title: Clinical performance evaluation of a sensitive, rapid low-throughput test for KRAS mutation analysis using formalin-fixed, paraffin-embedded tissue samples.
abstract: 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 Idylla™ KRAS Mutation Test on FFPE tumor samples of patients with mCRC.
  
  
  
  KRAS 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.
  
  
  
  Data 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.
  
  
  
  The 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.
authors.affiliation: Pathology Department, University Hospital Antwerp, Wilrijkstraat 10, 2650, Edegem, Belgium. christine.weyn@uza.be.
authors.forename: Christine
authors.identifier: 0000-0002-7801-7000
authors.initials: C
authors.lastname: Weyn
authors.affiliation: Pathology Department, University Hospital Antwerp, Wilrijkstraat 10, 2650, Edegem, Belgium.
authors.forename: Sofie
authors.initials: S
authors.lastname: Van Raemdonck
authors.affiliation: Pathology Department, University Hospital Antwerp, Wilrijkstraat 10, 2650, Edegem, Belgium.
authors.forename: Robina
authors.initials: R
authors.lastname: Dendooven
authors.affiliation: Pathology Department, University Hospital Antwerp, Wilrijkstraat 10, 2650, Edegem, Belgium.
authors.forename: Vincent
authors.initials: V
authors.lastname: Maes
authors.affiliation: Pathology Department, University Hospital Antwerp, Wilrijkstraat 10, 2650, Edegem, Belgium.
authors.forename: Karen
authors.initials: K
authors.lastname: Zwaenepoel
authors.affiliation: Pathology Department, University Hospital Antwerp, Wilrijkstraat 10, 2650, Edegem, Belgium.
authors.forename: Suzan
authors.initials: S
authors.lastname: Lambin
authors.affiliation: Pathology Department, University Hospital Antwerp, Wilrijkstraat 10, 2650, Edegem, Belgium.|Centre for Oncological Research (CORE), University of Antwerp, Universiteitsplein 1, 2610, Wilrijk, Belgium.
authors.forename: Patrick
authors.initials: P
authors.lastname: Pauwels
mesh_terms: D015179:Colorectal Neoplasms / Q000175:diagnosis / Q000235:genetics*; D004252:DNA Mutational Analysis / Q000379:methods*; D005557:Formaldehyde; D006801:Humans; D057230:Limit of Detection; D009154:Mutation / Q000235:genetics; D016612:Paraffin Embedding; D016283:Proto-Oncogene Proteins p21(ras) / Q000235:genetics*
chemical_list: C117307:KRAS protein, human; D005557:Formaldehyde; D016283:Proto-Oncogene Proteins p21(ras)
keywords: FFPE; Idylla; KRAS; Metastatic colorectal carcinoma; Mutation analysis