DURHAM, NC, and LIEGE, BELGIUM - June 6, 2011 - 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) was shown to successfully identify those recently diagnosed glioblastoma patients more likely to live longer and have a longer progression free time period following treatment with temozolomide. The data, obtained from an international Phase III study (RTOG 0525) of temozolomide, were presented last night at the Annual Meeting of the American Society for Clinical Oncology (ASCO, Chicago, USA) by principal investigator Mark R. Gilbert, MD (University of Texas M. D. Anderson Cancer Center).

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.

"There is pressing need for molecular tests that assist in the identification and monitoring of the most effective treatment for each individual cancer patient. This is especially true with cancer therapeutics that rely on inducing DNA damage in the tumor," explained Mark Gilbert. "The MGMT gene test was confirmed in the RTOG 0525 clinical trial to define prognosis for patients with newly diagnosed glioblastoma. Ongoing clinical trials have incorporated this now validated prognostic marker to determine if subsets of patients require alternative therapies, on the basis of prognostic information determined by the MGMT methylation testing."

"Besides re-emphasizing the feasibility of performing real-time MGMT methylation testing in tumors as a stratification factor in a multinational clinical trial, the results demonstrate that treatment decisions based on the molecular characteristics of the tumor are not only feasible but make a clinical difference," stated Dr. Jan Groen, CEO of MDxHealth. "In addition to the Phase III study of temozolomide, MDxHealth's MGMT testing services are now being provided for numerous Phase II and Phase III clinical trials, including Merck Serono's phase III CENTRIC trial, where only MGMT methylated patients are treated with the investigational drug cilengitide added to the current chemotherapy.

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 (100ng/m2 daily x 21d) in 1153 newly diagnosed glioblastoma (GBM) patients. Tumor tissue, obtained at the time of biopsy or surgery and with patient consent, was sent for central pathology review to confirm the tumor as a glioblastoma and as adequate to perform MGMT gene methylation analysis and molecular risk classification.

Upon pathology confirmation, eligible patients were randomized into one of two adjuvant treatment arms: Arm 1 (standard arm: TMZ days 1-5 every 28 days for up to 12 cycles/months) or Arm 2 (experimental arm: TMZ days 1-21 every 28 days for up to 12 cycles/months). Study participants were stratified to assess correlation of their outcome with three major criteria: (1) prognostic recursive partitioning (based upon age, performance status, extent of pretreatment surgery, neurologic function and mental status), (2) MGMT status (methylated, unmethylated, or indeterminate) and (3) radiation therapy treatment (US standard vs European). MGMT methylation was associated with improved overall survival (21.2, 14 mo, p < 0.0001), progression free survival (8.7, 5.7 mo, p < 0.0001) and response (p = 0.012). Cox modeling showed that MGMT status and RPA class were significant predictors of overall survival, while the treatment arm and radiation technique were not.

About the MGMT Test: PredictMDx for Brain TM
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.

Board of Director Changes
MDxHealth also announced that, per its June 2nd Board of Directors Meeting, Biovest CVA, represented by Mr Rudi Marien, has been appointed as director, in replacement of ING Belgium NV/SA, represented by Mr. Denis Biju-Duval, who resigned as per the same date. The Board thanks Mr. Biju-Duval for his many contributions since the inception of the company.

Rudi Mariën was co-founder, reference shareholder and Chairman of Innogenetics, and has been the founder, shareholder and Managing Director of several clinical reference laboratories. He was also the founder, shareholder and Managing Director of the Barc Group, a leading international centralized clinical laboratory, exclusively dedicated to pharmaceutical studies. Currently he is the Vice President of Cerba European Lab and President and Managing Director of Gengest Bvba and Biovest CVA. Through his management company, Gengest BVBA, Mr Mariën has board mandates in different publicly listed and private biotech companies.