AI Article Synopsis

  • The study investigates the accuracy of KRAS mutation analyses across six laboratories, known to influence treatment outcomes in colorectal cancer patients.
  • Results show that three of the laboratories demonstrated almost perfect agreement with the Amgen direct sequencing results, while one showed substantial agreement, and one had only slight agreement.
  • Overall, the findings indicate that most commercial laboratories offer reliable KRAS analysis, essential for guiding treatment decisions in cancer therapy.

Article Abstract

Background: Activating mutations in the KRAS gene occur frequently in human tumors, including colorectal carcinomas; most mutations occur in codons 12 and 13. Mutations in KRAS have been associated with poor response to anti-epidermal growth factor receptor antibodies. Therefore, an accurate and readily available analysis of KRAS mutational status is needed. The aim of this study was to evaluate concordance between KRAS assays performed by 6 different laboratories.

Methods: Forty formalin-fixed paraffin-embedded colorectal cancer tumor samples were obtained. Sample sections were submitted for KRAS mutation analysis to 5 independent commercial laboratories (Agencourt, Gentris, Genzyme, HistoGeneX, and Invitek) and to the Amgen DNA Sequencing Laboratory for direct polymerase chain reaction sequencing. The assay used by Invitek is no longer commercially available and has been replaced by an alternative technique. Results from the commercial services were compared with those from Amgen direct sequencing by kappa statistics.

Results: KRAS mutations were observed in codon 12 and/or 13 in 20 of 40 (50%) samples in Amgen direct sequencing assays. Results from HistoGeneX (kappa = 0.95), Genzyme (kappa = 0.94), and Agencourt (kappa = 0.94) were in almost perfect agreement with these results, and the results from Gentris were in substantial agreement with the results from Amgen (kappa = 0.75). The Invitek allele-specific assay demonstrated slight agreement (kappa = 0.13).

Conclusions: This study provides data on the comparability of KRAS mutational analyses. The results suggest that most (but not all) commercial services provide analysis that is accurate and comparable with direct sequencing.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2879238PMC
http://dx.doi.org/10.1186/1746-1596-5-23DOI Listing

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