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 Article Swipe
Jérôme Solassol
,
Julie A. Vendrell
,
Bruno Märkl
,
Christian Haas
,
Beatríz Bellosillo
,
Clara Montagut
,
Matthew R. Smith
,
Brendan O’Sullivan
,
Nicky D’Haene
,
Marie Le Mercier
,
Morten Grauslund
,
Linea Cecilie Melchior
,
Emma Burt
,
Finbarr E. Cotter
,
Daniel Stieber
,
Fernando de Lander Schmitt
,
Valentina Motta
,
Calogero Lauricella
,
Richard Colling
,
Elizabeth J. Soilleux
,
Matteo Fassan
,
Claudia Mescoli
,
Christine Collin
,
Jean‐Christophe Pagès
,
Peter Sillekens
·
YOU?
·
· 2016
· Open Access
·
· DOI: https://doi.org/10.1371/journal.pone.0163444
YOU?
·
· 2016
· Open Access
·
· DOI: https://doi.org/10.1371/journal.pone.0163444
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.
Related Topics
Concepts
KRAS
Colorectal cancer
Concordance
Medicine
Neuroblastoma RAS viral oncogene homolog
Panitumumab
Cancer
Genotyping
Oncology
Mutation
Molecular diagnostics
Internal medicine
Cancer research
Bioinformatics
Genotype
Biology
Genetics
Gene
Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1371/journal.pone.0163444
- https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0163444&type=printable
- OA Status
- gold
- Cited By
- 35
- References
- 27
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W2523946272
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W2523946272Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1371/journal.pone.0163444Digital Object Identifier
- 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 CancerWork title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2016Year of publication
- Publication date
-
2016-09-29Full publication date if available
- Authors
-
Jérôme Solassol, Julie A. Vendrell, Bruno Märkl, Christian Haas, Beatríz Bellosillo, Clara Montagut, Matthew R. Smith, Brendan O’Sullivan, Nicky D’Haene, Marie Le Mercier, Morten Grauslund, Linea Cecilie Melchior, Emma Burt, Finbarr E. Cotter, Daniel Stieber, Fernando de Lander Schmitt, Valentina Motta, Calogero Lauricella, Richard Colling, Elizabeth J. Soilleux, Matteo Fassan, Claudia Mescoli, Christine Collin, Jean‐Christophe Pagès, Peter SillekensList of authors in order
- Landing page
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https://doi.org/10.1371/journal.pone.0163444Publisher landing page
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https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0163444&type=printableDirect link to full text PDF
- Open access
-
YesWhether a free full text is available
- OA status
-
goldOpen access status per OpenAlex
- OA URL
-
https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0163444&type=printableDirect OA link when available
- Concepts
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KRAS, Colorectal cancer, Concordance, Medicine, Neuroblastoma RAS viral oncogene homolog, Panitumumab, Cancer, Genotyping, Oncology, Mutation, Molecular diagnostics, Internal medicine, Cancer research, Bioinformatics, Genotype, Biology, Genetics, GeneTop concepts (fields/topics) attached by OpenAlex
- Cited by
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35Total citation count in OpenAlex
- Citations by year (recent)
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2023: 1, 2022: 5, 2020: 12, 2019: 6, 2018: 5Per-year citation counts (last 5 years)
- References (count)
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27Number of works referenced by this work
- Related works (count)
-
10Other works algorithmically related by OpenAlex
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| abstract_inverted_index.qualitative | 95 |
| abstract_inverted_index.therapeutic | 25 |
| abstract_inverted_index.KRAS-mutated | 210 |
| abstract_inverted_index.discordance, | 163 |
| abstract_inverted_index.personalized | 244 |
| abstract_inverted_index.prevalence); | 38 |
| abstract_inverted_index.determination | 17 |
| abstract_inverted_index.(approximately | 82 |
| abstract_inverted_index.formalin-fixed | 139 |
| abstract_inverted_index.infrastructure | 238 |
| abstract_inverted_index.decision-making. | 26 |
| abstract_inverted_index.sample-to-result | 90 |
| abstract_inverted_index.paraffin-embedded | 140 |
| cited_by_percentile_year.max | 99 |
| cited_by_percentile_year.min | 89 |
| corresponding_author_ids | https://openalex.org/A5083788727, https://openalex.org/A5065012596, https://openalex.org/A5027344325, https://openalex.org/A5046467806, https://openalex.org/A5101655026, https://openalex.org/A5041377715, https://openalex.org/A5038828714, https://openalex.org/A5035054833, https://openalex.org/A5062739895, https://openalex.org/A5061639336, https://openalex.org/A5110190250, https://openalex.org/A5113550534, https://openalex.org/A5046301295, https://openalex.org/A5111955533, https://openalex.org/A5064868880, https://openalex.org/A5021723290, https://openalex.org/A5046935755, https://openalex.org/A5063681577, https://openalex.org/A5101555760, https://openalex.org/A5057242702, https://openalex.org/A5042280442, https://openalex.org/A5091227333, https://openalex.org/A5019299921, https://openalex.org/A5064267997, https://openalex.org/A5107869062 |
| countries_distinct_count | 8 |
| institutions_distinct_count | 25 |
| corresponding_institution_ids | https://openalex.org/I132053463, https://openalex.org/I138689650, https://openalex.org/I2799307867, https://openalex.org/I2801259928, https://openalex.org/I2802007660, https://openalex.org/I2802054198, https://openalex.org/I2802709434, https://openalex.org/I4210094195, https://openalex.org/I4210095477, https://openalex.org/I4210113372, https://openalex.org/I4210130874, https://openalex.org/I4210136145, https://openalex.org/I4210140335, https://openalex.org/I4210144605, https://openalex.org/I4210147381, https://openalex.org/I4210156109 |
| sustainable_development_goals[0].id | https://metadata.un.org/sdg/9 |
| sustainable_development_goals[0].score | 0.5899999737739563 |
| sustainable_development_goals[0].display_name | Industry, innovation and infrastructure |
| citation_normalized_percentile.value | 0.91827464 |
| citation_normalized_percentile.is_in_top_1_percent | False |
| citation_normalized_percentile.is_in_top_10_percent | True |