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MDxHealth and Merck KGaA extend Agreement for use of MGMT Assay in Brain Cancer Clinical Trials


DURHAM, NC, and LIEGE, BELGIUM - MDxHealth SA (NYSE Euronext: MDXH), a leading molecular diagnostics company in the field of personalized medicine, announced today that it will extend its agreement with Merck KGaA, Darmstadt, Germany, for use of MDxHealth’s MGMT assay in Merck KGaA’s brain cancer clinical trials. Financial terms of the agreement are not disclosed.

Merck KGaA’s is currently investigating its integrin inhibitor cilengitide in a Phase III trial (CENTRIC) in newly diagnosed patients with glioblastoma with a methylated promoter of the methylguanine-DNA methyltransferase (MGMT) gene in the tumor tissue. Glioblastoma is the most aggressive and most common form of primary brain tumors.

Prior to patient enrollment in CENTRIC, MGMT gene promoter testing performed at the laboratories of MDxHealth is required. CENTRIC is the first prospective international controlled Phase III oncology trial that uses the MGMT assay as a standard to determine the patient population for a trial.

With the new agreement the partners are continuing their collaboration that started with the pivotal Phase III CENTRIC trial initiated in 2008. Merck KGaA is also conducting the CORE trial, which is a randomized controlled Phase II study with cilengitide in newly diagnosed glioblastoma patients. As in the CENTRIC trial, the CORE trial will rely on MDxHealth’s MGMT gene promoter methylation assay for the stratification of patients. However, while patients enrolled in the CENTRIC trial require a positive methylation status of the MGMT promoter in the tumor, patients in the CORE trial require an unmethylated status of the MGMT gene promoter.

About cilengitide
Cilengitide is currently being developed by Merck Serono, a division of Merck KGaA. Cilengitide is the first in a new class of investigational anti-cancer therapies called integrin inhibitors in Phase III of development; it is currently being investigated for the treatment of glioblastoma, squamous cell carcinoma of the head and neck and non-small cell lung cancer.

Integrins are cell surface receptors that are improperly regulated in many cancer types, leading to enhanced tumor growth and survival, and invasiveness. Integrins are fundamental in the process of angiogenesis (blood vessel growth) - a process that is essential for tumors as it enables them to grow past a finite size.

In addition to the Merck Serono-sponsored studies, the U.S. National Cancer Institute (NCI) is sponsoring a number of clinical trials under a Cooperative Research and Development Agreement (CRADA) with Merck Serono for the development of cilengitide. In the United States and Canada, cilengitide is being developed by EMD Serono, an affiliate of Merck KGaA.

About the MGMT assay: PredictMDx for BrainTM
PredictMDx for Brain, MDxHealth’s most advanced personalized treatment product is a test for predicting patient response to alkylating agents, a class of chemotherapy drugs. The test assesses the methylation status of the MGMT gene, which is correlated with response to drug therapy. The MGMT gene is a crucial DNA repair gene. MDxHealth PredictMDx for Bain test determines the methylation status of the MGMT gene in tumor tissue, and can be used as a predictive assay for the treatment of brain cancer. MDxHealth PredictMDx for Brain test has been shown on thousands of patients to be able to distinguish which cancer patients are likely to respond to the most commonly used class of brain cancer drugs called alkylating agents. This patented methylated gene test is attractive for new brain cancer drug developers since they can more easily target their new drugs to the patients who usually do not respond to the traditional alkylating agent drug regime.

About MDxHealth
MDxHealth is a leading molecular diagnostics company that develops and commercializes oncology-based molecular diagnostic testing and companion diagnostics for personalized medicine. The company’s numerous cancer tests are based on proprietary gene methylation technology and assist physicians with the diagnosis of cancer, prognosis of recurrence risk, and prediction of response to a specific therapy. MDxHealth collaborates with leading cancer research center such as Johns Hopkins University, Duke University, Lovelace Respiratory Research Institute, Eastern Virginia Medical School, Cleveland Clinic, Memorial Sloan Kettering, and major European academic medical centers. The company has a number of commercial and collaborative partnerships with LabCorp, Merck & Co./Schering Plough, GlaxoSmithKline Biologicals, Roche, Merck KGaA, Qiagen, Pfizer and other industry leaders.

This press release contains forward-looking statements and estimates with respect to the anticipated future performance of MDxHealth and the market in which it operates. Such statements and estimates are based on assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable but may not prove to be correct. Actual events are difficult to predict, may depend upon factors that are beyond the Company’s control, and may turn out to be materially different. MDxHealth expressly disclaims any obligation to update any such forward-looking statements in this release to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based unless required by law or regulation


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