Group 1 - The core point of the article is that Berry Genomics' subsidiary has received regulatory approval for its third-generation gene sequencer, Sequel II CNDx, marking it as the first clinically approved platform of its kind globally [1][2] - The approval allows for the rapid implementation of third-generation sequencing solutions in local clinical laboratories, enhancing service quality and reducing sample wait times [1] - Berry Genomics has achieved full local production of third-generation sequencing reagents and the 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 will improve the birth defect prevention system and enhance the detection capabilities for complex single-gene diseases [2] - The company aims to further develop the clinical applications of third-generation sequencing technology by optimizing AI algorithms and local deployment plans, making testing services more accessible and cost-effective for families [2] - The large-scale application of third-generation sequencing technology is expected to significantly advance major public health initiatives, such as the prevention of birth defects, both in China and globally [2]

Core Viewpoint - Berry Genomics (000710) announced that its wholly-owned subsidiary, Hangzhou Berry Genomics and Health Technology Co., Ltd., has recently received the medical device registration certificate from the National Medical Products Administration (NMPA) for its third-generation gene sequencer, Sequel II CNDx [1] Group 1 - The Sequel II CNDx is a third-generation gene sequencer [1] - The medical device registration certificate was issued by the National Medical Products Administration (NMPA) [1]

Core Viewpoint - Berry Genomics has announced that its subsidiary, Hangzhou Berry Genomics and Health Technology Co., Ltd., has received a medical device registration certificate from the National Medical Products Administration for its third-generation gene sequencer, Sequel II CNDx, marking it as the world's first third-generation gene sequencing platform approved for clinical use [1] Company Summary - The Sequel II CNDx is the first third-generation gene sequencing platform to be approved for clinical application globally [1] - Berry Genomics has achieved full self-production of third-generation sequencing detection reagents and has deployed an intelligent report interpretation system locally [1]