MDxHealth’s MGMT Test Shown to Be Only Prognostic Factor in Journal of Clinical Oncology Report on Newly Diagnosed Brain Cancer Patients
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 (PredictMDx(TM) for Brain) was shown to be the only prognostic factor for overall survival (OS) in newly diagnosed glioblastoma multiforme (GBM) patients over the age of 70 in a study published in the Journal of Clinical Oncology (JCO)*, one of the leading cancer journals. Prognostic factors are biological markers that help determine the course and outcome of disease. The study was conducted by eight of the foremost French academic institutions to evaluate the efficacy and safety of temozolomide alone in what is considered a fragile patient population, suffering from this devastating type of brain cancer.
The authors conclude that treatment with temozolomide has an acceptable safety profile and is associated with a significant improvement of functional status in one third of patients and appears to increase survival compared with supportive care alone. Remarkably, the only prognostic factor identified by the authors was MGMT promoter methylation status, which is linked to a substantially better outcome in patients with methylation (overall survival of 31 weeks) compared to patients without methylation (overall survival of 19 weeks).
“This study confirms the results of a steadily increasing number of clinical trial reports that support the importance of MDxHealth’s PredictMDx for Brain test in clinical decision making,” said Dr. Jan Groen, CEO of MDxHealth. “It also lends further support to the outcome of the large international temozolomide Phase III study (RTOG 0525), which was recently presented at the Annual Meeting of the American Society for Clinical Oncology. Validation of our MGMT assay through publications in prestigious peer-reviewed journals such as JCO also aids our discussion with the US Food and Drug Administration regarding the use of PredictMDx for Brain as a companion diagnostic for the compound cilengitide.”
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.
* Temozolomide in Elderly Patients With Newly Diagnosed Glioblastoma and Poor Performance Status: An ANOCEF Phase II Trial. Published ahead of print as 10.1200/JCO.2011.34.8086
About the MGMT Test: PredictMDx for Brain(TM)
PredictMDx for Brain, MDxHealth’s most advanced personalized treatment product is a test for assessing patient response to alkylating agents, a class of chemotherapy drugs. The test determines 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.
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 centers 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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