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.
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 KRAS exon 2 mutations (40% prevalence); lower prevalen...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Public Library of Science (PLoS)
2016-01-01
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| Series: | PLoS ONE |
| Online Access: | http://europepmc.org/articles/PMC5042411?pdf=render |
| _version_ | 1818986180802248704 |
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| author | Jérôme Solassol Julie Vendrell Bruno Märkl Christian Haas Beatriz Bellosillo Clara Montagut Matthew Smith Brendan O'Sullivan Nicky D'Haene Marie Le Mercier Morten Grauslund Linea Cecilie Melchior Emma Burt Finbarr Cotter Daniel Stieber Fernando de Lander Schmitt Fernando de Lander Schmitt Valentina Motta Calogero Lauricella Richard Colling Elizabeth Soilleux Matteo Fassan Claudia Mescoli Christine Collin Jean-Christophe Pagès Peter Sillekens |
| author_facet | Jérôme Solassol Julie Vendrell Bruno Märkl Christian Haas Beatriz Bellosillo Clara Montagut Matthew Smith Brendan O'Sullivan Nicky D'Haene Marie Le Mercier Morten Grauslund Linea Cecilie Melchior Emma Burt Finbarr Cotter Daniel Stieber Fernando de Lander Schmitt Fernando de Lander Schmitt Valentina Motta Calogero Lauricella Richard Colling Elizabeth Soilleux Matteo Fassan Claudia Mescoli Christine Collin Jean-Christophe Pagès Peter Sillekens |
| author_sort | Jérôme Solassol |
| collection | DOAJ |
| description | 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 KRAS exon 2 mutations (40% prevalence); lower prevalence is observed for KRAS exon 3 and 4 mutations (6%) and NRAS exon 2, 3, and 4 mutations (5%). The Idylla™ KRAS Mutation Test on the molecular diagnostics Idylla™ platform is a simple (<2 minutes hands-on time), highly reliable, and rapid (approximately 2 hours turnaround time) in vitro diagnostic sample-to-result solution. This test enables qualitative detection of 21 mutations in codons 12, 13, 59, 61, 117, and 146 of the KRAS oncogene being clinically relevant according to the latest clinical guidelines. Here, the performance of the Idylla™ 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 KRAS 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™ KRAS Mutation Assay and the confirmed reference routine test results was found to be 98.9%. The Idylla™ KRAS Mutation Assay enabled detection of 5 additional KRAS-mutated samples not detected previously with reference methods. As conclusion the Idylla™ 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. |
| first_indexed | 2024-12-20T18:46:42Z |
| format | Article |
| id | doaj.art-92de7acfa3d44182aea78f62e0050f5d |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2024-12-20T18:46:42Z |
| publishDate | 2016-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj.art-92de7acfa3d44182aea78f62e0050f5d2022-12-21T19:29:42ZengPublic Library of Science (PLoS)PLoS ONE1932-62032016-01-01119e016344410.1371/journal.pone.0163444Multi-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.Jérôme SolassolJulie VendrellBruno MärklChristian HaasBeatriz BellosilloClara MontagutMatthew SmithBrendan O'SullivanNicky D'HaeneMarie Le MercierMorten GrauslundLinea Cecilie MelchiorEmma BurtFinbarr CotterDaniel StieberFernando de Lander SchmittFernando de Lander SchmittValentina MottaCalogero LauricellaRichard CollingElizabeth SoilleuxMatteo FassanClaudia MescoliChristine CollinJean-Christophe PagèsPeter SillekensSince 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 KRAS exon 2 mutations (40% prevalence); lower prevalence is observed for KRAS exon 3 and 4 mutations (6%) and NRAS exon 2, 3, and 4 mutations (5%). The Idylla™ KRAS Mutation Test on the molecular diagnostics Idylla™ platform is a simple (<2 minutes hands-on time), highly reliable, and rapid (approximately 2 hours turnaround time) in vitro diagnostic sample-to-result solution. This test enables qualitative detection of 21 mutations in codons 12, 13, 59, 61, 117, and 146 of the KRAS oncogene being clinically relevant according to the latest clinical guidelines. Here, the performance of the Idylla™ 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 KRAS 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™ KRAS Mutation Assay and the confirmed reference routine test results was found to be 98.9%. The Idylla™ KRAS Mutation Assay enabled detection of 5 additional KRAS-mutated samples not detected previously with reference methods. As conclusion the Idylla™ 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.http://europepmc.org/articles/PMC5042411?pdf=render |
| spellingShingle | Jérôme Solassol Julie Vendrell Bruno Märkl Christian Haas Beatriz Bellosillo Clara Montagut Matthew Smith Brendan O'Sullivan Nicky D'Haene Marie Le Mercier Morten Grauslund Linea Cecilie Melchior Emma Burt Finbarr Cotter Daniel Stieber Fernando de Lander Schmitt Fernando de Lander Schmitt Valentina Motta Calogero Lauricella Richard Colling Elizabeth Soilleux Matteo Fassan Claudia Mescoli Christine Collin Jean-Christophe Pagès Peter Sillekens 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. PLoS ONE |
| 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 |
| url | http://europepmc.org/articles/PMC5042411?pdf=render |
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