The GASTROClear, an in-vitro diagnostic medical device (IVD), is intended for use as an adjunctive test for the detection of gastric neoplasia associated miRNA biomarkers in human serum. The test measures a panel of 12 microRNA biomarkers which has been shown to detect 87% of all gastric cancers, including up to 89% of early-stage (stage 1-2) gastric cancers.. The expression levels of these 12 microRNAs are translated into a risk score calculated by a clinically validated proprietary algorithm. Based on risk scores, patients are classified as high risk, intermediate risk, or low risk, with specific follow-up recommendations for doctors in managing each group.