Mirxes' GASTROClear Becomes First NMPA-Approved Blood Test for Gastric Cancer Screening in China
核心洞察
Mirxes (搜索)' GASTROClear (搜索) has received China's National Medical Products Administration approval as the first blood test for gastric cancer screening, marking a significant regulatory milestone.
The microRNA (搜索)-based diagnostic targets high-risk adults aged 45-74, representing a potential population exceeding 500 million people in China.
GASTROClear (搜索) previously gained approval in Singapore in 2019 and received FDA Breakthrough Device designation in 2023, demonstrating global regulatory recognition.
Mirxes (搜索) Holding Company Limited announced that its core product, GASTROClear (搜索), has received approval from China's National Medical Products Administration (NMPA) for a Class III medical device registration certificate as an in vitro diagnostic (IVD) product for non-invasive gastric cancer screening. This approval represents a historic milestone as GASTROClear becomes the first blood test approved by the NMPA for gastric cancer screening in China.
World's First Approved miRNA Blood Test for Gastric Cancer
GASTROClear (搜索) is the world's first microRNA (搜索) (miRNA) blood test approved for early detection of gastric cancer. The diagnostic assesses gastric cancer risk by detecting 12 gastric cancer-related miRNA biomarkers through a simple blood draw, offering a non-invasive alternative to traditional screening methods.
The product has demonstrated strong regulatory validation across multiple jurisdictions. GASTROClear (搜索) was initially approved in Singapore in 2019 and subsequently received the "Breakthrough Device" designation from the U.S. Food and Drug Administration (FDA) in 2023, highlighting its innovative approach to cancer screening.
Massive Market Opportunity in China
According to the approved intended use, GASTROClear (搜索) can be used to screen high-risk adults aged 45-74 for gastric cancer as defined in the "China Gastric Cancer Screening and Early Diagnosis and Treatment Guidelines (2024 Edition)." This represents a potential target population exceeding 500 million people in China, indicating substantial market opportunity for the company.
The product will be implemented as an IVD test in both public and private medical institutions throughout China, significantly expanding Mirxes (搜索)' business opportunities in the Chinese gastric cancer screening market.
Strategic Commercialization Plans
The NMPA approval marks a significant milestone for Mirxes (搜索) in transitioning from research and development to commercialization, reflecting the company's achievements in technological innovation and large-scale clinical trials. These accomplishments are rooted in the company's long-term commitment and investment in innovation and market access.
Moving forward, Mirxes (搜索) plans to continue expanding its commercialization efforts in China through several strategic initiatives. The company will increase the size of its sales team and upgrade local production capabilities to support the rollout of GASTROClear (搜索). Additionally, Mirxes will strengthen its business development and collaboration strategy in mainland China to promote broader adoption of the product across the healthcare system.