Workflow
微小核酸血液检测
icon
Search documents
MIRXES-B(02629):GASTROClear?获批中国国家药监局胃癌筛查IVD注册证
Zhi Tong Cai Jing· 2025-10-08 22:34
Core Insights - MIRXES-B's core product GASTROClear has received approval from the National Medical Products Administration of China for use as a non-invasive gastric cancer screening IVD product, marking a significant milestone in the company's journey from research and development to commercialization [1] - GASTROClear is the first blood test approved for gastric cancer screening in China, utilizing a microRNA-based method to assess gastric cancer risk by detecting 12 gastric cancer-related miRNA biomarkers [1] Group 1 - GASTROClear is designated for screening high-risk adults aged 45-74 as defined by the "Guidelines for Screening and Early Diagnosis and Treatment of Gastric Cancer in China (2024 Edition)," potentially covering over 500 million individuals [2] - The product will be implemented in both public and private medical institutions in China as an IVD testing project, significantly expanding the company's business space in the gastric cancer screening market [2] Group 2 - The company plans to continue increasing its commercialization efforts in China, including expanding the sales team and upgrading local production capabilities [2] - There will be a focus on strengthening business development and collaboration in mainland China to promote broader adoption of the product [2]
MIRXES-B(02629):GASTROClear™获批中国国家药监局胃癌筛查IVD注册证
智通财经网· 2025-10-08 22:28
Core Insights - MIRXES-B's core product GASTROClear™ has received approval from the National Medical Products Administration of China for Class III medical device registration, marking it as the first blood test approved for non-invasive gastric cancer screening in China [1] - GASTROClear™ is the world's first microRNA blood test approved for early detection of gastric cancer, assessing cancer risk by detecting 12 gastric cancer-related miRNA biomarkers [1] - The approval allows GASTROClear™ to be used for screening high-risk adults aged 45-74, potentially covering over 500 million people in China [1] Company Strategy - The company plans to continue expanding its commercialization efforts in China, including increasing the size of its sales team and upgrading local production capabilities [2] - The company aims to strengthen its business development and collaboration efforts in mainland China to promote wider adoption of its products [2]