贝瑞基因子公司三代基因测序仪Sequel®II CNDx获得医疗器械注册证

Group 1 - Berry Genomics' subsidiary, Hangzhou Berry Genomics and Health Technology Co., Ltd., has received the NMPA medical device registration certificate for its third-generation sequencing instrument, Sequel® II CNDx, making it the first clinically approved third-generation sequencing platform globally [1] - The approval of Sequel® II CNDx enables rapid implementation of third-generation sequencing solutions in local clinical laboratories, reducing sample waiting times, accelerating report cycles, and enhancing service quality within hospitals [1] - Berry Genomics has achieved full self-production of third-generation sequencing testing reagents and the local deployment of an intelligent report interpretation system, providing comprehensive localized services from sample collection to report management [1] Group 2 - The clinical approval of Sequel® II CNDx enhances the birth defect prevention system and significantly improves the detection capabilities for complex single-gene diseases [2] - Berry Genomics aims to deepen the clinical application of third-generation sequencing technology by optimizing AI algorithms and local deployment plans, making testing services more precise, efficient, and economical for families [2] - The large-scale application of third-generation sequencing technology is expected to accelerate the advancement of major public health projects, such as birth defect prevention, both in China and globally [2]