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 - July 11, 2011 - 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.
 
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 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.
 
For more information:
 
 Dr. Jan Groen, CEO                       Hans Herklots
 
 MDxHealth                                Capricorn One
 
 +32 4 364 20 70                          +41 79 598 7149
 
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
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disclaims any obligation to update any such forward-looking statements in this
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2011-07-11 ENG: 
http://hugin.info/137314/R/1529781/465273.pdf
 
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Source: MdxHealth via Thomson Reuters ONE
 
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