Description
The Science
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.
Benefits
Earlier detection
GASTROClear helps detect gastric cancer early, so that timely life-saving treatment can be administered.
Detects cancer before symptoms
GASTROClear is intended for use in an asymptomatic average-risk population
Detects all stages of gastric cancer
GASTROClear detects high-grade dysplasia (stage 0) and all stages of gastric cancer (from stage 1-4).
Complementary
GASTROClear testing complements H. pylori testing and gastroscopy in early detection of gastric cancer .
Blood test
GASTROClear requires only a single tube of blood which is minimally invasive.
Cost-effective screening
GASTROClear is designed to be used in conjunction with gastroscopy for cost-effective gastric cancer screening in populations with low to intermediate gastric cancer prevalence.
Intended Use
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.
Risk factors
This test is intended for adults of either sex, 40 years or older at average risk of having gastric cancer with one of the following risk factors:
- Family history of stomach cancer
- A history of Helicobacter Pylori (H. Pylori) infection.
- Long term stomach inflammation (chronic gastritis)
- Diets containing large amounts of fried food, smoked foods, salted fish, processed meat, and pickled foods.
- Diets containing nitrites and nitrates substances commonly found in cured meats.
- Diet low in fruit and vegetables.
- Smoking.
Product Description
- Contains reagents and consumables to analyze 39 patient samples
- Includes quantitative reference and negative controls
- Includes RNA extraction reagents
- Includes Gastrosmart analysis program
- 12 microRNA biomarkers measured per sample
Ordering Information
| 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) |
