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三代基因测序仪SequelII CNDx
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贝瑞基因子公司三代基因测序仪SequelII CNDx获得医疗器械注册证
Zhi Tong Cai Jing· 2025-10-31 11:04
Core Insights - Berry Genomics (000710.SZ) announced that its subsidiary, Hangzhou Berry Health and Technology Co., Ltd., has received the medical device registration certificate from the National Medical Products Administration (NMPA) for its third-generation sequencing instrument, Sequel II CNDx, marking it as the first clinically approved third-generation sequencing platform globally [1][2] Group 1: Product Approval and Features - The Sequel II CNDx is the first third-generation sequencing platform approved for clinical use, enabling rapid implementation of third-generation sequencing solutions in local laboratories [1] - The approval allows for "one machine, multiple uses" and "mixed loading," which reduces sample waiting times, accelerates report cycles, and enhances service quality within hospitals [1] Group 2: Clinical Applications and Impact - The clinical approval of Sequel II CNDx will enhance the birth defect prevention system and significantly improve 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 major public health initiatives, such as the prevention of birth defects, both in China and globally [2]