@article {Collingjclinpath-2017-204356, author = {Richard Colling and Lai Mun Wang and Elizabeth Soilleux}, title = {Validating a fully automated real-time PCR-based system for use in the molecular diagnostic analysis of colorectal carcinoma: a comparison with NGS and IHC}, elocation-id = {jclinpath-2017-204356}, year = {2017}, doi = {10.1136/jclinpath-2017-204356}, publisher = {BMJ Publishing Group}, abstract = {Background Molecular testing is increasingly needed in colorectal carcinoma (CRC) and the current clinically relevant mutations are in BRAF, KRAS and NRAS. This study aimed to further validate a new alternative polymerase chain reaction (PCR) platform (Idylla, Biocartis) against existing next-generation sequencing (NGS) and immunohistochemistry (IHC) assays.Methods 56 Idylla tests were performed on 43 CRC cases, in a total of 74 comparisons against an NGS panel (Ion Torrent) and the VE1 (anti-BRAF) antibody IHC. Discrepant cases were also compared with either conventional (Cobas) or droplet digital PCR (Bio-Rad).Results Idylla showed an overall concordance of 100\% (95\% CI 93\% to 100\%) with comparator molecular testing and indications were that Idylla is likely to be more sensitive than routine NGS. BRAF IHC showed 90\% concordance with NGS (95\% CI 70\% to 97\%).Conclusions This study validates Idylla in formalin-fixed, paraffin-embedded CRC tissue. BRAF IHC, however, is an unreliable substitute for molecular testing in CRC.}, issn = {0021-9746}, URL = {https://jcp.bmj.com/content/early/2017/03/14/jclinpath-2017-204356}, eprint = {https://jcp.bmj.com/content/early/2017/03/14/jclinpath-2017-204356.full.pdf}, journal = {Journal of Clinical Pathology} }