Roche Diagnostics Receives NMPA Approval for Ionify Vitamin D Test Kit
Roche Diagnostics announced that its Ionify® 25-Hydroxy Vitamin D Assay based on liquid chromatography-tandem mass spectrometry (LC-MS/MS) has received approval from China’s National Medical Products Administration (NMPA).The assay represents the first approved testing application for Roche’s fully automated cobas® pro i 601 LC-MS/MS system in China. The approval marks a significant milestone in bringing mass spectrometry-based vitamin D testing into routine clinical practice and advancing the broader adoption of standardized and automated mass spectrometry technologies in clinical laboratories.
Roche is also conducting additional multicenter clinical studies led by Professor Wei Guo of Zhongshan Hospital, Fudan University, in collaboration with Professor Min Li of Renji Hospital, Shanghai Jiao Tong University School of Medicine, and Professor Li Jiang of Sichuan Provincial People’s Hospital. These studies aim to expand the testing menu of the cobas pro i 601 platform to include steroid hormones, therapeutic drug monitoring, and other applications.
Mindray and Boxin Technology Join Forces to Advance Lab Auto
Mindray and Hangzhou Boxin Technology Co., Ltd. have signed a strategic cooperation agreement at Mindray’s headquarters in Shenzhen, aiming to jointly build a fully automated and intelligent laboratory ecosystem. The partnership seeks to address critical workflow bottlenecks in clinical laboratories by establishing a seamless physical automation chain spanning from blood collection to specimen disposal, enabling a closed-loop laboratory process.
Mindray will contribute its extensive expertise in hematology, clinical chemistry, immunoassay diagnostics, and deep understanding of China’s laboratory standards, while Boxin Technology will leverage its innovations in specimen collection, transportation, pre-analytical processing, and post-analytical storage solutions.
Burning Rock and Myriad Expand Global Strategic Partnership in HRD Testing
Burning Rock (NASDAQ: BNR) announced a new global technology licensing agreement with Myriad Genetics, Inc. (NASDAQ: MYGN), further strengthening their strategic collaboration in homologous recombination deficiency (HRD) testing. The upgraded myChoice HRD Plus assay will expand its testing capabilities by incorporating a new prostate Genomic Instability Score (prGIS) algorithm while maintaining the existing Genomic Instability Score (GIS) used for HRD assessment.
The companies expect the enhanced solutions to provide pharmaceutical partners worldwide with more efficient and flexible companion diagnostic (CDx) options, supporting oncology drug development and commercialization while enabling broader access to precision oncology therapies guided by molecular profiling.
Sansure Biotech Launches GAS Nucleic Acid Test
Sansure Biotech announced that its Group A Streptococcus (GAS) Nucleic Acid Detection Kit (PCR Fluorescence Probe Method) has received registration approval from China’s National Medical Products Administration (NMPA). The approval further strengthens Sansure’s respiratory pathogen testing portfolio and enhances its capabilities in rapid and precise pathogen detection. The assay is designed to support the diagnosis of GAS-associated infections, including pharyngitis and tonsillitis in both pediatric and adult patients.
According to the company, the assay offers three key advantages: high analytical sensitivity and specificity for accurate GAS detection, a rapid turnaround time of approximately 30 minutes suitable for emergency and outpatient settings, and a simplified workflow enabled by a ready-to-use, pre-mixed reagent format that reduces operational complexity and minimizes manual error.The launch reinforces Sansure’s commitment to expanding its molecular diagnostics portfolio for infectious disease testing.
Leadman Completes Acquisition of 61.5% Stake in Xiansheng Xiangrui
Leadman Biochemistry announced the completion of its acquisition of a 61.5% equity stake in Beijing Xiansheng Xiangrui Biological Products Co., Ltd., marking the successful implementation of a major asset restructuring transaction valued at approximately RMB 1.393 billion. The acquisition enables Leadman to expand beyond its core in vitro diagnostics (IVD) business and enter the specialized tuberculosis diagnostics market, creating a more diversified portfolio that combines routine diagnostics with specialty diagnostic solutions.
Leadman’s established hospital laboratory customer base is expected to complement Xiansheng Xiangrui’s extensive network across China’s Centers for Disease Control and Prevention (CDC) system, as well as clinical departments specializing in tuberculosis, respiratory diseases, and infectious diseases.
The transaction also creates opportunities for technology synergies. While Xiansheng Xiangrui’s current interferon-gamma release assay (IGRA) products are based on ELISA technology, Leadman’s expertise in chemiluminescence platforms is expected to accelerate the development of next-generation chemiluminescent IGRA solutions.The company believes the acquisition will strengthen its presence in public health and specialty diagnostic markets while supporting long-term business growth.
