MIRXES-B (02629) announced that its core product GASTROClear™ has received Class III medical device registration approval from China's National Medical Products Administration (NMPA) as an in vitro diagnostic (IVD) product for non-invasive gastric cancer screening in China. This product marks the first blood-based test approved by the NMPA for gastric cancer screening.

GASTROClear™ represents the world's first approved microRNA (miRNA) blood test for early gastric cancer detection, utilizing 12 gastric cancer-related miRNA biomarkers to assess gastric cancer risk. The product previously received approval in Singapore in 2019 and was granted FDA Breakthrough Device Designation in the United States in 2023.

This NMPA approval in China signifies a crucial milestone in the company's journey from research and development to commercialization, reflecting the results of its technological innovation and large-scale clinical trials, built upon long-term commitment and investment in innovation and market access.

According to the approved intended use, GASTROClear™ can be utilized for screening high-risk adults aged 45-74 as defined in the "Guidelines for Gastric Cancer Screening, Early Diagnosis and Treatment in China (2024 Edition)," potentially covering a population of over 500 million people.

The product will be deployed as an IVD testing service in both public and private medical institutions across China, significantly expanding the company's business scope in China's gastric cancer screening market. Moving forward, the company plans to continue increasing its commercial investment in China, including expanding its sales team and upgrading local production capabilities. Additionally, the company will further strengthen its business development and partnership initiatives in mainland China to promote broader product adoption.