Velasco, Ana, Tokat, Fatma, Bonde, Jesper, Trim, Nicola, Bauer, Elisabeth, Meeney, Adam, de Leng, Wendy, Chong, George, Dalstein, Veronique, Kis, Lorand L., Lorentzen, Jon A., Tomic, Snjezana, Thwaites, Keeley, Putzova, Martina, Birnbaum, Astrid, Qazi, Romena, Primmer, Vanessa, Dockhorn-Dworniczak, Barbara, Hernandez-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, Ristimaki, Ari, Vaisanen, Timo, Chapusot, Caroline, Soruri, Afsaneh, Unger, Tina, Wecgowiec, Johanna, Biscuola, Michele, Frattini, Milo, Long, Anna, Campregher, Paulo, V and Matias-Guiu, Xavier . Multi-center real-world comparison of the fully automated Idylla (TM) microsatellite instability assay with routine molecular methods and immunohistochemistry on formalin-fixed paraffin-embedded tissue of colorectal cancer. Virchows Arch.. NEW YORK: SPRINGER. ISSN 1432-2307

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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 (TM) 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 (TM) testing on a total of 1301 archived colorectal cancer formalin-fixed, paraffin-embedded (FFPE) tissue sections and compared Idylla (TM) results against available results from routine diagnostic testing in those sites. MSI mutations detected with the Idylla (TM) 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 (TM) 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 (TM) 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 (TM) MSI Assay and routine tests.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Velasco, AnaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tokat, FatmaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bonde, JesperUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Trim, NicolaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bauer, ElisabethUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Meeney, AdamUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
de Leng, WendyUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Chong, GeorgeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dalstein, VeroniqueUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kis, Lorand L.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lorentzen, Jon A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tomic, SnjezanaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Thwaites, KeeleyUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Putzova, MartinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Birnbaum, AstridUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Qazi, RomenaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Primmer, VanessaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dockhorn-Dworniczak, BarbaraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hernandez-Losa, JavierUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Soares, Fernando A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gertler, Asaf A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kalman, MichalUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wong, ChrisUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Carraro, Dirce M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sousa, Ana C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Reis, Rui M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fox, Stephen B.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fassan, MatteoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Brevet, MarieUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Merkelbach-Bruse, SabineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Colling, RichardUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Soilleux, ElizabethUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Teo, Ryan Yee WeiUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
D'Haene, NickyUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Nolet, SergeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ristimaki, AriUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vaisanen, TimoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Chapusot, CarolineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Soruri, AfsanehUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Unger, TinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wecgowiec, JohannaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Biscuola, MicheleUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Frattini, MiloUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Long, AnnaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Campregher, Paulo, VUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Matias-Guiu, XavierUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-311773
DOI: 10.1007/s00428-020-02962-x
Journal or Publication Title: Virchows Arch.
Publisher: SPRINGER
Place of Publication: NEW YORK
ISSN: 1432-2307
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
TUMORS; RISKMultiple languages
PathologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/31177

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