Official Approval for First Fully Automated Closed Library Preparation System Independently Developed by 3D Medicines
2021-08-11
Lately, ANDiS 500, an automated amplification-based device for closed library preparation which was independently designed, developed, and registered by 3D Medicines (3DMed) was awarded Class II Medical Device Registration Certificate. This marked the first fully automated closed library preparation device to be certified in China, with the following intended purpose: to complete the preparation of gene sequencing libraries when used in combination with appropriate reagents . Today, with broader and more in-depth clinical application of high-throughput sequencing, the official approval of ANDiS 500 marks a milestone for the standardization, specialization, and automation of this technology.
Registration details for ANDiS 500 fully automated closed library preparation device
Traditional library construction vs. Fully automated closed library construction
From its design to the control of critical performance indicators, the ANDiS 500 library preparation system addresses the various pain points and challenges faced by hospitals in high-throughput sequencing. This was made possible thanks to a thorough understanding of clinical needs. Furthermore, ANDiS 500 also plays an important role in the large-scale application of precision medicine, which benefits the majority of patients. Founder and Chairman of 3DMed, Dr. Xiong Lei pointed out that precision medicine should overcome three issues, namely testing precision, test automation, and unmanned data analysis, in order to make sure every patient benefits. This allows patients to receive precision treatment at any time and place. Smart diagnostic centers can be established using automated and smart precision testing units, as well as clinical and other diagnostic information, to provide physicians with easier access to data, thus helping them to make faster and more accurate treatment decisions.