Amoy Diagnostics Co.,Ltd.

Detection of 17 KRAS mutations (exons 2, 3 and 4), 13 NRAS mutations (exons 2, 3 and 4) and six BRAF V600 mutations (exon 15)

KRAS, NRAS and BRAF genes are the key molecules in the downstream signaling pathway of epidermal growth factor receptor (EGFR). These pathways control cell proliferation,differentiation and apoptosis.Frequency of KRAS, NRAS and BRAF mutations in colorectal cancer are36~40%, 1~6% and 8~15% respectively. Most frequent mutations occur in exons 2, 3 and 4 of RAS gene, and in codon 600 of BRAF gene.

KRAS mutations and NRAS mutations predict a lack of response to cetuximab (Erbitux®) and panitumumab (Vectibix®) therapy in colorectal cancer (CRC).^[1]A number oflarge studies^[2][3] have shown that cetuximab has significant efficacy in mCRCpatients with RAS wild-type tumors.And mutations in BRAF gene are a strong prognostic marker. Clinical data has shown that colorectal cancer patients with mutant BRAF gene are less likely to response to EGFR-TKIs therapy. NCCN Clinical Practice Guideline for colon cancer clearly indicates that all patients with metastatic colorectal cancer should be determined of tumor RAS (KRAS/NRAS) and BRAF genes status.

The AmoyDx®KRAS/NRAS/BRAFMutationsDetection Kit is a real-time PCR test intended for qualitative detection of 17 KRASmutations(exons 2, 3 and 4),13 NRASmutations(exons 2, 3 and 4)and six BRAF V600mutations(exon 15).

References:

1) Lièvre et al. (2006). Cancer Res. 66 (8): 3992–5.

2) Bokemeyer et al, (2009). J. Clin. Oncol. 27 (5): 663–71.

3) Van Cutsem et al. (2009). N. Engl. J. Med. 360 (14): 1408–17.

4) NCCN Clinical Practice Guidelines inOncology™, Colon cancer. V1.2015

Intended Use

CE marked for IVD use in Europe.

Technological Principles

The kit uses novel, patented primers and probes to detect mutations in a real-time PCR assay. 

The mutant DNA is amplified accurately by the specific primers, and detected by the novel probes. 

Highly Specific primers and probes, and a highly validated procedure based on Taq DNA 

polymerase contribute to outstanding assay sensitivity and selectivity.

17 KRAS, 13 NRAS and 6 BRAF mutations detected by the panel: