IVD China last week: DIAN, Sansure, AmoyDx, Zybio

DIAN Diagnostics’ In-House R&D Solid Tumor Large Panel Receives Full Marks in EMQN EQA

The European Molecular Genetics Quality Network (EMQN) released the results of its ONCOGENE PANEL external quality assessment (EQA). DIAN Diagnostics’ Clinical Genomics Center participated in the assessment with its independently developed solid tumor large panel and achieved a perfect score.

EMQN is an internationally recognized authority in external quality assessment for molecular genetic diagnostics. Its evaluations comprehensively reflect a laboratory’s analytical accuracy, quality management systems, and professional service capability, and are widely regarded as one of the highest global benchmarks for clinical molecular genetics laboratories. In this assessment, the genotyping results obtained by DIAN Diagnostics were fully consistent with the expected reference results, achieving full marks across all evaluated items. The self-developed solid tumor large panel by DIAN Diagnostics provides comprehensive clinical services including targeted therapy guidance, molecular subtyping, prognostic assessment, auxiliary diagnosis, chemotherapy regimen optimization, immunotherapy efficacy prediction, and hereditary cancer risk evaluation. The platform supports precision oncology by enabling personalized and accurate clinical decision-making.

Sansure Biotech and BeiGene Bio-Island Innovation Center Accelerate Integrated “Diagnosis–Therapy” Strategy

Sansure Biotech Co., Ltd. and BeiGene (Guangzhou) Innovation Technology Co., Ltd. have officially signed a strategic cooperation agreement in Beijing, marking a significant acceleration of Sansure’s “diagnosis–therapy integration” strategy. 

The collaboration will focus on clinically urgent therapeutic areas, including infectious diseases, metabolic disorders, immune and inflammatory diseases, and pediatric health. By integrating their respective strengths in technological innovation, clinical resources, commercialization capabilities, and ecosystem investment funds, the two parties aim to achieve complementary advantages and synergistic growth, ultimately delivering more precise, accessible, and comprehensive healthcare solutions for patients worldwide. In the future, the partnership will closely align with clinical needs and industry trends, embedding diagnostic technologies deeply into the full continuum of drug development—from target discovery and preclinical research to clinical trials. 

AmoyDx’s Companion Diagnostic for Capmatinib Approved by China’s NMPA

On December 11, 2025, AmoyDx, a leading company in oncology companion diagnostics, announced that its MET exon 14 skipping mutation companion diagnostic, developed for Tabrecta® (capmatinib hydrochloride tablets), has received approval from the National Medical Products Administration (NMPA) of China. The approval is based on AmoyDx’s independently developed AmoyDx® (Lung Cancer PCR – 11 Genes) assay, which was used in the pivotal clinical studies of Novartis’ capmatinib. This companion diagnostic provides a new precision treatment option for patients with MET exon 14 skipping mutation–positive non-small cell lung cancer (NSCLC).

AmoyDx® has obtained regulatory approval in China, Japan, and Europe. A total of seven genes has been approved as companion diagnostics, supporting clinical decision-making for up to 22 targeted therapies and benefiting a broad population of NSCLC patients worldwide.

Sansure Biotech’s Fully Automated Molecular Diagnostic Workflow Enters the International Market 

Recently, Sansure Biotech’s fully automated nucleic acid processing system, Natch CS3 Plus, successfully completed conformity assessment under the EU In Vitro Diagnostic Regulation (IVDR) and has officially obtained market access in the European Union.

As Sansure’s first fully automated molecular diagnostic workstation designed for international markets, the system enables complete automation from sample to result. Its integrated workflow covers tube decapping, liquid handling, nucleic acid extraction, PCR reaction setup, sealing and amplification, and result analysis, ensuring seamless and efficient operation throughout the entire testing process.

With a compact footprint of only 1.2 m², the system is space-efficient and highly flexible, making it suitable for deployment in laboratories, hospitals, and diagnostic centers across diverse professional settings. The acquisition of CE IVDR certification represents a key milestone in Sansure Biotech’s internationalization and standardization journey in molecular diagnostics.

Zybio’s Rivaroxaban Assay Kit Approved

The rivaroxaban assay kit (chromogenic substrate method), independently developed by Zybio, has been successfully included in the Chongqing Innovative Medical Device Approval Program and was officially approved for market launch by the Chongqing Municipal Medical Products Administration in June 2025.

The product is the first domestically developed direct oral anticoagulant (DOAC) concentration assay based on the chromogenic substrate method in China. Its approval fills a critical technological gap in locally manufactured quantitative DOAC testing and provides an innovative solution for precision anticoagulation therapy in clinical practice.