Multicenter Evaluation of the Idylla NRAS-BRAF Mutation Test in Metastatic Colorectal Cancer

Iván Prieto-Potin, Clara Montagut, Beatriz Bellosillo, Matthew Evans, Matthew Smith, Linea Melchior, Werner Reiltin, Michael Bennett, Veronica Pennati, Francesca Castiglione, Karl Friedrich Bürrig, Ulrike Cooper, Barbara Dockhorn-Dworniczak, Christiana Rossenbach, Claudia M. Luna-Aguirre, Hugo A. Barrera-Saldaña, José C. Machado, José L. Costa, Rinat Yacobi, Hilla Tabibian-KeissarSimonetta Buglioni, Livia Ronchetti, Lotte Douglas-Berger, Hendrikus J. Dubbink, Mohammed Alorini, Jean Christophe Sabourin, Federico Rojo

Research output: Contribution to journalArticlepeer-review

18 Scopus citations


Treatment of colorectal cancer (CRC) with monoclonal antibodies against epidermal growth factor receptor requires the assessment of the mutational status of exons 2, 3, and 4 of the NRAS and KRAS oncogenes. Moreover, the mutational status of exon 15 of the BRAF oncogene is a marker of poor prognosis in CRC. The Idylla NRAS-BRAF Mutation Test is a reliable, simple (<2 minutes hands-on time), and quick (<2 hours turnaround time) sample-to-result solution, enabling the detection of clinically relevant mutations in NRAS (18 mutations) and BRAF (5 mutations). A multicenter study was conducted in 14 centers using the Idylla NRAS-BRAF Mutation Test to assess the NRAS and BRAF mutational status of 418 formalin-fixed, paraffin-embedded tissue samples from CRC patients. Results were compared with those obtained earlier by routine reference methods, including next-generation sequencing, pyrosequencing, mass spectrometry–based assays, PCR-based assays, and Sanger sequencing. In case of discordance, additional tests were performed by digital droplet PCR. Overall, after testing confirmation and excluding invalids/errors by design, concordances between the Idylla NRAS-BRAF Mutation Test and the reference test results were found in almost perfect agreement. In conclusion, the Idylla NRAS-BRAF Mutation Test enables the routine detection of all NRAS and BRAF mutations deemed clinically relevant according to the latest clinical guidelines, without necessitating molecular expertise or infrastructure.

Original languageEnglish
Pages (from-to)664-676
Number of pages13
JournalJournal of Molecular Diagnostics
Issue number5
StatePublished - Sep 2018
Externally publishedYes

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© 2018 American Society for Investigative Pathology and the Association for Molecular Pathology


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