EpiDirect enables rapid bisulfite-free MGMT promoter methylation testing in IDH-wildtype glioblastoma with high agreement across established assays.

Abstract

MGMT promoter methylation is a critical biomarker for predicting alkylating chemotherapy response in IDH-wildtype glioblastoma. However, the lack of an accepted reference detection method complicates clinical implementation. Current assays differ in their target CpG sites, analytical procedures, and classification thresholds. Here, we present an expanded paired analytical comparison of EpiDirect, a bisulfite-free quantitative PCR (qPCR) assay, with 4 established or emerging methods in clinical glioblastoma samples: pyrosequencing, MGMT-STP27 derived from EPIC methylation array data, methylation-specific PCR (MSP), and methylation-specific digital PCR (MS-dPCR).