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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2021Author
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.
Suggested citation
Velasco Sánchez, Ana;
Tokat, Fatma;
Bonde, Jesper;
Trim, Nicola;
Bauer, Elisabeth;
Meeney, Adam;
...
Matias-Guiu, Xavier.
(2021)
.
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.
Virchows Archiv, European Journal of Pathology, 2021, v. 478, núm. 5, p. 851-863.
https://doi.org/10.1007/s00428-020-02962-x.
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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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Virchows Archiv, European Journal of Pathology, 2021, v. 478, núm. 5, p. 851-863European research projects
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