MDxHealth Announces Publication of Positive Data From a Blinded Multicenter Clinical Study Demonstrating the Utility of

MDxHealth Announces Publication of Positive Data From a Blinded Multicenter 
Clinical Study Demonstrating the Utility of
ConfirmMDx(TM) for Prostate Cancer to Address False-Negative Biopsies 
Results of the Study Published in the Journal of Urology 
IRVINE, CA, and LIEGE, BELGIUM -- (Marketwire) -- 02/11/13 -- 
MDxHealth SA (EURONEXT BRUSSELS: MDXH), a leading molecular
diagnostic company that develops and commercializes epigenetic tests
to support the diagnosis and treatment of cancer patients, today
announced the publication of results from a large clinical study on
its epigenetic ConfirmMDx(TM) for Prostate Cancer test in the March
2013 issue of Journal of Urology. The results demonstrate the utility
of the ConfirmMDx test as a powerful tool to address well-documented
concerns over false-negative biopsy results. 
The blinded, multicenter study named MATLOC (Methylation Analysis To
Locate Occult Cancer), was conducted at University of Edinburgh
Urological Cancer Group in the UK, the University Hospital of Liege,
Belgium and the Institut de Genetique et Pathologie in Gosselies,
Belgium. The investigators compared the performance of the ConfirmMDx
assay to the current standard of care for men with high-risk clinical
factors for prostate cancer, but negative biopsy results. Archived
tissue samples from previous negative biopsies of 483 men at high
risk were tested with the ConfirmMDx assay. The ConfirmMDx test
results were then compared to the cancer detection rate in the repeat
biopsies conducted on the same patients within 30 months. 
In a multivariate model, correcting for age, PSA, DRE and
histopathological characteristics of the first biopsy, the ConfirmMDx
assay proved to be the most significant, independent predictor of
patient outcome with an odds ratio of 3.17 (95% confidence interval:
1.81-5.53) along with atypical cells in the first biopsy (3.17 odds
ratio; 95% confidence interval: 1.31-7.70). The investigators report
that ConfirmMDx accurately identified 64% of the prostate cancer-free
men who could safely avoid a repeat biopsy with a negative predictive
value (NPV) of 90%. Importantly, the test also correctly identified
68% of men who were harboring undetected prostate cancer at the time
of their previous histopathologically negative
 biopsy, many
presenting with clinically significant cancer upon repeat biopsy who
would merit aggressive treatment. 
"Concerns over false-negative biopsy results are universally shared
by all urologists, especially when considering that the current
standard of care involving 12 needle biopsy tissue cores effectively
samples less than 1% of a man's prostate. The MATLOC study
demonstrates that the ConfirmMDx for Prostate Cancer test can provide
urologists with a critical tool to better stratify patients at low
risk of prostate cancer from those men at high risk and to make more
informed decisions on the need for repeat biopsy," said Eric Wallen,
MD, a practicing urologist at the Division of Urology and Professor
of Surgery at the University of North Carolina at Chapel Hill, who
serves as a consultant in the role of Chief Medical Officer for
MDxHealth. "As the cost of cancer continues to rise and challenge
healthcare budgets throughout the world, well-validated biomarkers
like those used in the ConfirmMDx test will play an increasingly
important role in improving patient care while reducing health care
costs." 
About ConfirmMDx for Prostate Cancer
 Over 650,000 American men
receive a negative prostate biopsy result each year; though
approximately 25% of these men may still harbor occult prostate
cancer. This well-documented risk of undetected cancer, often with
clinically significant Gleason scores, leads to a high rate of repeat
biopsies with over 40% of men receiving at least one repeat biopsy,
and many receiving a 3rd and 4th biopsy. Today's gold standard
diagnostic approach is the prostate biopsy procedure, collecting
10-12 needle core biopsy samples, however this sampling represents
less than 1% of a man's prostate. ConfirmMDx for Prostate Cancer is
an epigenetic assay to help urologists distinguish patients who have
a true-negative biopsy from those at risk for occult cancer. The test
is able to detect an epigenetic field effect or "halo" associated
with the cancerization process at the DNA level in cells adjacent to
cancer foci. This molecular "halo" around a cancer lesion can be
present despite having a normal appearance under the microscope. The
test helps urologists rule out prostate cancer-free men from
undergoing unnecessary repeat biopsies and helps rule in high-risk
patients who may require repeat biopsies and potential treatment.  
About MDxHealth
  MDxHealth is a molecular diagnostics company that
develops and commercializes advanced epigenetic tests for cancer
assessment and the personalized treatment of patients. The company's
first commercial product, the ConfirmMDx for Prostate Cancer test,
has been shown to help distinguish patients who have a true-negative
biopsy from those who may have occult cancer. MDxHealth helps to
address a large and growing unmet medical need for better cancer
diagnosis and treatment information. The company has a proprietary
platform and a strong epigenetic product pipeline focused on the
development of products for brain and lung cancers. The company is
based in Irvine, California with a European headquarters in Liege,
Belgium. For more information visit MDxHealth website at
www.mdxhealth.com. 
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. This
press release does not constitute an offer or invitation for the sale
or purchase of securities or assets of MDxHealth in any jurisdiction.
No securities of MDxHealth may be offered or sold within the United
States without registration under the U.S. Securities Act of 1933, as
amended, or in compliance with an exemption therefrom, and in
accordance with any applicable U.S. securities laws. 
NOTE: The MDxHealth logo, MDxHealth, ConfirmMDx and PredictMDx are
trademarks or registered trademarks of MDxHealth SA. All other
trademarks and service marks are the property of their respective
owners.  
MATLOC ENG: http://hugin.info/137314/R/1676700/546713.pdf  
Contacts  
Dr Jan Groen
CEO
MDxHealth
US: +1 949 812 6979
BE: +32 4 364 20 70
info@mdxhealth.com  
Mike Sinclair
Halsin Partners
UK: +44 20 7318 2955
Cell: +44 7968 022075
msinclair@halsin.com 
Seth Lewis
The Trout Group
US: +1 646 378 2952
---
slewis@troutgroup.com