Novomics

Sofrware Information

1. Use of nDx 1 Software is only available to partners who are registered separately in Novomics.

2. You must pass the certification procedure on the next screen before you can use the software.

3. Click the "Certification" button to install it automatically on your connection PC.

S/W InstallPlease enter your
partner number and certification number
Partner No. Certification No.

* Contact us : +82-2-2068-3700

Product
Description

According to the International Agency for Research on Cancer (IARC)'s World Cancer Report 'Globocan: 2018', stomach cancer is the fifth most common cancer in the world, with 5.7% of all new cases of cancer. Korea has the highest incidence rate of stomach cancer in the world, 33.3 per 100,000 people. Unlike breast cancer and colon cancer, there is no molecular diagnostic product available for stomach cancer that enables post-operative (D2 dissection) prognosis prediction.

Novomics developed the world’s first molecular diagnostic assay, nProfiler® 1 Stomach Cancer Assay, for post-operative prediction in stomach cancer and the product approved by Ministry of Food and Drug Safety in 2017. In addition, this product was highly evaluated with its advanced technology, nominated as the First Innovative Medical Technology in 2019.

nProfiler® 1 Stomach Cancer Assay is designed to analyze the gene expression profiles (GZMB, WARS, SFRP4, CDX1) of stage II-III gastric cancer using the principle of real-time qPCR (RT-qPCR) to measure RNA quantitation and access a patient’s risk of overall survival within 5 years using a developed Single Patient Classifier algorithm.

Mechanism

The algorithm consists of Single Patient Classifier-prognosis; SPC-prognosis and Single Patient Classifier-prediction; SPC-prediction. SPC-prognosis determines the post-operative prognosis for gastric cancer into three different risk parameters, Low, Intermediate, and High risk, and SPC-prediction classifies patients into chemotherapy-benefit group and no-benefit group.

Clinically, this testing is aiming to provide important prognostic information to clinicians and ultimately it helps identifying treatment plans and/or methods, resulting in avoidance of over- or under-treatment depending on patient’s condition.

The clinical validity and utility of nProfiler® 1 Stomach Cancer Assay had been evaluated using samples archived from CLASSIC trial which is a phase 3 open-label, multi-centre, randomized controlled trial and the result was published on the Lancet Oncology (2018. Impact Factor; 35.386) in May 2018.

The results are expected to contribute optimizing the strategies of gastric cancer treatment, ultimately leading to contribute to the realization of precision medicine for every single patient.

User Manual Download

NO. Title Description
1 Product group IVD reagents for cancer related gene Kit
2 Product Name nProfiler® 1 Stomach Cancer Assay
3 Classification Number N02030.01 (Class3)
4 Candidate Advanced Gastric cancer patients with Stage II-III (AJCC 6th edition)
5 Intended Use Classify the prognosis of each patient (Low, Intermediate, High risk) using algorithm based on 9 gene expression profiles obtained from FFPE tumor cancer tissue samples using RT-qPCR
6 Package Unit Kit A, Kit B 1 set / Specimens of 15 persons
7 Storage Condition KIT A : -20℃ , KIT B : -20℃
8 Shelf Life 6 months from the date of manufacture
9 S/W nDx 1 Software