DiaCarta's QClamp® KRAS Codon Specific Mutation Detection kit is a polymerase chain reaction (PCR)-based assay that uses XNA probes to suppress amplification of WT-DNA, selectively amplifying mutant DNAs

The testing procedure involves four (4) simple steps:1. Isolation of DNA from tumor biopsies, paraffin-embedded sections (FFPE), fresh frozen tumors, or tumor cell lines2. Amplification of mutant all DNAs at specified codons within the KRAS gene 3. Detection of amplification signal using a real-time PCR instrument capable of SYBR green detection 4. Documentation and interpretation of results. This test can be completed in approximately 2-3 hours from DNA to test result.Limit of Detection <0.1% RUO, <1% CE-IVD. Includes WT and Positive Controls. 6 reactions per sample. Minimal sample input (5-10ng per reaction)

The KRAS protein is a small GTPase and plays a key role 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 affects multiple fundamental cellular processes, including proliferation, apoptosis, and differentiation.

KRAS mutations are particularly common in colon cancer, lung cancer, and pancreatic cancer. 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 KRAS gene mutation status of colorectal cancer patients is relevant to drug resistance of targeted medicines such as tyrosine kinase inhibitors. Patients with wild-type KRAS gene are much more likely to benefit from the Erbitux (Cetuximab) or Vectibix (Panitumumab), compared to patients with a mutant KRAS gene.

The assay identifies the presence of all mutations in and near KRAS Codon 12 and 13 (Exon 2), Codon 61 (Exon 3) and Codons 117 and 146 (Exon 4). All mutations at a particular codon are detected, but the exact nature of the mutation is not specified.