Genetron Health has been granted approval by China’s National Medical Products Administration (NMPA) for GENETRON S5, its semiconductor-based next-generation sequencing system (NGS system).
With the approval, the Chinese precision oncology company can launch the new desktop medium-throughput NGS system for clinical applications.
The NGS system has been developed by Genetron Health for the detection of changes in pH value in nucleotides.
The Genetron S5 NGS system is claimed to deliver fast and simple cost-effective tests with a small sample size without the use of fluorescence or camera scanning. The NGS system is designed for early screening, diagnosis, treatment guidance, and also continuous monitoring.
By utilizing high-speed semiconductor sequencing technology, the system can generate high-quality sequencing data that helps laboratory technicians to go from the DNA library to data within 24 hours.
Developed based on the company’s One-Step Seq method, the Genetron 5S NGS system enables the preparation of quality libraries within 1.5 hours from very small samples like 10ng.
Sizhen Wang – Co-founder and CEO of Genetron Health said: “The approval of GENETRON S5 provides another excellent choice for clinical laboratories and adds another powerful instrument for the standardization of molecular diagnosis.
“GENETRON S5 will deliver high-quality laboratory testing while providing data for clinical use and precision medicine in a much faster manner.”
The precision oncology company claimed that the diagnostic assays developed by it can be used for more effective detection of gliomas, urothelial cancer, lung cancer, thyroid cancer and breast cancer.
Sizhen Wang added: “Since our establishment, Genetron Health has explored new technology and areas of application while adapting to changes in the industry landscape to improve precision medicine in China.
“Working with clinical experts and our strategic partners, we have made progress in the field of in vitro diagnostic devices (IVD). The efficiency and speed of GENETRON S5 makes it possible for clinical organizations to help many more cancer patients.”