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

authors

• Quillien Véronique
• Lavenu Audrey
• Ducray François
• Meyronet David
• Chinot Olivier
• Fina Frédéric
• Sanson Marc
• Carpentier Catherine
• Karayan-Tapon Lucie
• Rivet Pierre
• Entz-Werle Natacha
• Legrain Michèle
• Zalcman Emmanuèle Lechapt
• Levallet Guenaelle
• Escande Fabienne
• Ramirez Carole
• Chiforeanu Dan
• Vauleon Elodie
• Figarella-Branger Dominique

keywords

• MGMT methylation
• Pyrosequencing
• Glioblastoma
• CE-IVD kit

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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