KRAS assay selection: sensitivity and accuracy in clinical application

KRAS mutation status is routinely tested before the administration of chemotherapeutic agents that target EGFR such as cetuximab and panitumumab. Various commercial assays to analyze KRAS mutational status are currently certified for in vitro diagnostic use. However, the differences in the operational characteristics of the different assays have not been investigated. Since different assays could be different in specificity, sensitivity and precision, studies to clarify the best option for an adequate determination of KRAS mutation status are necessary. Until a gold standard for testing KRAS mutation status is established, the treating physician must interpret the results of any given assay keeping this limitation in mind.