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MDxHealth’s Methylation Based Companion Diagnostics Enables Better Personalized Treatment in Brain Cancer


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Data to be Presented at ASCO from RTOG 0525 International Phase III Trial of Temozolomide

DURHAM, NC, and LIEGE, BELGIUM - MDxHealth SA (NYSE Euronext: MDXH), a leading molecular diagnostics company in the field of personalized cancer treatment, today announced that its MGMT test (PredictMDxTM for Brain) has demonstrated success in personalizing brain cancer treatment in a major international phase III study. The data, obtained from a Phase III study (RTOG 0525) of temozolomide will be presented at the Annual Meeting of the American Society for Clinical Oncology (ASCO, Chicago, USA, 3-7 June) by principal investigator Mark R. Gilbert, MD (University of Texas M. D. Anderson Cancer Center) on Sunday 5th June).



MGMT (O6-methylguanine-DNA methyl transferase) is a key DNA repair enzyme produced by the MGMT gene. When the MGMT gene is methlyated, no MGMT is produced. The more MGMT present in the tumor, the more active the DNA repair. This means therapies that work by inducing DNA damage are less likely to be successful.



About the Study
The RTOG 0525 study was designed as a randomized, international phase III trial comparing standard adjuvant temozolomide (TMZ) with a dose-dense (dd) schedule in newly diagnosed glioblastoma (GBM) patients. The investigators were studying whether a continuous dose of temozolomide would be more effective than standard therapy. MDxHealth’s MGMT test was used to determine MGMT gene methylation status and molecular risk classification.

About the MGMT Test: 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 crucial to promoting DNA repair. If the MGMT gene is methylated, cancer patients tend to respond better to alkylating drug therapy. PredictMDx for Brain has been shown on thousands of patients to help identify those cancer patients that are likely to respond to the most commonly used class of brain cancer drugs (alkylating agents). This patented DNA methylation 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 for personalized medicine. The company’s 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 and 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 Serono, Pfizer, and other industry leaders. More information can be found on the Company website: www.mdxhealth.com or on twitter at the following address: www.twitter.com/mdxhealth.

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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