DiaCarta's QClamp® NRAS 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. 5 reactions per sample. Minimal sample input (5-10ng per reaction)

NRAS is a member of the RAS family of small GTPases and plays a central role in the MAPK signaling pathways. NRAS has been implicated in the pathogenesis of several cancers.

NRAS mutations are particularly common in melanoma, hepatocellular carcinoma, myeloid leukemias, and thyroid carcinoma. Activating mutations in codons 12, 13, and 61 have been found in various cancers, including melanoma (13-25%), colorectal cancer (1-6%), lung cancer (1%), hepatocellular carcinoma (10%), myeloid leukemias (14%), and thyroid carcinoma (7%).

Mutations in the NRAS gene have been shown to produce resistance to anti-NRAS therapeutic agents such as Cetuximab plus chemotherapy and are prognostic indicators of poor survival in patients with metastatic CRC. NRAS is also an important therapeutic target in melanoma. The recent PEAK Phase 2 clinical study of Panitumumab and Bevacvizumab plus mFOLFOX6 for first line treatment of metastatic colorectal cancer exemplified the need for extended testing of NRAS and NRAS mutations at codons 61, 117 and 146 for selection of patients that would respond to anti-NRAS antibody combination therapy.

The assay identifies the presence of all mutations in and near NRAS Codon 12 and 13 (Exon 2), Codon 61 (Exon 3) and Codon146 (Exon 4). All mutations at a particular codon are detected, but the exact nature of the mutation is not specified.