贝瑞基因(000710.SZ)：子公司基于三代基因测序技术的检测试剂盒获得医疗器械注册证

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 α and β-thalassemia gene testing kit using single-molecule sequencing technology, marking a significant milestone in the clinical application of third-generation sequencing technology [1] Group 1 - The testing kit represents a critical breakthrough in technology and strategy for Berry Genomics, facilitating the transition from gene testing services to a high-value model that integrates "equipment + reagents + intelligent analysis" [1] - The kit utilizes CATSA technology and single-molecule real-time (SMRT) high accuracy (HiFi) mode to achieve "one-step" detection of all mutation types of α and β-thalassemia, addressing traditional testing limitations and detection gaps [1] - The AI data analysis platform, validated by 300,000 samples, completes the "testing technology - data processing - clinical report" closed loop, enhancing the overall efficiency and reliability of the testing process [1] Group 2 - The successful registration of the testing kit strengthens the systematic layout of "research - hardware - products," accelerating the company's strategic upgrade and laying a solid product foundation for establishing a "Chinese solution" for third-generation sequencing [1]