Diagnostic kit for the prediction of prognosis of stomach cancer patients was developed through approximately 6 years of research from 2010 to 2015.
We executed multiple numbers of experiments on the basis of the microarray for the screening of the target genes for prognosis if stomach cancer and used multiple numbers of proven analytic methods with high level of reliability throughout the world including Non-negative Matrix Factorization (NMF), Significance Analysis of Microarray (SAM), Prediction Analysis of Microarray (PAM) and Weighted Gene Co-expression Network Analysis (WGCNA), etc
Novomics is manufacturing and managing our products by completing the ISO 13485, an international quality standard criteria certified not only in Europe but also throughout the world and KGMP Certification of the Ministry of Food and Drug Safety of Korea, and in accordance with the quality management system of our company in order to ensure the reliability of the product quality.
GMP manufacturing room (clean room) established on the basis of the ISO 13485 standards is managed under the Class 8 (less than 100,000/ft3, 0.5㎛) and the products are protected against contaminant particles, temperature, humidity and various pathogens at the time of manufacturing of the products through regularly scheduled PQ Validation.
The final analytic performance test for prototype of Stomach Cancer IVDx manufactured in the GMP manufacturing room was completed in July 2016. Successful results were obtained in all tests on the diagnostic kit including sensitivity, specificity, reproducibility and repeatability over a period of 3 months.
Cancer IVDx has completed clinical testing of the Food and Drug Safety Department. This clinical test is aimed at the evaluation of the clinical efficacy, usefulness and safety, and is composed of 2 clinical tests, namely, explorative clinical test and confirmative clinical test.
Following the completion of the final clinical test, procedures such as the product licensing by the Ministry of Food and Drug Safety / public announcement of the new health technology assessment by the Ministry of Health and Welfare / acknowledgement of coverage for health insurance by the Health Insurance Review Agency are scheduled. It will be launched in the market after the completion of all the procedures for the approval and permit.
CLASSIC clinical test is the clinical test that discovered that auxiliary anti-cancer therapy increases the survival rate of stomach cancer patients, that is, the rate of 3-year survival without disease for the group using anti-cancer agent (74%) is 15% higher than that for the surgery only group (59%), after the D2 stomach dissection on stage 2 and 3 progressive stomach cancer patients.
With the above results of clinical test, the auxiliary anti-cancer treatment therapy following surgery in the case of the patients who are in stages higher than stage 2 in accordance with TNM clinical stage classification method has been verified and is currently acknowledged as the standard treatment method (Gold Standard).
1. Predictive test for chemotherapy response in resectable gastric cancer: a multi-cohort, retrospective analysis. January 2018 Lancet oncology
2. Adjuvant capecitabine and oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): a phase 3 open-label, randomized controlled trial. Volume 379, p315–321, January 2012 Lancet
3. Adjuvant capecitabine plus oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): 5-year follow-up of an open-label, randomized phase 3 trial. Volume 15, p1389–1396, November 2014 Lancet Oncology
- Use of nDx 1 Software is only available to partners who are registered separately in Novomics.
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- Click the "Certification" button to install it automatically on your connection PC.
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