lunes, 9 de julio de 2018

Multi-center evaluation of the Idylla™ NRAS-BRAF Mutation Test in metastatic colorectal cancer. - PubMed - NCBI

2018 Jun 26. pii: S1525-1578(18)30095-3. doi: 10.1016/j.jmoldx.2018.05.008. [Epub ahead of print]

Multi-center evaluation of the Idylla™ NRAS-BRAF Mutation Test in metastatic colorectal cancer.

Prieto-Potin I1, Montagut C2, Bellosillo B3, Evans M4, Smith M4, Melchior L5, Reiltin W6, Bennett M6, Pennati V7, Castiglione F7, Bürrig KF8, Cooper U8, Dockhorn-Dworniczak B9, Rossenbach C9, Luna-Aguirre CM10, Barrera-Saldaña HA10, Machado JC11, Costa JL11, Yacobi R12, Tabibian-Keissar H12, Buglioni S13, Ronchetti L13, Douglas-Berger L14, Dubbink HJ14, Alorini M15, Sabourin JC15, Rojo F16.

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Abstract

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 very 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 (five mutations). A multi-center 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 to those obtained earlier by routine reference methods, including next-generation sequencing, pyrosequencing, mass-spectrometry-, and 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.