| Résumé: | <p>Since the advent of monoclonal antibodies against epidermal growth factor receptor (EGFR) in colorectal cancer therapy, the determination of RAS mutational status is needed for therapeutic decision-making. Most prevalent in colorectal cancer are <em>KRAS</em> exon 2 mutations (40% prevalence); lower prevalence is observed for <em>KRAS</em> exon 3 and 4 mutations (6%) and <em>NRAS</em>exon 2, 3, and 4 mutations (5%). The Idylla<sup>™</sup> KRAS Mutation Test on the molecular diagnostics Idylla<sup>™</sup> platform is a simple (<2 minutes hands-on time), highly reliable, and rapid (approximately 2 hours turnaround time) <em>in vitro diagnostic</em> sample-to-result solution. This test enables qualitative detection of 21 mutations in codons 12, 13, 59, 61, 117, and 146 of the <em>KRAS</em> oncogene being clinically relevant according to the latest clinical guidelines. Here, the performance of the Idylla<sup>™</sup> KRAS Mutation Assay, for Research Use Only, was assessed on archived formalin-fixed paraffin-embedded (FFPE) tissue sections by comparing its results with the results previously obtained by routine reference approaches for <em>KRAS</em> genotyping. In case of discordance, samples were assessed further by additional methods. Among the 374 colorectal cancer FFPE samples tested, the overall concordance between the Idylla<sup>™</sup> KRAS Mutation Assay and the confirmed reference routine test results was found to be 98.9%. The Idylla<sup>™</sup> KRAS Mutation Assay enabled detection of 5 additional KRAS-mutated samples not detected previously with reference methods. As conclusion the Idylla<sup>™</sup> KRAS Mutation Test can be applied as routine tool in any clinical setting, without needing molecular infrastructure or expertise, to guide the personalized treatment of colorectal cancer patients.</p>
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