Berry Genomics' subsidiary's third-generation gene sequencer Sequel®II CNDx has obtained a medical device registration certificate
Berry Genomics' wholly-owned subsidiary, Hangzhou Berry Health Gene Diagnostic Technology Co., Ltd., has recently obtained the medical device registration certificate from the National Medical Products Administration for its third-generation gene sequencer Sequel® II CNDx. This is the world's first third-generation gene sequencing platform approved for clinical application, capable of accelerating sample processing and reporting cycles, thereby improving in-hospital service quality. Berry Genomics has achieved independent production of third-generation sequencing supporting detection reagents, promoting domestic technological achievements to advance globally
According to the Zhitong Finance APP, Berry Genomics (000710.SZ) announced that its wholly-owned subsidiary, Hangzhou Berry Health and Technology Co., Ltd., has recently received the medical device registration certificate (Registration No.: Guo Xie Zhu Zheng 20253222085) issued by the National Medical Products Administration (NMPA) for its third-generation gene sequencer Sequel® II CNDx.
The Sequel® II CNDx is the world's first third-generation gene sequencing platform approved for clinical use. The approval of this sequencer allows third-generation sequencing solutions to be rapidly implemented in local laboratories of clinical institutions, truly achieving "multi-use" and "mixed operation," thereby reducing sample waiting times, accelerating report cycles, and improving the quality and level of in-hospital services. As of now, Berry Genomics has fully realized the independent production of third-generation sequencing supporting detection reagents and the local deployment and delivery of an intelligent report interpretation system, further providing clinical services for the entire localized construction process from sample collection and extraction, library construction, high-throughput sequencing, data analysis and interpretation to report management.
After the clinical approval of Sequel® II CNDx, it not only helps clinical practices further improve the birth defect prevention and control system and significantly enhances the detection capabilities for complex single-gene diseases but also accelerates the global advancement of domestic technological achievements. Berry Genomics will continue to deepen the clinical application of third-generation sequencing technology by optimizing AI algorithms and improving localized deployment solutions, further lowering technical barriers, allowing more families to enjoy more precise, efficient, and economical testing services. At the same time, the large-scale application of third-generation sequencing technology will strongly promote the rapid advancement of major public health projects such as birth defect prevention and control in China and globally
