Abstract
BackgroundTesting for KRAS mutations in metastatic colorectal cancer (mCRC) on formalin-fixed, paraffin embedded (FFPE) tumor tissue has become standard of care. Different molecular methods exist to determine hotspot KRAS mutations in exon 2, 3 and 4, but testing is often limited by the sensitivity and the speed of analysis. The aim of this retrospective study was to establish the clinical performance of the Idylla™ KRAS Mutation Test on FFPE tumor samples of patients with mCRC.MethodsKRAS mutation analysis was performed using the therascreen KRAS on the RotorGene Q platform (CE-IVD; Qiagen) and results were subsequently compared to the Idylla™ KRAS Mutation Test. Discordant result testing was performed with massive parallel sequencing or alternative routine approaches.ResultsData from 182 samples were used to show that the overall agreement between the two methods for mutation characterization was 96.7% [95%CI: 93.0%-98.5%]. Six out of 182 samples (3.3%) showed true discordant results.ConclusionThe Idylla™ KRAS Mutation Test allows for a fast and reliable analysis of FFPE samples with a turnaround-time of two hours without the need of molecular infrastructure or expertise in order to guide the personalized treatment of colorectal cancer patients.
Highlights
Testing for kirsten rat sarcoma viral oncogene homolog (RAS) (KRAS) mutations in metastatic colorectal cancer on formalin-fixed, paraffin embedded (FFPE) tumor tissue has become standard of care
This study aimed at comparing the clinical performance of the IdyllaTM KRAS Mutation Test to the therascreen KRAS RGQ PCR Kit for 182 valid results obtained from metastatic colorectal cancer (mCRC) FFPE samples
Tissue specimens This study was approved by the Ethical committee of the University Hospital Antwerp (UZA) and includes FFPE tumor samples from 230 patients with mCRC that were referred for KRAS mutation analysis at our institute (UZA) between 2010 and 2015
Summary
Testing for KRAS mutations in metastatic colorectal cancer (mCRC) on formalin-fixed, paraffin embedded (FFPE) tumor tissue has become standard of care. Different molecular methods exist to determine hotspot KRAS mutations in exon 2, 3 and 4, but testing is often limited by the sensitivity and the speed of analysis The aim of this retrospective study was to establish the clinical performance of the IdyllaTM KRAS Mutation Test on FFPE tumor samples of patients with mCRC. Treatment options for metastatic CRC include targeted therapies with monoclonal antibodies (mAbs), namely cetuximab (Erbitux, Merk KgaA, Darmstadt, Germany) and panitumumab (Vectibix, Amgen Thousand Oaks, CA, United States) [3]. These molecules both target the extracellular domain of the epidermal growth factor receptor (EGFR) protein and compete with ligands, leading to the. Extended RAS testing of tumor tissue (primary or metastatic) beyond KRAS exon 2 is recommended both by the European Society of Medical Oncology (ESMO) and by the National Comprehensive Cancer Network (NCCN) [3, 6, 8]
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