Three patents related to the Assay have been registered in South Korea: “Novel system for predicting prognosis of locally advanced gastric cancer,” “Novel system for predicting prognosis of gastric cancer,” and “Method for manufacturing gastric cancer prognosis prediction model.” In addition, two patents are pending: “Novel system for predicting post-operative prognosis or chemotherapy benefit of advanced gastric cancer patients” and “Novel system for clustering based on the biological features of gastric cancer and predicting prognosis.” The three patents registered in South Korea are pending in some countries such as the United States of America, Europe, China, and Japan and have been registered in some other countries. Upon the registration of the two patents pending in South Korea, their patent applications will be filed through PCT in 43 countries with a high gastric cancer.
nProfiler® 1 Stomach Cancer Assay has been licensed by the Ministry of Food and Drug Safety (MFDS) with two clinical trials including exploratory clinical trial and confirmatory clinical trial, and after surgery prognosis in gastric cancer and predictive chemotherapy benefit have been validated the clinical utility of the single patient classifier algorithm with reliable gastric cancer CLASSIC TRIAL samples. An academic paper on the aforementioned study was published in THE LANCET Oncology, a foreign clinical medical journal (Volume 19, No 5, p629–638, May 2018).
More detailed information about the clinical trials can be seen at http://www.novomics.com/eng/Research/stomach.asp
Currently, the direction for the post-operative treatment of gastric cancer is determined basically by the TNM Stage Classification. However, the prognosis of gastric cancer patients with the same stage may be different.
The 5-year overall survival rates after surgery and molecular biological features of gastric cancer obtained by nProfiler® 1 Stomach Cancer Assay help clinicians to decide regarding guidelines for the treatment of each patient.
nProfiler® 1 Stomach Cancer Assay report provides patients with stage II or III advanced gastric cancer with the prognostic information about 5-year overall survival rates after surgery in the form of Prognostic Clusters.
The patients are classified into three Prognostic Clusters according to the expression levels of the genes, and the 5-year overall survival rates with CI (Confidence Interval) of the Clusters are as follows:
1) Low Risk (Prognostic Cluster Ⅰ): 82% (95% CI: 74.1–90.7%)
2) Intermediate Risk (Prognostic Cluster Ⅱ): 66.2% (95% CI: 60.6–72.3%)
3) High Risk (Prognostic Cluster Ⅲ): 55.7% (95% CI: 50.5–61.5%)
For discovery of target genes for gastric cancer prognosis, unsupervised clustering and supervised analysis have been performed. The candidate genes have been identified by Non-negative Matrix Factorization (NMF) and Weighted Correlation Network Analysis (WGCNA), which classify them into subtypes and gene-modules, and correlation analysis.
On the basis of three features related to the prognosis, the genes whose expression levels can be stably measured in heterogenetic gastric cancer tissues have been selected, and finally the four target genes with the largest range of expression levels have been determined by dynamic range analysis.
More detailed information about the gene discovery process can be seen at http://www.novomics.com/eng/Professionals/background.asp
1) Adaptive Regression Algorithm
On the basis of the critical ΔCq values affected by the expression levels of the genes, the low expression or high expression of a gene in question is determined.
2) Binary Signal-Based Two-Tier System
In the algorithm for classification of gastric cancer prognosis, the patients with high expressed immune-regulating genes were classified into low-risk (Prognostic Cluster I), and others are into intermediate-risk (Prognostic Cluster II) and high-risk (Prognostic Cluster III) in accordance with the expression levels of metastasis-regulating genes.
More detailed information about the algorithm can be seen at http://www.novomics.com/eng/Professionals/algorithm.asp
nProfiler® 1 Stomach Cancer Assay analyzes four target genes, including WARS, GZMB, CDX1, and SFRP4, and five reference genes, including ACTB, ATP5E, HPRT1, GPX1, and UBB.
The Kit works by measuring the expression levels of the gastric cancer-related genes in real time.
The expression levels of the nine genes are quantified with RT-PCR by analyzing the cDNA made by the revers tran s c r i p tion of the total RNA2) extracted from the resected tissues of patients with gastric cancer. The resultant value for each gene is plugged into the algorithm to be categorized into one of the Prognostic Clusters.
2) Total RNA: intracellular ribosomal RNA (rRNA), transfer RNA (tRNA), and messenger RNA (mRNA)
nProfiler® 1 Stomach Cancer Assay Kit is composed of Kit A and Kit B; the former contains 14 reagents and the latter has 1 for in-vitro diagnosis. The reagents are those for the measurement of the expression levels of the nine genes and the RT-qPCR test and positive and negative controls.
More detailed information about the composition of the Kit can be seen at http://www.novomics.com/eng/Professionals/product.asp
nProfiler® 1 Stomach Cancer Assay is performed as follows:
1. Curative Resection of Gastric Cancer tissue
2. Preparation of Formalin-Fixed Paraffin-Embedded (FFPE) Samples
3. Collection of Cancer Tissues (Containing 50% or more Tumor cell)
4. Measurement of Gene Expression Level
5. Clustering with nDx 1 (Algorithm Software)
6. Decision Regarding Patient’s Treatment Options.
More detailed information about each step can be seen at http://www.novomics.com/eng/Patients/diagnosis.asp
The procedure takes about two weeks from the request, including collection of gastric cancer tissues, gene analysis, and notification of the result report.
nProfiler® 1 Stomach Cancer Assay is for after surgery patients with stage II or III (AJCC 6th ed.) advanced gastric cancer.
nProfiler® 1 Stomach Cancer Assay is an in-vitro diagnostic test that measures the expression levels of nine genes, including WARS, GZMB, CDX1, SFRP4, ACTB, ATP5E, HPRT1, GPX1, and UBB, from the resected tissues of patients with stage II or III advanced gastric cancer using RT-qPCR1) and provides patients with prognostic information about 5-year overall survival rates by applying an algorithm to the measured data.
1) RT-qPCR: Real Time-quantitative Polymerase Chain Reaction, a technique used to amplify a DNA or RNA segment in real time
- Use of nDx 1 Software is only available to partners who are registered separately in Novomics.
- You must pass the certification procedure on the next screen before you can use the software.
- Click the "Certification" button to install it automatically on your connection PC.
If you do not want to install, click the "Close Screen" button.
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