AmoyDx® KRAS Mutation Detection Kit | 8.01.20102W006/8.01.20102X024H

AmoyDx® KRAS Mutation Detection Kit | 8.01.20102W006/8.01.20102X024H | Gentaur UK, US & Europe Distribution  

KRAS protein is a GTPase and one of the key molecules in the downstream signaling pathway of epidermal growth factor receptor (EGFR). KRAS protein transduces signals from membrane-bound receptors via multiple downstream effector pathways and thereby affects fundamental cellular processes, including proliferation, apoptosis, and differentiation. In total, activating mutations in the KRAS genes occur in 15~30% of lung cancer and 20~50% of colorectal cancer, mainly in exons 2, 3 or 4. The mutation status of the KRAS gene is relevant to the primary drug resistance of colorectal cancers treated with anti-EGFR monoclonal antibodies. Patients with wild-type KRAS gene could benefit from Erbitux (Cetuximab) or Vectibix (Panitumumab), whereas, the patients with mutant KRAS gene show poor response to this treatment. The European Drug Administration Organization and US FDA approve the employment of KRAS gene mutation detection prior to the use of targeted medicines in the treatment of metastatic colorectal cancer.

Intented Use

The AmoyDx® KRAS Mutation Detection Kit is a real-time PCR assay for qualitative detection of 19 somatic mutations in codons 12, 13, 59, 61, 117 and 146 of KRAS gene in human genomic DNA extracted from formalin-fixed paraffin-embedded (FFPE) tumor tissue. The kit is intended to assess KRAS mutation status in colorectal cancer patients.

The kit is for in vitro diagnostic use, and intended to be used by trained professionals in a laboratory environment.

Testing Procedure