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MDxHealth, Merck KGaA Expand Glioblastoma Drug-CDx Deal

NEW YORK (GenomeWeb News) – MDxHealth today announced its collaborative agreement with Merck KGaA has been expanded to include the continued development and worldwide commercialization of MDxHealth's PredictMDx for Glioblastoma test.

The test is a methylguanine-DNA methyltransferase (MGMT) diagnostic test to identify glioblastoma patients who may benefit from cilengitide-based therapies currently under investigation in combination with temozolomide and radiotherapy. The test assesses the methylation status of the MGMT gene promoter. The MGMT gene is thought to contribute to cellular DNA repair, and when methylated it is expressed in abnormal amounts, suggesting increased responsiveness of tumor cells to some chemotherapeutic regimens, MDxHealth said.

Merck's cilengitide drug candidate is in Phase III development for newly diagnosed glioblastoma. Merck will support MDxHealth's development and regulatory activities around the PredictMDx test as part of the expanded collaboration. After regulatory approval, the test and cilengitide will be launched together.

In 2008 MDxHealth inked a deal providing MGMT gene promoter methylation testing services to Merck's clinical trial program for cilengitide. Last year the firms expanded the deal to include the use of the MGMT assay in Merck's brain cancer drug clinical trials.

PredictMDx has been used for identifying and stratifying newly diagnosed glioblastoma patients enrolled in cilengitide clinical studies and who may benefit from the drug used in combination with temozolomide and radiotherapy.

"Our collaboration with MDxHealth reflects the importance of diagnostics in the field of personalizing cancer care, an approach that Merck Serono is actively investing in with the ultimate goal to identify those patients who are most likely to benefit from a certain treatment through the use of a biomarker-guided approach," Annalisa Jenkins, head of global drug development and medical for Merck Serono, the division of Merck KGaA that is developing cilengitide, said in a statement. "We are hoping that this will help to improve the future treatment of patients with glioblastoma, a disease which today has high unmet medical needs."

Financial and other terms of the deal were not disclosed.