Downloads provided by UsageCountsMulti-center real-world comparison of the fully automated Idylla™ microsatellite instability assay with routine molecular methods and immunohistochemistry on formalin-fixed paraffin-embedded tissue of colorectal cancer
Copyright policy ) Velasco A.; Tokat F.; Bonde J.; Trim N.; Bauer E.; Meeney A.; de Leng W.; Chong G.; Dalstein V.; Kis L. L.; Lorentzen J. A.; Tomic S.; Thwaites K.; Putzova M.; Birnbaum A.; Qazi R.; Primmer V.; Dockhorn-Dworniczak B.; Hernandez-Losa J.; Soares F. A.; Gertler A. A.; Kalman M.; Wong C.; Carraro D. M.; Sousa A. C.; Reis R. M.; Fox S. B.; Fassan M.; Brevet M.; Merkelbach-Bruse S.; Colling R.; Soilleux E.; Teo R. Y. W.; D'Haene N.; Nolet S.; Ristimaki A.; Vaisanen T.; Chapusot C.; Soruri A.; Unger T.; Wecgowiec J.; Biscuola M.; Frattini M.; Long A.; Campregher P. V.; Matias-Guiu X.;
Multi-center real-world comparison of the fully automated Idylla™ microsatellite instability assay with routine molecular methods and immunohistochemistry on formalin-fixed paraffin-embedded tissue of colorectal cancer
AbstractMicrosatellite instability (MSI) is present in 15–20% of primary colorectal cancers. MSI status is assessed to detect Lynch syndrome, guide adjuvant chemotherapy, determine prognosis, and use as a companion test for checkpoint blockade inhibitors. Traditionally, MSI status is determined by immunohistochemistry or molecular methods. The Idylla™ MSI Assay is a fully automated molecular method (including automated result interpretation), using seven novel MSI biomarkers (ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A, SULF2) and not requiring matched normal tissue. In this real-world global study, 44 clinical centers performed Idylla™ testing on a total of 1301 archived colorectal cancer formalin-fixed, paraffin-embedded (FFPE) tissue sections and compared Idylla™ results against available results from routine diagnostic testing in those sites. MSI mutations detected with the Idylla™ MSI Assay were equally distributed over the seven biomarkers, and 84.48% of the MSI-high samples had ≥ 5 mutated biomarkers, while 98.25% of the microsatellite-stable samples had zero mutated biomarkers. The concordance level between the Idylla™ MSI Assay and immunohistochemistry was 96.39% (988/1025); 17/37 discordant samples were found to be concordant when a third method was used. Compared with routine molecular methods, the concordance level was 98.01% (789/805); third-method analysis found concordance for 8/16 discordant samples. The failure rate of the Idylla™ MSI Assay (0.23%; 3/1301) was lower than that of referenced immunohistochemistry (4.37%; 47/1075) or molecular assays (0.86%; 7/812). In conclusion, lower failure rates and high concordance levels were found between the Idylla™ MSI Assay and routine tests.
- University of Minho Portugal
- Utrecht University Netherlands
- University of Oxford United Kingdom
- University of Melbourne Australia
- Queen's Hospital United Kingdom
Colorectal cancer; FFPE clinical tissue samples; IdyllaTM MSI assay; Microsatellite instability; Multi-center study, Tissue Fixation, [SDV]Life Sciences [q-bio], DNA Mutational Analysis, Idylla™ MSI assay, Intestí gros - Càncer - Patogènesi, MSI assay, Neoplasias colorrectales, FENÓMENOS Y PROCESOS::fenómenos genéticos::variación genética::mutación::inestabilidad genómica::fenómenos genéticos::inestabilidad de microsatélites, RISK, Satèl·lits (Genètica), Paraffin Embedding, TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::técnicas y procedimientos diagnósticos::técnicas de laboratorio clínico::técnicas citológicas::histocitoquímica::inmunohistoquímica, TUMORS, Immunohistochemistry, [SDV] Life Sciences [q-bio], Idylla™MSI assay, Otros calificadores::Otros calificadores::Otros calificadores::/patología, Repeticiones de microsatélite, Original Article, Microsatellite Instability, PHENOMENA AND PROCESSES::Genetic Phenomena::Genetic Variation::Mutation::Genomic Instability::Genetic Phenomena::Microsatellite Instability, Colorectal Neoplasms, DISEASES::Neoplasms::Neoplasms by Site::Digestive System Neoplasms::Gastrointestinal Neoplasms::Intestinal Neoplasms::Colorectal Neoplasms, 610, Multi-center study, Pathology and Forensic Medicine, Fixatives, Diagnòstic immunohistoquímic, ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias del sistema digestivo::neoplasias gastrointestinales::neoplasias intestinales::neoplasias colorrectales, Predictive Value of Tests, Formaldehyde, Journal Article, Biomarkers, Tumor, Humans, Molecular Biology, FFPE clinical tissue samples, Other subheadings::Other subheadings::Other subheadings::/pathology, Microsatellite instability ; Idylla™MSI assay ; Colorectal cancer ; Multi-center study ; FFPE clinical tissue samples, Automation, Laboratory, Mutación, FFPE clinical tissue sample, Reproducibility of Results, Formaldehído, Cell Biology, Idylla\&\#8482, Colorectal cancer, Biomedicine, Biomarcadores, Mutation, Microsatellite instability, ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Diagnostic Techniques and Procedures::Clinical Laboratory Techniques::Cytological Techniques::Histocytochemistry::Immunohistochemistry, Inestabilidad de microsatélites, Idylla™, Inmunohistoquímica
Colorectal cancer; FFPE clinical tissue samples; IdyllaTM MSI assay; Microsatellite instability; Multi-center study, Tissue Fixation, [SDV]Life Sciences [q-bio], DNA Mutational Analysis, Idylla™ MSI assay, Intestí gros - Càncer - Patogènesi, MSI assay, Neoplasias colorrectales, FENÓMENOS Y PROCESOS::fenómenos genéticos::variación genética::mutación::inestabilidad genómica::fenómenos genéticos::inestabilidad de microsatélites, RISK, Satèl·lits (Genètica), Paraffin Embedding, TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::técnicas y procedimientos diagnósticos::técnicas de laboratorio clínico::técnicas citológicas::histocitoquímica::inmunohistoquímica, TUMORS, Immunohistochemistry, [SDV] Life Sciences [q-bio], Idylla™MSI assay, Otros calificadores::Otros calificadores::Otros calificadores::/patología, Repeticiones de microsatélite, Original Article, Microsatellite Instability, PHENOMENA AND PROCESSES::Genetic Phenomena::Genetic Variation::Mutation::Genomic Instability::Genetic Phenomena::Microsatellite Instability, Colorectal Neoplasms, DISEASES::Neoplasms::Neoplasms by Site::Digestive System Neoplasms::Gastrointestinal Neoplasms::Intestinal Neoplasms::Colorectal Neoplasms, 610, Multi-center study, Pathology and Forensic Medicine, Fixatives, Diagnòstic immunohistoquímic, ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias del sistema digestivo::neoplasias gastrointestinales::neoplasias intestinales::neoplasias colorrectales, Predictive Value of Tests, Formaldehyde, Journal Article, Biomarkers, Tumor, Humans, Molecular Biology, FFPE clinical tissue samples, Other subheadings::Other subheadings::Other subheadings::/pathology, Microsatellite instability ; Idylla™MSI assay ; Colorectal cancer ; Multi-center study ; FFPE clinical tissue samples, Automation, Laboratory, Mutación, FFPE clinical tissue sample, Reproducibility of Results, Formaldehído, Cell Biology, Idylla\&\#8482, Colorectal cancer, Biomedicine, Biomarcadores, Mutation, Microsatellite instability, ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Diagnostic Techniques and Procedures::Clinical Laboratory Techniques::Cytological Techniques::Histocytochemistry::Immunohistochemistry, Inestabilidad de microsatélites, Idylla™, Inmunohistoquímica
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These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
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This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
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This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
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This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
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