Mirxes has received regulatory approval from China’s National Medical Products Administration (NMPA) for GASTROClear, a blood-based diagnostic test. The approval allows for gastric cancer screening among high-risk adults aged 45 to 74 within the Chinese market.
- Clinical Data: The test identifies 12 microRNA markers and demonstrated an 87.5% sensitivity rate for stage 1 gastric cancer during a clinical trial of 9,472 subjects conducted between 2021 and 2023.
- Market Expansion: Following regulatory clearance, the company plans to triple its Chinese sales team by 2026 and upgrade manufacturing facilities to supply public and private health institutions.
- Clinical Application: The non-invasive test serves as a screening alternative to gastroscopy for an eligible population estimated at 500 million people under current national health guidelines.
This summary is based on a press release issued by Mirxes.