Genetron Health Launches GENETRON S5: China's First Clinically Approved Semiconductor-Based Desktop NGS Platform
Summary
1. The Genetron S5 is China’s first next-generation sequencing (NGS) desktop platform based on a new generation of semiconductor technology, suitable for clinical use. It offers advantages such as rapid detection, flexible throughput, low input sample requirements, and broad application scope. Its associated tumor gene detection kits have also been successively developed and applied in scientific research.
2. The GENETRON S5 was officially launched with the support and endorsement of leading industry experts, further strengthening Genetron Holdings Limited’s comprehensive portfolio in the IVD sector and marking a significant advancement for China’s gene sequencing and molecular pathology industries.
3. Leveraging the GENETRON S5 platform, Genetron has conducted clinical trials and research collaborations with multiple authoritative institutions, consistently enabling independent NGS clinical testing in hospitals to precisely and efficiently address pain points in clinical applications.
Recently, the promotional and launch events for Genetron’s GENETRON S5 Gene Sequencer (NMPA Registration No. 20193220820; hereinafter referred to as “GENETRON S5”), themed “Expanding New Horizons, Innovating the Future,” were successfully held in Chongqing and Beijing, respectively. The conferences were chaired by Professor Li Jinming, Director of the National Center for Clinical Laboratories under the National Health Commission; Professor Wang Qingtao, Director of the Beijing Center for Clinical Laboratories; and Professor Zhi Xiuyi from the Lung Cancer Diagnosis and Treatment Center of Capital Medical University. Professor Ying Jianming from the Cancer Hospital of the Chinese Academy of Medical Sciences and Professor Zheng Yan from Shandong Cancer Hospital delivered insightful presentations. Under the introductions by Dr. Wang Sizhen, Co-founder and CEO of Genetron Holdings Limited, and executives from Thermo Fisher Scientific (hereinafter referred to as “Thermo Fisher”), attendees jointly witnessed the impressive launch of China’s first next-generation semiconductor-based desktop high-throughput second-generation sequencing platform approved for clinical use.
Group Photo at the GENETRON S5 Launch Event
Group Photo at the GENETRON S5 Launch Event
GENETRON S5 features rapid detection, flexible throughput, low input sample requirements, and a broad range of applications. It specifically addresses key challenges in clinical settings, such as long turnaround times, difficulty in adjusting throughput, insufficient starting sample volumes, and limited instrument applicability. Its accompanying tumor gene detection kits have been sequentially developed and deployed for research purposes. These kits are compatible with various sample types, including tissue and body fluids, and can be applied to multiple cancer types such as glioma, lung cancer, urothelial carcinoma, breast cancer, and thyroid cancer. They cover areas including early cancer screening, molecular subtyping, and treatment guidance.
GENETRON S5
Based on the GENETRON S5 platform, Genetron Holdings Limited has initiated multi-cancer research collaborations with numerous authoritative institutions. Notably, Professor Ying Jianming, as the principal investigator of the GENETRON S5 clinical trials, and Professor Zheng Yan, as a representative collaborator in the research projects, were each invited to share their practical application experiences with the GENETRON S5 at two separate conferences. Both experts emphasized that factors such as turnaround time, throughput, cost, and required input sample volume are key considerations for medical institutions in clinical practice. They noted that, based on long-term collaboration with Genetron, the GENETRON S5 excellently meets clinical demands, demonstrating stable operation and reliable results, thereby significantly promoting the standardized development of clinical molecular pathology testing.
Professor Ying Jianming, Cancer Hospital, Chinese Academy of Medical Sciences
Professor Zheng Yan, Shandong Cancer Hospital
Meanwhile, Genetron Holdings Limited has recently successfully obtained dual certification for ISO 9001 and ISO 13485 quality management systems from the international certification body SGS. This achievement demonstrates that the company adheres to internationally leading quality standards throughout the entire process of design, development, and manufacturing of molecular biological analysis equipment—covering sample processing, molecular subtyping, genetic testing, and result analysis. Backed by a robust, comprehensive lifecycle quality control system, Genetron is well-positioned to provide users with products and services that meet higher standards, deliver superior quality, and offer greater clinical utility.
Dual Certification Certificate for ISO 9001 and ISO 13485 Quality Management Systems
The approval and market launch of the GENETRON S5 not only completes Genetron Holdings’ comprehensive portfolio in the in vitro diagnostics (IVD) sector, but also marks a significant advancement for China’s gene sequencing industry and molecular pathology field. Director Li Jinming stated, “In recent years, the field of molecular testing has developed at an extremely rapid pace. Chronologically, it can be divided into three eras: the 1.0 era of single-gene testing, the 2.0 era of multi-gene testing, and the 3.0 era of multi-omics combined testing. Throughout each stage, next-generation sequencing (NGS) technology has served as a crucial technical tool. The approval of the GENETRON S5 not only provides clinical laboratories with an excellent option, but also adds a powerful instrument to promote the standardization and normalization of molecular pathology testing.”
Director Li Jinming, National Center for Clinical Laboratories, National Health Commission
Director Wang Qingtao stated, “Effective laboratory testing requires collaborative efforts from multiple stakeholders, with robust platforms and advanced technologies being crucial, alongside strengthened quality control and management. We highly anticipate that the GENETRON S5 will deliver more efficient testing workflows, more precise results, and more comprehensive data for clinical molecular diagnostics, thereby advancing precision medicine and serving a broader population of cancer patients.”
Wang Qingtao, Director of Beijing Clinical Laboratory Center
Mr. Tony Acciarito, President of Thermo Fisher Scientific China, stated, “Thermo Fisher Scientific is committed to partnering with customers to make the world healthier, cleaner, and safer. We highly value our long-term collaboration with Genetron Holdings Limited, and we are deeply impressed by its capabilities in research and development, manufacturing, and commercialization. We look forward to deepening our cooperation with Genetron in the future to jointly fulfill our mission of improving health in China and around the world.”
Mr. Tony Acciarito, President of Thermo Fisher Scientific China
Mr. Wang Sizhen, Co-founder and CEO of Genetron Holdings Limited, stated, “Since its inception, Genetron has consistently upheld the belief of ‘Explore, Apply, Transform’ and remained committed to its original mission of advancing precision medicine in China. With the joint support from the government, clinical communities, and Thermo Fisher Scientific, our key strategic partner, Genetron’s growth in the in vitro diagnostics (IVD) sector has been remarkable, with an increasingly clear and comprehensive strategic footprint in this field. Looking ahead, Genetron is eager to engage in sustained and in-depth collaborations with more partners to develop additional molecular diagnostic products tailored to the Chinese market on the GENETRON S5 platform. This will enable more cancer patients to benefit from technological innovations and provide strong support and momentum for the development of precision oncology in China.”
Mr. Wang Sizhen, Co-founder and CEO of Genetron Holdings Limited
The market approval of GENETRON S5 underscores the continuous progress of China’s gene sequencing industry and molecular pathology sector. Moving forward, Genetron Holdings Limited will continue to expand and refine its IVD product pipeline, promote the standardization and integration of the genetic testing industry, and bring high-performance, personalized precision medicine solutions into clinical practice. By establishing a closed-loop system for cancer precision medicine, the company aims to benefit more patients. Genetron Holdings Limited looks forward to collaborating with all stakeholders to forge ahead together!