Clinical performance evaluation of a sensitive, rapid low-throughput test for KRAS mutation analysis using formalin-fixed, paraffin-embedded tissue samples

BMC Cancer

Research Article

Suzan Lambin¹  Robina Dendooven¹  Vincent Maes¹  Sofie Van Raemdonck¹  Christine Weyn¹  Karen Zwaenepoel¹  Patrick Pauwels² 

[1] Pathology Department, University Hospital Antwerp, Wilrijkstraat 10, 2650, Edegem, Belgium;Pathology Department, University Hospital Antwerp, Wilrijkstraat 10, 2650, Edegem, Belgium;Centre for Oncological Research (CORE), University of Antwerp, Universiteitsplein 1, 2610, Wilrijk, Belgium;

关键词: KRAS;    Metastatic colorectal carcinoma;    FFPE;    Mutation analysis;    Idylla;   

DOI  :  10.1186/s12885-017-3112-0

 received in 2016-08-09, accepted in 2017-02-04,  发布年份 2017

来源: Springer

【 摘 要 】

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.

【 授权许可】

CC BY   
© The Author(s). 2017