Core Viewpoint - Berry Genomics (000710) has 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, marking a significant milestone in the clinical application of third-generation sequencing technology [1] Group 1 - The gene testing kit utilizes single-molecule sequencing technology for the qualitative detection of thalassemia gene mutations in human peripheral venous whole blood samples [1] - The certification of the testing kit represents a critical breakthrough in both technology and strategy for Berry Genomics, facilitating the clinical transformation of its third-generation sequencing technology [1]

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]

Core Viewpoint - Berry Genomics (000710.SZ) announced that its wholly-owned subsidiary, Hangzhou Berry Health and Technology Co., Ltd., has received a medical device registration certificate from the National Medical Products Administration for its α and β thalassemia gene testing kit, marking a significant breakthrough in the clinical application of third-generation sequencing technology [1] Group 1 - The gene testing kit utilizes single-molecule sequencing to qualitatively detect mutations in thalassemia genes from human peripheral venous whole blood samples [1] - The kit specifically identifies four deletions and three point mutations in the α-globin gene, as well as sixteen point mutations in the β-globin gene [1] - The acquisition of the registration certificate enhances the systematic layout of the company's "research - hardware - product" strategy, laying a product foundation for establishing a "Chinese solution" for third-generation sequencing [1]