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Ministry of Health & Welfare Notice 2010 – 83

Under article 53 term 3 of medical law and article 4 of rules for new Health Technology Assessment, the safety and effectiveness of the novel health technology (Ministry of Health & Welfare Notice 2010-64, Aug 23, 2010) has been updated as follows. Oct 11, 2010 Minister, Ministry of Health & Welfare Republic of Korea

Title
Gene expression profile test (CDH1,ID2,MMP9,TCF3) to predict prognosis of hepatocellular carcinoma. patients
Goal
OncoHepaTestⓇ is a gene expression profile test that can classify, assess, and predict the probability of tumor recurrence and death for individual hepatocellular carcinoma patients to aid patients and physicians in making informed decisions about the use of tailored treatment options.

Target patients
Hepatocellular Carcinoma patients (Hepatocellular carcinoma tissues from fine needle-biopsy or hepatic resection)
Method
Using hepatocellular carcinoma tissues obtained from fine needle-biopsy or hepatic resection, the gene expression profile for the set of specific prognostic markers (CDH1, ID2, MMP9, TCF3) is measured by quantitative real-time reverse transcription polymerase chain reaction to assess the risk of tumor recurrence and death for hepatocellular carcinoma patients ※Treatment decisions will be tailored to your risk group.
Safety & effectiveness
  • Gene expression profile test (CDH1,ID2,MMP9,TCF3) to predict prognosis of hepatocellular carcinoma patients is a type of in vitro diagnostic multivariate index assays that ensures safety to patients after initial sample procurement.
  • Gene expression profile test (CDH1,ID2,MMP9,TCF3) to predict prognosis of hepatocellular carcinoma patients has been assessed to provide enough evidence for its safety and effectiveness.

CERTIFICATION

TYPE YEAR TITLE
(NOTICE or APPROVAL NO.)
CERTIFICATION
INSTITUTION
NEW HEALTH TECHNOLOGY  2010 GENE EXPRESSION PROFILE TEST (CDH1, ID2, MMP9, TCF3) TO PREDICT PROGNOSIS OF HEPATOCELLULAR CARCINOMA (2010-83)  KOREA MINISTRY OF HEALTH & WELFARE 
IN VITRO DIATNOSTICS (IVD) CLASS Ⅲ  2013 ONCOHEPATEST-Q KOREA FDA 
IN VITRO DIATNOSTICS (IVD) CLASS Ⅲ  2013 ONCOHEPATEST-CDx  KOREA FDA
INVESTIGATIONAL NEW DRUG (IND) APPROVAL  2014 The Single-arm, Biomarker stratified, Prospective, Double-blinded, Multicenter Clinical Trial to Assess the Efficacy and the Safety of Combination Therapy of Hepatic Arterial Infusion of Cisplatin and 5-fluorouracil in Advanced Hepatocellular Carcinoma with Low Expression of HMGB2 Biomarker  KOREA FDA