By Fineline Cube 
Mirxes Holding Company Limited (HKG: 2629) announced that its flagship in‑vitro diagnostic (IVD) test, GASTROClear, has received formal approval from China’s National Medical Products Administration (NMPA). This marks the first blood test authorized by the NMPA for non‑invasive gastric‑cancer screening, positioning Mirxes at the forefront of early detection technology in one of the world’s largest markets.
Regulatory Achievement
- NMPA Approval – GASTROClear is now cleared for use across mainland China, expanding its commercial reach to a market of 1.4 billion potential patients.
- First‑in‑Class – The product is the first NMPA‑approved blood test for gastric‑cancer screening, a milestone that could reshape diagnostic pathways.
Product Innovation
- miRNA‑Based Detection – GASTROClear evaluates 12 gastric‑cancer‑associated microRNA (miRNA) biomarkers, offering a highly specific risk assessment without the need for invasive biopsies.
- Global Credentials – The test received earlier approval in Singapore (2019) and was designated a Breakthrough Device by the U.S. Food and Drug Administration (FDA) in 2023, underscoring its clinical value.
Market Impact
- Early Detection Advantage – By enabling earlier diagnosis, GASTROClear can improve patient outcomes and reduce treatment costs, addressing a critical unmet need in oncology.
- Competitive Edge – The NMPA clearance positions Mirxes ahead of domestic competitors and establishes a strong foothold in China’s rapidly expanding IVD sector.
Strategic Outlook
- Growth Opportunities – With regulatory clearance, Mirxes can accelerate commercialization, form strategic alliances with hospitals, and expand into other Asian markets.
- Investment Appeal – The approval enhances Mirxes’ valuation prospects, potentially attracting additional capital for research and development.-Fineline Info & Tech