MDxHealth Announces Results From the ConfirmMDx(TM) for Prostate Cancer Test Studies Presented at the 2013 ASCO Genitourinary

MDxHealth Announces Results From the ConfirmMDx(TM) for Prostate Cancer Test 
Studies Presented at the 2013 ASCO Genitourinary Cancers
Symposium 
IRVINE, CA, and LIEGE, BELGIUM -- (Marketwire) -- 02/18/13 -- 
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 results of two studies of the ConfirmMDx(TM) for
Prostate Cancer test presented at the ASCO Genitourinary Cancers
Symposium 2013, February 14-16, Orlando, Florida, USA.  
"These additional clinical studies add to our extensive body of
peer-reviewed evidence, clearly demonstrating the ability of
ConfirmMDx for Prostate Cancer test to provide valuable diagnostic
information to support urologists in better patient management," said
Jesse Savala, M.D., clinical pathologist and Medical Director at
MDxHealth. "With the advances being made in human epigenetics, we
believe that DNA methylation-based tests hold the promise to improve
the diagnosis and subsequent treatment of cancer patients."  
Studies clearly show that the ConfirmMDx(TM) for Prostate Cancer test
provides very important personalized information that cannot be
achieved with traditional procedures: 


 
--  In the Epigenetic Field Effect study in Histologically Benign Prostate
    Biopsy Cores it was shown that GSTP1, APC and/or RASSF1 gene promoter
    methylation is more prevalent in histologically benign cores from
    prostate cancer (PCa) patients diagnosed with Gleason Score (GS) 7
    PCa, as compared with low volume GS 6. This study confirms previous
    findings in a larger cohort of subjects that these "field effect"
    biomarkers can be useful for detecting cancer adjacent to
    histologically negative biopsies and may be indicative of occult
    aggressive PCa.
--  The multi-gene ConfirmMDx(TM) for Prostate Cancer test demonstrated
    that epigenetic profiling is a significant predictor for PCa risk,
    especially to identify those men who should (not) undergo a repeat
    biopsy following a negative initial biopsy. An integrated risk
    management approach that combines this epigenetic assay with other
    risk factors, most notably histopathologic features of the
    cancer
-negative initial biopsy, resulted in an improved prediction for
    the presence of PCa with sensitivity and negative predictive values of
    respectively 74% and 91%.

  
About ConfirmMDx for Prostate Cancer 
 Over 650,000 American men
receive a negative prostate biopsy result each year; though
approximately25% of these men may still harbor occult prostate
cancer. This well-documented risk of undetected cancer, often with
clinically significant disease 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" resulting from
oncogenic processes 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(TM) 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.  
ASCO SYMPOSIUM ENG : http://hugin.info/137314/R/1678617/547939.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 
 
 
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