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]

Core Insights - Berry Genomics' subsidiary, Hangzhou Berry Genomics, has received NMPA approval for its Sequel® II CNDx third-generation gene sequencer, marking it as the first clinically approved third-generation sequencing platform globally [1][2] - The approval allows for 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] Industry 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] - The advancement of domestic technology is expected to accelerate its global reach, with Berry Genomics aiming to optimize AI algorithms and local deployment plans to lower technical barriers [2] - The large-scale application of third-generation sequencing technology is anticipated to promote significant public health initiatives, particularly in the prevention of birth defects both in China and globally [2]

Core Viewpoint - Berry Genomics announced that its wholly-owned 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 sequencer, Sequel® II CNDx, making it the first third-generation sequencing platform approved for clinical use globally [1] Group 1 - The Sequel® II CNDx is the world's first third-generation sequencing platform approved for clinical application [1] - Berry Genomics has achieved full self-production of third-generation sequencing detection reagents and the local deployment of an intelligent report interpretation system [1]