GASTROClear

GASTROClear™ is a blood-based miRNA diagnostic assay for gastric-cancer screening, developed and owned by Singapore-headquartered Mirxes觅瑞 . It detects 12 miRNA biomarkers by qPCR from a 5 mL blood sample, with reported sensitivity of 87.5% for stage-I gastric cancer and 85–87% in asymptomatic high-risk populations . First approved by Singapore's HSA in 2019 after a 5,282-person prospective trial, it was the world's first approved blood molecular test for gastric-cancer early detection ; it later gained FDA Breakthrough Device designation in 2023 and Thai regulatory approval in 2024 . Mirxes completed a 9,472-subject registration trial in China and submitted for NMPA approval, with market launch expected in 2025 . The company, which listed on the Hong Kong Stock Exchange in May 2025, also commercializes LUNGClear™ and Fortitude™ and has positioned GASTROClear as its core product alongside a pipeline of colorectal, liver and breast-cancer tests .