MDxHealth and Merck KGaA expanded their diagnostics collaboration to encompass further development and commercialization of MDxHealth’s MGMT (methylguanine-DNA methyltransferase) diagnostic test PredictMDx™ for glioblastoma as a test to identify patients who may benefit from treatment using Merck Serono’s Phase III-stage integrin inhibitor cilengitide.
Under terms of the deal Merck will support MDxHealth’s development and regulatory activities for the MGMT test and, after regulatory approval, coordinate launch of the test alongside cilengitide for glioblastoma therapy. The PredictMDx for glioblastoma test assesses the methylation status of the MGMT gene promotor as an indicator of whether tumor cells will respond to some types of chemotherapy agents.
The assay has already been applied to identify and stratify newly diagnosed glioblastoma patients enrolled in clinical studies evaluating cilengitide in combination with temozolomide and radiotherapy. MDxHealth has additional agreements in place for use of the PredictMDx for glioblastoma assay to help select patients for Phase III studies evaluating other investigational drugs in combination with temozolomide and radiotherapy.