chinese clinical market, creating broader development opportunities for next-generation sequencing (NGS) and substantially accelerating its clinical application in the country. We look forward to the future approval of more NGS instruments and diagnostic products, ultimately benefiting patients in China.