Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster display

3616 - Ultra-rapid, sensitive, and fully automated extended RAS testing for metastatic colorectal cancer – evaluation of an NRAS/BRAF/EGFR492 module


10 Oct 2016


Poster display


Ellen Vercauteren


Annals of Oncology (2016) 27 (6): 401-406. 10.1093/annonc/mdw380


E. Vercauteren1, E. Bellon1, K. Vermeiren1, F. De Freitas1, E. De Haes1, S. Van Gestel1, S. Murray2, M. Grauslund3, L. Melchior3, N. D'Haene4, M. Le Mercier4, B. Bellosillo5, C. Montagut6, M. Van Brussel1, E. Sablon1, G. Maertens1

Author affiliations

  • 1 -, Biocartis, 2800 - Mechelen/BE
  • 2 Molecular Oncology, BioPath Innovations, 15124 - Athens/GR
  • 3 Pathology, Rigshospitalet, Copenhagen University Hospital, 2100 - Copenhagen/DK
  • 4 Anatomic Pathology Laboratory, Erasme University Hospital-(Universite Libre de Bruxelles), Brussels/BE
  • 5 Pathology Department, University Hospital del Mar, 08003 - Barcelona/ES
  • 6 Medical Oncology, University Hospital del Mar, Barcelona/ES


Abstract 3616


Extended RAS testing in codons 12, 13, 59, 61, 117, and 146 in exons 2, 3, and 4 of the KRAS and NRAS genes is now mandatory before anti-EGFR therapy in metastatic colorectal cancer (mCRC) patients. BRAF and EGFR ectodomain mutation status have been shown to play a crucial role in predicting non-responsiveness in mCRC patients receiving anti-EGFR therapy. Current methods for testing of extended RAS, BRAF and the new EGFR ectodomain mutations are laborious and often require 5-20 working days.


The Idylla platform (Biocartis, Mechelen, Belgium) is a CE marked, fully automated sample-to-result, real-time PCR molecular diagnostics system. The Idylla NRAS-BRAF-EGFRS492R Mutation Assay (for Research Use Only) is an assay for formalin-fixed paraffin-embedded (FFPE) tissue samples from mCRC patients for the analysis of 18 NRAS (codons 12, 13, 59, 61, 117, and 146 in exons 2, 3, and 4), 2 BRAF (codon 600), and 2 EGFR (codon 492) mutations. The Idylla NRAS-BRAF-EGFRS492R Mutation Assay was compared with routine sequencing technologies at five centers (BioPath Innovations, Copenhagen University Hospital, Hôpital Erasme, Hospital del Mar, Biocartis). In addition, LOD was established using cell lines embedded in paraffin containing defined ratios of mutants and dilutions thereof in an FFPE WT background.


Positive predictive agreement was 97.2% (n = 106), 100% (n = 40) and 100% (n = 1) and negative predictive agreement was 99.4% (n = 348), 99.5% (n = 412) and 100% (n = 444) for NRAS, BRAF and EGFR, respectively. One BRAF V600E sample detected by Idylla only was confirmed with digital droplet PCR. No cross-reactivity was observed in KRAS positive samples indicating the high specificity of the assay towards NRAS mutations. Fourteen mutations showed an LOD of ≤1%, 10 mutations of ≤5% and one mutation showed an LOD of 6%.


Given its high sensitivity and specificity, the Idylla NRAS-BRAF-EGFRS492R Mutation Assay is ideally suited for rapid detection of NRAS, BRAF and EGFR mutations. Together with the Idylla KRAS Mutation Test (CE-IVD), sample-to-result extended RAS testing on 39 mutations can now be performed in only 2 hours.

Clinical trial identification

Legal entity responsible for the study





All authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings