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:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositorio:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.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
Descrição
Resumo: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.

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