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Background  Mutations in the  KRAS  gene are associated with poor response to epidermal growth factor receptor inhibitors used in the treatment of metastatic colorectal cancer. Factors influencing  KRAS  test results in tumor specimens include: tumor heterogeneity, sample handling, slide preparation, techniques for tumor enrichment, DNA preparation, assay design and sensitivity. We evaluated comparability and consistency of  KRAS  test results among five laboratories currently being used to determine  KRAS  mutation status of metastatic colorectal cancer specimens in a large, multi-center observational study.    Findings  Twenty formalin-fixed paraffin-embedded human colorectal cancer samples from colon resections previously tested for  KRAS  mutations were selected based on mutation status (6 wild type, 8 codon 12 mutations, and 6 codon 13 mutations). We found good agreement across laboratories despite differences in mutation detection methods. Eighteen of twenty samples (90%) were concordant across all five labs. Discordant results are likely not due to laboratory error, but instead to tumor heterogeneity, contamination of the tumor sample with normal tissue, or analytic factors affecting assay sensitivity.    Conclusions  Our results indicate commercial and academic laboratories provide reliable results for the common  KRAS  gene mutations at codons 12 and 13 when an adequate percentage of tumor cells is present in the sample.

Reliability of KRAS mutation testing in metastatic colorectal cancer patients across five laboratories