Multi-center evaluation of the fully automated PCR-based Idylla™ KRAS mutation assay for rapid KRAS mutation status determination on formalin-fixed paraffin-embedded tissue of human colorectal cancer
<p>Since the advent of monoclonal antibodies against epidermal growth factor receptor (EGFR) in colorectal cancer therapy, the determination of RAS mutational status is needed for therapeutic decision-making. Most prevalent in colorectal cancer are <em>KRAS</em> exon 2 mutations (4...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Journal article |
| Language: | English |
| Published: |
Public Library of Science
2016
|
| _version_ | 1797070722204434432 |
|---|---|
| author | Solassol, J Vendrell, J Märkl, B Haas, C Bellosillo, B Montagut, C Smith, M O'Sullivan, B D'Haene, N Le Mercier, M Grauslund, M Melchior, L Burt, E Cotter, F Stieber, D Schmitt, F Schmitt, F Motta, V Lauricella, C Colling, R Soilleux, E Fassan, M Mescoli, C Collin, C Pagès, J Sillekens, P |
| author_facet | Solassol, J Vendrell, J Märkl, B Haas, C Bellosillo, B Montagut, C Smith, M O'Sullivan, B D'Haene, N Le Mercier, M Grauslund, M Melchior, L Burt, E Cotter, F Stieber, D Schmitt, F Schmitt, F Motta, V Lauricella, C Colling, R Soilleux, E Fassan, M Mescoli, C Collin, C Pagès, J Sillekens, P |
| author_sort | Solassol, J |
| collection | OXFORD |
| description | <p>Since the advent of monoclonal antibodies against epidermal growth factor receptor (EGFR) in colorectal cancer therapy, the determination of RAS mutational status is needed for therapeutic decision-making. Most prevalent in colorectal cancer are <em>KRAS</em> exon 2 mutations (40% prevalence); lower prevalence is observed for <em>KRAS</em> exon 3 and 4 mutations (6%) and <em>NRAS</em>exon 2, 3, and 4 mutations (5%). The Idylla<sup>™</sup> KRAS Mutation Test on the molecular diagnostics Idylla<sup>™</sup> platform is a simple (<2 minutes hands-on time), highly reliable, and rapid (approximately 2 hours turnaround time) <em>in vitro diagnostic</em> sample-to-result solution. This test enables qualitative detection of 21 mutations in codons 12, 13, 59, 61, 117, and 146 of the <em>KRAS</em> oncogene being clinically relevant according to the latest clinical guidelines. Here, the performance of the Idylla<sup>™</sup> KRAS Mutation Assay, for Research Use Only, was assessed on archived formalin-fixed paraffin-embedded (FFPE) tissue sections by comparing its results with the results previously obtained by routine reference approaches for <em>KRAS</em> genotyping. In case of discordance, samples were assessed further by additional methods. Among the 374 colorectal cancer FFPE samples tested, the overall concordance between the Idylla<sup>™</sup> KRAS Mutation Assay and the confirmed reference routine test results was found to be 98.9%. The Idylla<sup>™</sup> KRAS Mutation Assay enabled detection of 5 additional KRAS-mutated samples not detected previously with reference methods. As conclusion the Idylla<sup>™</sup> KRAS Mutation Test can be applied as routine tool in any clinical setting, without needing molecular infrastructure or expertise, to guide the personalized treatment of colorectal cancer patients.</p> |
| first_indexed | 2024-03-06T22:43:02Z |
| format | Journal article |
| id | oxford-uuid:5c4025e5-5f20-4d22-8dc6-f28193d451aa |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-06T22:43:02Z |
| publishDate | 2016 |
| publisher | Public Library of Science |
| record_format | dspace |
| spelling | oxford-uuid:5c4025e5-5f20-4d22-8dc6-f28193d451aa2022-03-26T17:27:01ZMulti-center evaluation of the fully automated PCR-based Idylla™ KRAS mutation assay for rapid KRAS mutation status determination on formalin-fixed paraffin-embedded tissue of human colorectal cancerJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:5c4025e5-5f20-4d22-8dc6-f28193d451aaEnglishSymplectic Elements at OxfordPublic Library of Science2016Solassol, JVendrell, JMärkl, BHaas, CBellosillo, BMontagut, CSmith, MO'Sullivan, BD'Haene, NLe Mercier, MGrauslund, MMelchior, LBurt, ECotter, FStieber, DSchmitt, FSchmitt, FMotta, VLauricella, CColling, RSoilleux, EFassan, MMescoli, CCollin, CPagès, JSillekens, P<p>Since the advent of monoclonal antibodies against epidermal growth factor receptor (EGFR) in colorectal cancer therapy, the determination of RAS mutational status is needed for therapeutic decision-making. Most prevalent in colorectal cancer are <em>KRAS</em> exon 2 mutations (40% prevalence); lower prevalence is observed for <em>KRAS</em> exon 3 and 4 mutations (6%) and <em>NRAS</em>exon 2, 3, and 4 mutations (5%). The Idylla<sup>™</sup> KRAS Mutation Test on the molecular diagnostics Idylla<sup>™</sup> platform is a simple (<2 minutes hands-on time), highly reliable, and rapid (approximately 2 hours turnaround time) <em>in vitro diagnostic</em> sample-to-result solution. This test enables qualitative detection of 21 mutations in codons 12, 13, 59, 61, 117, and 146 of the <em>KRAS</em> oncogene being clinically relevant according to the latest clinical guidelines. Here, the performance of the Idylla<sup>™</sup> KRAS Mutation Assay, for Research Use Only, was assessed on archived formalin-fixed paraffin-embedded (FFPE) tissue sections by comparing its results with the results previously obtained by routine reference approaches for <em>KRAS</em> genotyping. In case of discordance, samples were assessed further by additional methods. Among the 374 colorectal cancer FFPE samples tested, the overall concordance between the Idylla<sup>™</sup> KRAS Mutation Assay and the confirmed reference routine test results was found to be 98.9%. The Idylla<sup>™</sup> KRAS Mutation Assay enabled detection of 5 additional KRAS-mutated samples not detected previously with reference methods. As conclusion the Idylla<sup>™</sup> KRAS Mutation Test can be applied as routine tool in any clinical setting, without needing molecular infrastructure or expertise, to guide the personalized treatment of colorectal cancer patients.</p> |
| spellingShingle | Solassol, J Vendrell, J Märkl, B Haas, C Bellosillo, B Montagut, C Smith, M O'Sullivan, B D'Haene, N Le Mercier, M Grauslund, M Melchior, L Burt, E Cotter, F Stieber, D Schmitt, F Schmitt, F Motta, V Lauricella, C Colling, R Soilleux, E Fassan, M Mescoli, C Collin, C Pagès, J Sillekens, P Multi-center evaluation of the fully automated PCR-based Idylla™ KRAS mutation assay for rapid KRAS mutation status determination on formalin-fixed paraffin-embedded tissue of human colorectal cancer |
| title | Multi-center evaluation of the fully automated PCR-based Idylla™ KRAS mutation assay for rapid KRAS mutation status determination on formalin-fixed paraffin-embedded tissue of human colorectal cancer |
| title_full | Multi-center evaluation of the fully automated PCR-based Idylla™ KRAS mutation assay for rapid KRAS mutation status determination on formalin-fixed paraffin-embedded tissue of human colorectal cancer |
| title_fullStr | Multi-center evaluation of the fully automated PCR-based Idylla™ KRAS mutation assay for rapid KRAS mutation status determination on formalin-fixed paraffin-embedded tissue of human colorectal cancer |
| title_full_unstemmed | Multi-center evaluation of the fully automated PCR-based Idylla™ KRAS mutation assay for rapid KRAS mutation status determination on formalin-fixed paraffin-embedded tissue of human colorectal cancer |
| title_short | Multi-center evaluation of the fully automated PCR-based Idylla™ KRAS mutation assay for rapid KRAS mutation status determination on formalin-fixed paraffin-embedded tissue of human colorectal cancer |
| title_sort | multi center evaluation of the fully automated pcr based idylla™ kras mutation assay for rapid kras mutation status determination on formalin fixed paraffin embedded tissue of human colorectal cancer |
| work_keys_str_mv | AT solassolj multicenterevaluationofthefullyautomatedpcrbasedidyllakrasmutationassayforrapidkrasmutationstatusdeterminationonformalinfixedparaffinembeddedtissueofhumancolorectalcancer AT vendrellj multicenterevaluationofthefullyautomatedpcrbasedidyllakrasmutationassayforrapidkrasmutationstatusdeterminationonformalinfixedparaffinembeddedtissueofhumancolorectalcancer AT marklb multicenterevaluationofthefullyautomatedpcrbasedidyllakrasmutationassayforrapidkrasmutationstatusdeterminationonformalinfixedparaffinembeddedtissueofhumancolorectalcancer AT haasc multicenterevaluationofthefullyautomatedpcrbasedidyllakrasmutationassayforrapidkrasmutationstatusdeterminationonformalinfixedparaffinembeddedtissueofhumancolorectalcancer AT bellosillob multicenterevaluationofthefullyautomatedpcrbasedidyllakrasmutationassayforrapidkrasmutationstatusdeterminationonformalinfixedparaffinembeddedtissueofhumancolorectalcancer AT montagutc multicenterevaluationofthefullyautomatedpcrbasedidyllakrasmutationassayforrapidkrasmutationstatusdeterminationonformalinfixedparaffinembeddedtissueofhumancolorectalcancer AT smithm multicenterevaluationofthefullyautomatedpcrbasedidyllakrasmutationassayforrapidkrasmutationstatusdeterminationonformalinfixedparaffinembeddedtissueofhumancolorectalcancer AT osullivanb multicenterevaluationofthefullyautomatedpcrbasedidyllakrasmutationassayforrapidkrasmutationstatusdeterminationonformalinfixedparaffinembeddedtissueofhumancolorectalcancer AT dhaenen multicenterevaluationofthefullyautomatedpcrbasedidyllakrasmutationassayforrapidkrasmutationstatusdeterminationonformalinfixedparaffinembeddedtissueofhumancolorectalcancer AT lemercierm multicenterevaluationofthefullyautomatedpcrbasedidyllakrasmutationassayforrapidkrasmutationstatusdeterminationonformalinfixedparaffinembeddedtissueofhumancolorectalcancer AT grauslundm multicenterevaluationofthefullyautomatedpcrbasedidyllakrasmutationassayforrapidkrasmutationstatusdeterminationonformalinfixedparaffinembeddedtissueofhumancolorectalcancer AT melchiorl multicenterevaluationofthefullyautomatedpcrbasedidyllakrasmutationassayforrapidkrasmutationstatusdeterminationonformalinfixedparaffinembeddedtissueofhumancolorectalcancer AT burte multicenterevaluationofthefullyautomatedpcrbasedidyllakrasmutationassayforrapidkrasmutationstatusdeterminationonformalinfixedparaffinembeddedtissueofhumancolorectalcancer AT cotterf multicenterevaluationofthefullyautomatedpcrbasedidyllakrasmutationassayforrapidkrasmutationstatusdeterminationonformalinfixedparaffinembeddedtissueofhumancolorectalcancer AT stieberd multicenterevaluationofthefullyautomatedpcrbasedidyllakrasmutationassayforrapidkrasmutationstatusdeterminationonformalinfixedparaffinembeddedtissueofhumancolorectalcancer AT schmittf multicenterevaluationofthefullyautomatedpcrbasedidyllakrasmutationassayforrapidkrasmutationstatusdeterminationonformalinfixedparaffinembeddedtissueofhumancolorectalcancer AT schmittf multicenterevaluationofthefullyautomatedpcrbasedidyllakrasmutationassayforrapidkrasmutationstatusdeterminationonformalinfixedparaffinembeddedtissueofhumancolorectalcancer AT mottav multicenterevaluationofthefullyautomatedpcrbasedidyllakrasmutationassayforrapidkrasmutationstatusdeterminationonformalinfixedparaffinembeddedtissueofhumancolorectalcancer AT lauricellac multicenterevaluationofthefullyautomatedpcrbasedidyllakrasmutationassayforrapidkrasmutationstatusdeterminationonformalinfixedparaffinembeddedtissueofhumancolorectalcancer AT collingr multicenterevaluationofthefullyautomatedpcrbasedidyllakrasmutationassayforrapidkrasmutationstatusdeterminationonformalinfixedparaffinembeddedtissueofhumancolorectalcancer AT soilleuxe multicenterevaluationofthefullyautomatedpcrbasedidyllakrasmutationassayforrapidkrasmutationstatusdeterminationonformalinfixedparaffinembeddedtissueofhumancolorectalcancer AT fassanm multicenterevaluationofthefullyautomatedpcrbasedidyllakrasmutationassayforrapidkrasmutationstatusdeterminationonformalinfixedparaffinembeddedtissueofhumancolorectalcancer AT mescolic multicenterevaluationofthefullyautomatedpcrbasedidyllakrasmutationassayforrapidkrasmutationstatusdeterminationonformalinfixedparaffinembeddedtissueofhumancolorectalcancer AT collinc multicenterevaluationofthefullyautomatedpcrbasedidyllakrasmutationassayforrapidkrasmutationstatusdeterminationonformalinfixedparaffinembeddedtissueofhumancolorectalcancer AT pagesj multicenterevaluationofthefullyautomatedpcrbasedidyllakrasmutationassayforrapidkrasmutationstatusdeterminationonformalinfixedparaffinembeddedtissueofhumancolorectalcancer AT sillekensp multicenterevaluationofthefullyautomatedpcrbasedidyllakrasmutationassayforrapidkrasmutationstatusdeterminationonformalinfixedparaffinembeddedtissueofhumancolorectalcancer |