MdxHealth : MDxHealth Announces Publication of Positive Data from a Blinded Multicenter Clinical Study Demonstrating the Utility

 MdxHealth : MDxHealth Announces Publication of Positive Data from a Blinded
   Multicenter Clinical Study Demonstrating the Utility of ConfirmMDxTM for
              Prostate Cancer to Address False-negative Biopsies

Results of the Study Published in the Journal of Urology

IRVINE, CA,  and LIEGE,  BELGIUM -  February  11, 2013  - MDxHealth  SA  (NYSE 
Euronext: 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 Liège, Belgium and the Institut de
Génétique 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 3^rd and
4^th 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.

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

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

------------------------------------------------------------------------------

This announcement is distributed by Thomson Reuters on behalf of Thomson
Reuters clients.

The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and other
applicable laws; and
(ii) they are solely responsible for the content, accuracy and originality of
the
information contained therein.

Source: MdxHealth via Thomson Reuters ONE
HUG#1676700
 
Press spacebar to pause and continue. Press esc to stop.