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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
A. Velasco, F. Tokat, J. Bonde, N. Trim, E. Bauer, A. Meeney, W. de Leng, G. Chong, V. Dalstein, LL. Kis, JA. Lorentzen, S. Tomić, K. Thwaites, M. Putzová, A. Birnbaum, R. Qazi, V. Primmer, B. Dockhorn-Dworniczak, J. Hernández-Losa, FA. Soares,...
Jazyk angličtina Země Německo
Typ dokumentu srovnávací studie, časopisecké články, multicentrická studie
NLK
ProQuest Central
od 2003-01-01 do Před 1 rokem
Medline Complete (EBSCOhost)
od 2011-01-01 do Před 1 rokem
Nursing & Allied Health Database (ProQuest)
od 2003-01-01 do Před 1 rokem
Health & Medicine (ProQuest)
od 2003-01-01 do Před 1 rokem
- MeSH
- fixace tkání * MeSH
- fixativa MeSH
- formaldehyd MeSH
- imunohistochemie * MeSH
- kolorektální nádory chemie genetika patologie MeSH
- laboratorní automatizace MeSH
- lidé MeSH
- mikrosatelitní nestabilita * MeSH
- mutace * MeSH
- mutační analýza DNA * MeSH
- nádorové biomarkery * analýza genetika MeSH
- prediktivní hodnota testů MeSH
- reprodukovatelnost výsledků MeSH
- zalévání tkání do parafínu * MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- srovnávací studie MeSH
Microsatellite 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.
Anatomia Patológica Rede D'Or São Paulo SP Brazil
Bioptická laboratoř s r o Laboratory of Molecular Genetics Plzeň Czech Republic
Cellular Pathology Newcastle Upon Tyne Hospitals NHS Foundation Trust Newcastle upon Tyne UK
Département de Pathologie et Biologie Cellulaire Université de Montréal Montreal Québec Canada
Department of Clinical Pathology and Cytology Karolinska University Hospital Stockholm Sweden
Department of Pathology Acıbadem Mehmet Ali Aydınlar University Istanbul Turkey
Department of Pathology Erasme Hospital Université Libre de Bruxelles Brussels Belgium
Department of Pathology Forensic Medicine and Cytology University Hospital Split Split Croatia
Department of Pathology Hadassah Medical Center Jerusalem Israel
Department of Pathology Hospital Universitari Vall d'Hebron Barcelona Spain
Department of Pathology Tan Tock Seng Hospital Novena Republic of Singapore
Department of Pathology University Medical Center Utrecht Utrecht The Netherlands
Department of Pathology University of Cambridge Cambridge UK
GenoMed Diagnósticos de Medicina Molecular SA Lisbon Portugal
Hospital Israelita Albert Einstein São Paulo Brazil
ICVS 3B's PT Government Associate Laboratory Braga Guimarães Portugal
Institut für Pathologie Evangelisches Krankenhaus BETHESDA Zu Duisburg GmbH Duisburg Germany
Institut für Pathologie und Molekularpathologie Pforzheim Germany
Institut für Pathologie University of Leipzig Leipzig Germany
Institute of Pathology Dessau Germany
Institute of Pathology University Hospital Cologne Cologne Germany
Laboratoire de Biopathologie Unité INSERM UMR S 1250 CHU Reims Reims France
Laboratory of Molecular Pathology Institute of Pathology Locarno Switzerland
Life and Health Sciences Research Institute School of Medicine University of Minho Braga Portugal
Martin's Biopsy Center Ltd Martin Slovak Republic
Molecular Oncology Research Center Barretos Cancer Hospital Barretos SP Brazil
Molecular Pathology Centre Jewish General Hospital McGill University Montreal Quebec Canada
Molecular Pathology Laboratory Department of Pathology afs 134 Hvidovre Hospital Hvidovre Denmark
Molecular Pathology Unit Department of Pathology Oslo University Hospital Oslo Norway
Nuffield Department of Surgical Sciences University of Oxford Oxford UK
Ophthalmic Pathology Laboratory Histopathology Royal Hallamshire Hospital Glossop Road Sheffield UK
Pathologisch Bakteriologisches Institut Kaiser Franz Josef Spital Vienna Austria
Pathology Peter MacCallum Cancer Centre and University of Melbourne Vic Australia
Platform of Somatic Oncology of Burgundy CHU Dijon France
Spanish Biomedical Research Network Centre in Oncology Madrid Spain
Städtisches Klinikum Karlsruhe gGmbH Institut für Pathologie Karlsruhe Germany
Surgical Pathology Unit Department of Medicine University of Padua Padua Italy
Citace poskytuje Crossref.org
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