Also available: KRAS/BRAF Mutation Panel

KRAS Mutations and Cancer

The KRAS gene encodes a small GTPase that plays a key role in transducing signals from the epidermal growth factor receptor (EGFR) to downstream effectors.  KRAS mutations have been commonly found in several types of human malignancies, such as colorectal cancer¹, lung adenocarcinoma² and thyroid cancer.³  The most common mutations are found in codons 12, 13 and 61. Approximately 40% of colorectal and 25% of lung tumors carry these mutations.^1,2

Recent studies have demonstrated that tumor cells carrying any of these mutant forms of the KRAS gene are less likely to respond to anti-EGFR antibody therapy.⁴  The American Society of Clinical Oncology (ASCO) recently released its first Provisional Clinical Opinion (PCO) suggesting that all patients to be administered anti-EGFR monoclonal antibody therapy (e.g. cetuximab, panitumumab and erlotnib) should be screened for KRAS mutations.⁵

Testing Procedure and Analysis
EntroGen’s KRAS mutation screen is a polymerase chain reaction (PCR)-based assay and uses allele-specific probes to identify the presence of mutations in codons 12, 13 and 61.  The testing procedure involves four (4) simple steps:

• Isolation of DNA from tumor biopsies, paraffin-embedded sections (FFPE), or fresh frozen tumors
• Amplification of regions of the KRAS gene using allele-specific probes
• Detection of amplification product using gel or capillary electrophoresis.
• Documentation and interpretation of results.

This test can be completed in approximately 4 hours from isolation of DNA to test result.  EntroGen’s KRAS mutation screening test identifies the following mutations:

Codon 12: Gly12Asp, Gly12Ala, Gly12Val, Gly12Ser, Gly12Arg, Gly12Cys
Codon 13: Gly13Asp
Codon 61: Gln61Leu, Gln61His, Gln61Arg

Equipment and Materials
EntroGen’s KRAS mutation screening test requires a standard thermal cycler (PCR machine), gel or capillary electrophoresis equipment, and documentation system (gel electrophoresis only).

This test includes reagents required for the PCR amplification, as well as validated reaction controls.  Columns and reagents for DNA isolation and electrophoresis are not included.

Intended Use
EntroGen’s KRAS mutation screening test reagents are provided as research use only (RUO) and must be independently validated by a CLIA-certified laboratory to be used for diagnostic purposes.

References

1. Bos et al., Cancer Research. 1989; 49:4682-4689
2. Riely et al., Clinical Cancer Research. 2008; 14:5731-5734
3. Kimura et al., Cancer Research. 2003; 63:1454-1457
4. Amado et al., Journal of Clinical Oncology. 2008; 26:1626-1634
5. Allegra et al., Journal of Clinical Oncology, 2009; 27:1-6