IVD China last week: Sansure, KHB, Roche, DIAN

Sansure Biotech and Health-100 Form Strategic Partnership to Advance Quantified, Precision Health Management

On December 19, 2025, Sansure Biotech and Health-100 signed a strategic cooperation agreement in Shanghai to jointly promote a “quantified life, precision health” model. By integrating Sansure’s precision diagnostics portfolio with Health-100’s nationwide health check-up network, large-scale health data assets, and AI-driven management capabilities, the partnership aims to build a closed-loop health management system spanning screening, diagnosis, and intervention. Key initiatives include the introduction of advanced molecular and genetic testing into Health-100’s check-up services and the development of dual scenarios combining medical centers with home-based testing, marking a step toward more personalized, data-driven preventive healthcare in China.

Dian Diagnostics Delivers China’s First Healthcare Data Transaction Through a Trusted Data Space

On December 18, 2025, Hangzhou Dian Medical Laboratory Co., Ltd., a subsidiary of Dian Diagnostics, officially completed a medical data transaction with Vecverse at the Hangzhou Data Exchange, with delivery conducted through the Hangzhou City Trusted Data Space. This marks the first application of the trusted data space in the healthcare sector. The data product traded is a high-quality clinical imaging dataset designed for disease-assisted diagnosis, featuring standardized collection, processing, security compliance, and fine-grained annotation based on international classification systems. The dataset is expected to support AI model training and validation in medical imaging analysis, enabling applications such as early disease screening, diagnostic support, and progression assessment. The transaction highlights the growing role of compliant medical data circulation in advancing medical AI and smart healthcare innovation in China.

Roche Diagnostics and Ruijin Hainan Hospital Establish Pilot Center for Special-Access Diagnostic Products

Roche Diagnostics China announced a strategic collaboration with Ruijin Hospital Hainan (Boao Research-Oriented Hospital) to jointly establish a “Pilot Center for Special-Access Diagnostic Products.” This initiative marks Roche’s first China-based collaborative model dedicated to the early clinical application of special-access IVD products under the Hainan Free Trade Port framework. Leveraging Boao Lecheng’s policy advantages, the center will integrate early clinical use, real-world research, clinical translation, and academic exchange to accelerate the introduction of globally innovative diagnostic solutions into China. Since 2021, Roche has enabled 16 breakthrough diagnostic solutions to enter clinical use in Hainan, supporting faster patient access and setting a scalable “Hainan model” for IVD innovation localization.

KHB Launches Its First Class II Registered Magnetic Bead–Based LC-MS Vitamin D Assay in China

KHB announced the approval and market launch of its independently developed 25-hydroxyvitamin D LC-MS/MS assay, marking the company’s first Class II registered magnetic bead–based mass spectrometry reagent in China. The assay can accurately distinguish the isomer 3-epi-25(OH)D, improving result precision, and is compatible with KHB’s automated magnetic bead sample preparation systems to enable standardized, high-throughput workflows. Designed for clinical applications across pediatrics, endocrinology, obstetrics, orthopedics, geriatrics, and nephrology, the product supports precise assessment and management of vitamin D deficiency and excess, further expanding KHB’s precision diagnostics portfolio.