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December 2, 2019

Genetron Health gets regulatory approval in China for NGS system

China-based precision oncology company Genetron Health has secured regulatory approval from the National Medical Products Administration (NMPA) of China for its semiconductor-based next-generation sequencing (NGS) system, GENETRON S5.

China-based precision oncology company Genetron Health has secured regulatory approval from the National Medical Products Administration (NMPA) of China for its semiconductor-based next-generation sequencing (NGS) system, GENETRON S5.

GENETRON S5 is a sequencing system that can identify pH value alterations in nucleotides. As it does not need fluorescence or camera scanning, it allows quicker, simpler and more cost-effective tests with smaller sample size.

Through high-speed semiconductor sequencing technology, the desktop medium-throughput semiconductor-based NGS system can produce high-quality sequencing data to aid laboratory technicians to move from DNA library to data within a timeframe of 24 hours.

The NGS System comes from the proprietary One-Step Seq Method, which helps to prepare quality libraries from input samples of just 10ng within 1.5 hours.

Genetron Health co-founder and CEO Sizhen Wang 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.”

According to the company, the technology can be applied alongside early screening, diagnosis, treatment guidance and continuous monitoring. The firm has developed diagnostic assays, which can identify lung cancer, urothelial cancer, breast cancer, gliomas and thyroid cancer.

Wang said: “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 organisations to help many more cancer patients.”

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