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Clinical validation of the CE-IVD marked Therascreen MGMT kit in a cohort of glioblastoma patients

Véronique Quillien 1, 2 Audrey Lavenu 3 François Ducray 4 David Meyronet 5 Olivier Chinot 6 Frédéric Fina 7, 8 Marc Sanson 9, 10, 11 Catherine Carpentier 9 Lucie Karayan-Tapon 12, 13 Pierre Rivet 13 Natacha Entz-Werle 14 Michèle Legrain 15, 16 Emmanuèle Lechapt Zalcman 17 Guenaelle Levallet 17 Fabienne Escande 18 Carole Ramirez 18 Dan Chiforeanu 19 Elodie Vauleon 20, 1 Dominique Figarella-Branger 8, 21
Abstract : BACKGROUND: Pyrosequencing is recognized as a strong technique to analyze the MGMT status of glioblastoma patients. The most commonly used assay, quantifies the methylation levels of CpGs 74 to 78. A more recent CE-marked In Vitro Diagnostic Medical Device (CE-IVD) assay, Therascreen, analyzes CpGs 76-79.METHODS: We performed a comparison of these two assays to evaluate the potential impact of this shift in analyzed CpGs. Therascreen analysis was centrally performed for 102 glioblastoma patients, who were part of a prospective multicenter trial.RESULTS: A strong correlation was observed for the mean values of the 4 or 5 analyzed CpGs, with lower values recorded using the Therascreen assay, especially for values greater than 20%. When considering a classification in 3 categories (> 12%: methylated; ⩽ 8%: unmethylated; 9-12%: grey zone), 93% of patients were identically classified between the two assays. Using a binary classification, 95% and 97% of patients were identically classified with cut-offs of 8% and 12%, respectively. A strong prognostic significance was observed for both assays: median overall survival were 15.9 months and 34.9 months for respectively unmethylated and methylated patients with either test. CONCLUSION: The results demonstrate that these assays may be used interchangeably.
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Véronique Quillien, Audrey Lavenu, François Ducray, David Meyronet, Olivier Chinot, et al.. Clinical validation of the CE-IVD marked Therascreen MGMT kit in a cohort of glioblastoma patients. Cancer Biomarkers, IOS Press, 2017, 20 (4), pp.435-441. ⟨10.3233/CBM-170191⟩. ⟨hal-01680957⟩

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