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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.


ABSTRACT: 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.

SUBMITTER: Velasco A 

PROVIDER: S-EPMC8099763 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature

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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.

Velasco Ana A   Tokat Fatma F   Bonde Jesper J   Trim Nicola N   Bauer Elisabeth E   Meeney Adam A   de Leng Wendy W   Chong George G   Dalstein Véronique V   Kis Lorand L LL   Lorentzen Jon A JA   Tomić Snjezana S   Thwaites Keeley K   Putzová Martina M   Birnbaum Astrid A   Qazi Romena R   Primmer Vanessa V   Dockhorn-Dworniczak Barbara B   Hernández-Losa Javier J   Soares Fernando A FA   Gertler Asaf A AA   Kalman Michal M   Wong Chris C   Carraro Dirce M DM   Sousa Ana C AC   Reis Rui M RM   Fox Stephen B SB   Fassan Matteo M   Brevet Marie M   Merkelbach-Bruse Sabine S   Colling Richard R   Soilleux Elizabeth E   Teo Ryan Yee Wei RYW   D'Haene Nicky N   Nolet Serge S   Ristimäki Ari A   Väisänen Timo T   Chapusot Caroline C   Soruri Afsaneh A   Unger Tina T   Wecgowiec Johanna J   Biscuola Michele M   Frattini Milo M   Long Anna A   Campregher Paulo V PV   Matias-Guiu Xavier X  

Virchows Archiv : an international journal of pathology 20201110 5


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  ...[more]

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