Richard Colling1,2,3, Lai Mun Wang1,4,5, Elizabeth Soilleux1,6. 1. Department of Cellular Pathology, Oxford University Hospitals NHS Trust, John Radcliffe Hospital, Oxford, UK. 2. Oxford Molecular Diagnostics Centre, Molecular Haematology, Oxford University Hospitals NHS Trust, John Radcliffe Hospital, Oxford, UK. 3. Department of Oncology, University of Oxford, John Radcliffe Hospital, Oxford, UK. 4. Department of Laboratory Medicine, Changi General Hospital, Singapore, Singapore. 5. Ludwig Institute for Cancer Research, University of Oxford, Old Road Campus Research Building, Oxford, UK. 6. Nuffield Division of Clinical Laboratory Sciences, University of Oxford, John Radcliffe Hospital, Oxford, UK.
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. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
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. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
Authors: Louise Johnston; Michael Power; Philip Sloan; Anna Long; Angela Silmon; Ben Chaffey; Andrea Jane Lisgo; Liam Little; Ellen Vercauteren; Torben Steiniche; Tine Meyer; John Simpson Journal: J Clin Pathol Date: 2017-09-12 Impact factor: 3.411
Authors: Mercedes Delgado-García; Birgit Weynand; Lourdes Gómez-Izquierdo; María José Hernández; Ángela María Blanco; Mar Varela; Xavier Matias-Guiu; Ernest Nadal; Bélgica Márquez-Lobo; Ana Alarcão; Enrique de Álava; Michele Biscuola Journal: BMC Cancer Date: 2020-04-03 Impact factor: 4.430