FAQ

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• What is the nProfiler® 1 Stomach Cancer Assay?

  nProfiler® 1 Stomach Cancer Assay is a molecular diagnostic test for patients who are diagnosed with stage Ⅱ and Ⅲ gastric cancer after D2 gastrectomy and enables to stratify patients into different risk parameters (Low, Intermediate, and High risk group). nProfiler® 1 Stomach Cancer Assay has been approved by MFDS as in vitro diagnostic medical device (Product License No.17-865).

   

  For more details, http://www.novomics.com/en/profiler/product.asp 

• Who is eligible for nProfiler® 1 Stomach Cancer Assay?

  Gastric cancer patients who are diagnosed with stage II and III after D2 gastrectomy are eligible for nProfiler® 1 Stomach Cancer Assay. 

• How is nProfiler® 1 Stomach Cancer Assay done and how long will it take to get the results?

   

  Service flow of nProfiler® 1 Stomach Cancer Assay

  1. Genetic Test Consent Form
  2. D2 radical gastrectomy
  3. FFPE sample preparation
  4. Obtain cancerous tissue from the FFPE sample
  5. Measurement of gene expression level
  6. Data analysis using nDx 1
  7. Test report

   

  The results of nProfiler® 1 Stomach Cancer Assay are available within 14 days from the time of ordering the test.

   

  This given period includes the full process from sample collection to report delivery.

   

  For more details, http://www.novomics.com/en/profiler/service.asp

  
  

   

• What does nProfiler® 1 Stomach Cancer Assay consist of?

  nProfiler® 1 Stomach Cancer Assay consists of Kit A and Kit B including 14 and 1 IVD reagents, respectively.

   

  These IVD reagents consist of RT-qPCR reagents (e.g. RT Mix, RT Buffer, etc), negative and positive control, and specific reagents for measurement of 9 gene expression levels. 

• How does nProfiler® 1 Stomach Cancer Assay work?

  nProfiler® 1 Stomach Cancer Assay measures and analyses the expression level of gastric cancer related genes in real-time.

   

  nProfiler® 1 Stomach Cancer Assay measures the expression level of specific genes in the extracted RNA from gastric cancer tissue after D2 gastrectomy using RT-qPCR. Then, the prognosis is predicted based on the expression level using algorithm. 

• What genes are tested in nProfiler® 1 Stomach Cancer Assay?

  nProfiler® 1 Stomach Cancer Assay measures the expression of 9 genes: 4 target genes (WARS, GZMB, CDX1, and SFRP4) and 5 reference genes (ACTB, ATP5E, HPRT1, GPX1, and UBB). 

• What are the distinctive features of algorithm?

   

  A threshold value of each gene is a reference point that distinguishes high and low expression of a corresponding gene. The prognosis and predictive classification are performed using a binary signal based two tier system based on the expression level of 4 target genes.

   

  First Tier: Classifying a group as a Low risk group and no-benefit group when ΔCq values of GZMB and WARS are higher than threshold values.

   

  Second Tier-Prognosis: At least one ΔCq value of GZMB and WARS is lower than the threshold value, classifying a group as an Intermediate risk group when the ΔCq value of SFRP4 is lower than threshold value and a group as a High risk group when the ΔCq value of SFPR4 is higher than the threshold value.

   

  Second Tier-Prediction: At least one ΔCq value of GZMB and WARS is lower than the threshold value, classifying a group as a no-benefit group when the ΔCq value of CDX1 is lower than threshold value and a group as a chemotherapy-benefit group when the ΔCq value of CDX1 is higher than the threshold value.

   

  For more details, http://www.novomics.com/en/profiler/algorithm.asp

  
  

   

• What are the characteristics of each prognosis group?

   

  nProfiler® 1 Stomach Cancer Assay classifies patients into Low risk group (IM type: high expression of immune genes), Intermediate risk group (EP type: high expression of epithelial gene and low expression of immune genes), and High risk group (ST type: high expression of stem-like gene and low expression of immune genes).

   

  Additionally, the chemotherapy benefit group are to be expected to benefit from adjuvant chemotherapy after gastrectomy as they show relatively high proliferation rate. However, in case of no-benefit group showing a low or high immune activity and low epithelial characteristics, it is hard to expect for benefits of chemotherapy.

  
  

   

• What are reported results?

  The report of nProfiler® 1 Stomach Cancer Assay provides information on 5-year overall survival for the patients with gastric cancer stage II and III after gastrectomy according to prognostic group.

   

  Patients are stratified into 3 prognostic groups based on the level of gene expression and these are the 5-year overall survival and 95% confidence interval (CI) for each group.

   

  1) Low risk group: 82% (95%CI: 74.1-90.7)

  2) Intermediate risk group: 66.2% (95%CI:60.6-72.3)

  3) High risk Group: 55.7% (95% CI: 50.5-61.5)

   

  For more details, http://novomics.com/en/profiler/interpreting.asp 

• How to use the results of nProfiler® 1 Stomach Cancer Assay?

   

  The TNM staging classification is used to guide the treatment method for gastric cancer in current clinical practice. However, the differences in biological characteristics in gastric cancer patients in the same stage would bring different results on the effect of chemotherapy. 

   

  Physicians can use the result of nProfiler® 1 Stomach Cancer Assay as supplementary information to identify treatment options in gastric cancer.

  
  

   

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