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.
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. GASTROClear is NOT intended as a replacement for gastroscopy; it should be used in conjunction with gastroscopy and other test methods in accordance with recognised clinical guidelines. It is thus an adjective tool to aid in the detection of gastric cancer.
As such, only patients who met certain criteria are tested using GASTROClear. The result obtained from the test may indicate the presence of gastric cancer and the patient then goes for gastroscopy and biopsy as required. The output of the GASTROClear test is a risk score where a high score may indicate the presence of gastric cancer and should be followed up by gastroscopy.
|Product||Pack Size||Contents||Catalogue No.|
|Fortitude Kit 3.0||200 reactions/kit||Primers-Probes Mix, Reverse Transcriptase, Universal Probes Reaction Mix, Positive Control, Negative Control||FGS0025-1 (CE-IVD), FGS0025R (RUO)|