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

Velasco Sánchez, Ana; Tokat, Fatma; Bonde, Jesper; Trim, Nicola; Bauer, Elisabeth; Meeney, Adam; de Leng, Wendy; Chong, George; Dalstein, Véronique; Kis, Lorand L.; Lorentzen, Jon A.; Tomić, Snjezana; Thwaites, Keeley; Putzová, Martina; Birnbaum, Astrid; Qazi, Romena; Primmer, Vanessa; Dockhorn-Dworniczak, Barbara; Hernández-Losa, Javier; Soares, Fernando A.; Gertler, Asaf A.; Kalman, Michal; Wong, Chris; Carraro, Dirce M.; Sousa, Ana C.; Reis, Rui M.; Fox, Stephen B.; Fassan, Matteo; Brevet, Marie; Merkelbach Bruse, Sabine; Colling, Richard; Soilleux, Elizabeth; Teo, Ryan Yee Wei; D'Haene, Nicky; Nolet, Serge; Ristimäki, Ari; Väisänen, Timo; Chapusot, Caroline; Soruri, Afsaneh; Unger, Tina; Wecgowiec, Johanna; Biscuola, Michele; Frattini, Milo; Long, Anna; Campregher, Paulo V.; Matias-Guiu, Xavier

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

Microsatellite instability (MSI) is present in 15–20% of primary colorectal cancers. MSI status is assessed to detect Lynchsyndrome, guide adjuvant chemotherapy, determine prognosis, and use as a companion test for checkpoint blockade inhibitors.Traditionally, MSI status is determined by immunohisto...

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Detalhes bibliográficos
Autores:	Velasco Sánchez, Ana, Tokat, Fatma, Bonde, Jesper, Trim, Nicola, Bauer, Elisabeth, Meeney, Adam, de Leng, Wendy, Chong, George, Dalstein, Véronique, Kis, Lorand L., Lorentzen, Jon A., Tomić, Snjezana, Thwaites, Keeley, Putzová, Martina, Birnbaum, Astrid, Qazi, Romena, Primmer, Vanessa, Dockhorn-Dworniczak, Barbara, Hernández-Losa, Javier, Soares, Fernando A., Gertler, Asaf A., Kalman, Michal, Wong, Chris, Carraro, Dirce M., Sousa, Ana C., Reis, Rui M., Fox, Stephen B., Fassan, Matteo, Brevet, Marie, Merkelbach Bruse, Sabine, Colling, Richard, Soilleux, Elizabeth, Teo, Ryan Yee Wei, D'Haene, Nicky, Nolet, Serge, Ristimäki, Ari, Väisänen, Timo, Chapusot, Caroline, Soruri, Afsaneh, Unger, Tina, Wecgowiec, Johanna, Biscuola, Michele, Frattini, Milo, Long, Anna, Campregher, Paulo V., Matias-Guiu, Xavier
Formato:	artículo
Estado:	Versión publicada
Fecha de publicación:	2021
País:	España
Recursos:	Universitat de Lleida (UdL)
Repositorio:	Repositori Obert UdL
OAI Identifier:	oai:repositori.udl.cat:10459.1/72839
Acesso em linha:	https://doi.org/10.1007/s00428-020-02962-x http://hdl.handle.net/10459.1/72839
Access Level:	acceso abierto
Palavra-chave:	Microsatellite instability Idylla™MSI assay Colorectal cancer Multi-center study FFPE clinical tissue sample

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repository_id_str
spelling	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 cancerVelasco Sánchez, AnaTokat, FatmaBonde, JesperTrim, NicolaBauer, ElisabethMeeney, Adamde Leng, WendyChong, GeorgeDalstein, VéroniqueKis, Lorand L.Lorentzen, Jon A.Tomić, SnjezanaThwaites, KeeleyPutzová, MartinaBirnbaum, AstridQazi, RomenaPrimmer, VanessaDockhorn-Dworniczak, BarbaraHernández-Losa, JavierSoares, Fernando A.Gertler, Asaf A.Kalman, MichalWong, ChrisCarraro, Dirce M.Sousa, Ana C.Reis, Rui M.Fox, Stephen B.Fassan, MatteoBrevet, MarieMerkelbach Bruse, SabineColling, RichardSoilleux, ElizabethTeo, Ryan Yee WeiD'Haene, NickyNolet, SergeRistimäki, AriVäisänen, TimoChapusot, CarolineSoruri, AfsanehUnger, TinaWecgowiec, JohannaBiscuola, MicheleFrattini, MiloLong, AnnaCampregher, Paulo V.Matias-Guiu, XavierMicrosatellite instabilityIdylla™MSI assayColorectal cancerMulti-center studyFFPE clinical tissue sampleMicrosatellite instability (MSI) is present in 15–20% of primary colorectal cancers. MSI status is assessed to detect Lynchsyndrome, 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 fullyautomated 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 clinicalcenters performed Idylla™testing on a total of 1301 archived colorectal cancer formalin-fixed, paraffin-embedded (FFPE) tissuesections and compared Idylla™results against available results from routine diagnostic testing in those sites. MSI mutationsdetected with the Idylla™MSI Assay were equally distributed over the seven biomarkers, and 84.48% of the MSI-high sampleshad≥5 mutated biomarkers, while 98.25% of the microsatellite-stable samples had zero mutated biomarkers. The concordancelevel between the Idylla™MSI Assay and immunohistochemistry was 96.39% (988/1025); 17/37 discordant samples were foundto 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.Springer-Verlag2021info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://doi.org/10.1007/s00428-020-02962-xhttp://hdl.handle.net/10459.1/72839reponame:Repositori Obert UdL instname:Universitat de Lleida (UdL)InglésReproducció del document publicat a: https://doi.org/10.1007/s00428-020-02962-xVirchows Archiv, European Journal of Pathology, 2021, v. 478, núm. 5, p. 851-863cc-by (c) The Authors, 2020info:eu-repo/semantics/openAccesshttp://creativecommons.org/licenses/by/4.0/oai:repositori.udl.cat:10459.1/728392026-06-24T12:42:17Z
dc.title.none.fl_str_mv	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
title	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
spellingShingle	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 Velasco Sánchez, Ana Microsatellite instability Idylla™MSI assay Colorectal cancer Multi-center study FFPE clinical tissue sample
title_short	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
title_full	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
title_fullStr	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
title_full_unstemmed	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
title_sort	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
dc.creator.none.fl_str_mv	Velasco Sánchez, Ana Tokat, Fatma Bonde, Jesper Trim, Nicola Bauer, Elisabeth Meeney, Adam de Leng, Wendy Chong, George Dalstein, Véronique Kis, Lorand L. Lorentzen, Jon A. Tomić, Snjezana Thwaites, Keeley Putzová, Martina Birnbaum, Astrid Qazi, Romena Primmer, Vanessa Dockhorn-Dworniczak, Barbara Hernández-Losa, Javier Soares, Fernando A. Gertler, Asaf A. Kalman, Michal Wong, Chris Carraro, Dirce M. Sousa, Ana C. Reis, Rui M. Fox, Stephen B. Fassan, Matteo Brevet, Marie Merkelbach Bruse, Sabine Colling, Richard Soilleux, Elizabeth Teo, Ryan Yee Wei D'Haene, Nicky Nolet, Serge Ristimäki, Ari Väisänen, Timo Chapusot, Caroline Soruri, Afsaneh Unger, Tina Wecgowiec, Johanna Biscuola, Michele Frattini, Milo Long, Anna Campregher, Paulo V. Matias-Guiu, Xavier
author	Velasco Sánchez, Ana
author_facet	Velasco Sánchez, Ana Tokat, Fatma Bonde, Jesper Trim, Nicola Bauer, Elisabeth Meeney, Adam de Leng, Wendy Chong, George Dalstein, Véronique Kis, Lorand L. Lorentzen, Jon A. Tomić, Snjezana Thwaites, Keeley Putzová, Martina Birnbaum, Astrid Qazi, Romena Primmer, Vanessa Dockhorn-Dworniczak, Barbara Hernández-Losa, Javier Soares, Fernando A. Gertler, Asaf A. Kalman, Michal Wong, Chris Carraro, Dirce M. Sousa, Ana C. Reis, Rui M. Fox, Stephen B. Fassan, Matteo Brevet, Marie Merkelbach Bruse, Sabine Colling, Richard Soilleux, Elizabeth Teo, Ryan Yee Wei D'Haene, Nicky Nolet, Serge Ristimäki, Ari Väisänen, Timo Chapusot, Caroline Soruri, Afsaneh Unger, Tina Wecgowiec, Johanna Biscuola, Michele Frattini, Milo Long, Anna Campregher, Paulo V. Matias-Guiu, Xavier
author_role	author
author2	Tokat, Fatma Bonde, Jesper Trim, Nicola Bauer, Elisabeth Meeney, Adam de Leng, Wendy Chong, George Dalstein, Véronique Kis, Lorand L. Lorentzen, Jon A. Tomić, Snjezana Thwaites, Keeley Putzová, Martina Birnbaum, Astrid Qazi, Romena Primmer, Vanessa Dockhorn-Dworniczak, Barbara Hernández-Losa, Javier Soares, Fernando A. Gertler, Asaf A. Kalman, Michal Wong, Chris Carraro, Dirce M. Sousa, Ana C. Reis, Rui M. Fox, Stephen B. Fassan, Matteo Brevet, Marie Merkelbach Bruse, Sabine Colling, Richard Soilleux, Elizabeth Teo, Ryan Yee Wei D'Haene, Nicky Nolet, Serge Ristimäki, Ari Väisänen, Timo Chapusot, Caroline Soruri, Afsaneh Unger, Tina Wecgowiec, Johanna Biscuola, Michele Frattini, Milo Long, Anna Campregher, Paulo V. Matias-Guiu, Xavier
author2_role	author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author
dc.subject.none.fl_str_mv	Microsatellite instability Idylla™MSI assay Colorectal cancer Multi-center study FFPE clinical tissue sample
topic	Microsatellite instability Idylla™MSI assay Colorectal cancer Multi-center study FFPE clinical tissue sample
description	Microsatellite instability (MSI) is present in 15–20% of primary colorectal cancers. MSI status is assessed to detect Lynchsyndrome, 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 fullyautomated 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 clinicalcenters performed Idylla™testing on a total of 1301 archived colorectal cancer formalin-fixed, paraffin-embedded (FFPE) tissuesections and compared Idylla™results against available results from routine diagnostic testing in those sites. MSI mutationsdetected with the Idylla™MSI Assay were equally distributed over the seven biomarkers, and 84.48% of the MSI-high sampleshad≥5 mutated biomarkers, while 98.25% of the microsatellite-stable samples had zero mutated biomarkers. The concordancelevel between the Idylla™MSI Assay and immunohistochemistry was 96.39% (988/1025); 17/37 discordant samples were foundto 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.
publishDate	2021
dc.date.none.fl_str_mv	2021
dc.type.none.fl_str_mv	info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion
format	article
status_str	publishedVersion
dc.identifier.none.fl_str_mv	https://doi.org/10.1007/s00428-020-02962-x http://hdl.handle.net/10459.1/72839
url	https://doi.org/10.1007/s00428-020-02962-x http://hdl.handle.net/10459.1/72839
dc.language.none.fl_str_mv	Inglés
language_invalid_str_mv	Inglés
dc.relation.none.fl_str_mv	Reproducció del document publicat a: https://doi.org/10.1007/s00428-020-02962-x Virchows Archiv, European Journal of Pathology, 2021, v. 478, núm. 5, p. 851-863
dc.rights.none.fl_str_mv	cc-by (c) The Authors, 2020 info:eu-repo/semantics/openAccess http://creativecommons.org/licenses/by/4.0/
rights_invalid_str_mv	cc-by (c) The Authors, 2020 http://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv	openAccess
dc.publisher.none.fl_str_mv	Springer-Verlag
publisher.none.fl_str_mv	Springer-Verlag
dc.source.none.fl_str_mv	reponame:Repositori Obert UdL instname:Universitat de Lleida (UdL)
instname_str	Universitat de Lleida (UdL)
reponame_str	Repositori Obert UdL
collection	Repositori Obert UdL
repository.name.fl_str_mv
repository.mail.fl_str_mv
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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

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