Development of a Robust MGMT Promoter Methylation Assay for Glioblastoma Multiforme

AACR 2020 -- The degree of methylation in the promoter region of the O-6-methylguanine-DNA methyltransferase (MGMT) gene is widely accepted as a prognostic biomarker of patient outcomes in Glioblastoma multiforme (GBM). There are a number of different assays currently available for the measurement of DNA methylation that assess methylation status by different methods and at different CpG sites in the MGMT promoter and in exon 1. There is the possibility that the various methods may produce different methylation results and thus lead to different patient treatment decisions based on the test results. Labcorp of America Holdings has provided MGMT testing services for clinical samples based upon a published assay. Because of the need to change instrumentation this assay was re-formatted, optimized and analytically validated for possible use as an In Vitro Diagnostic Device. Formalin-fixed-paraffin-embedded (FFPE) specimens from GBM patients were evaluated using standard pathology method