MDxHealth Licensee Exact Sciences Receives FDA Panel Recommendation for Approval of Colorectal Cancer Screening Test

MDxHealth Licensee Exact Sciences Receives FDA Panel Recommendation for
Approval of Colorectal Cancer Screening Test

MDxHealth's Epigenetic Biomarker Used in Cologuard Test

IRVINE, CA, and HERSTAL, BELGIUM, March 28, 2014 (GLOBE NEWSWIRE) -- MDxHealth
SA (NYSE Euronext: MDXH), a leading molecular diagnostic company that develops
and commercializes epigenetic tests to improve the diagnosis and treatment of
cancer patients, today announced that the Molecular and Clinical Genetics
Panelof theUnited States Food and Drug Administration's (FDA) Medical
Devices Advisory Committee strongly endorsed approval of Cologuard(TM). The
Committee determined by a unanimous vote of 10 to zero that Exact Sciences has
demonstrated safety, effectiveness and a favorable risk benefit profile of
Cologuard, the company's stool-based DNA (sDNA), non-invasive colorectal
cancer screening test. Cologuard incorporates one of MDxHealth's epigenetic
biomarkers and methylation specific PCR (MSP) technology, which was licensed
to Exact Sciences in July 2010.

"Colorectal cancer is the second leading  cause of cancer death inthe  United 
States yet often viewed as the most preventable," stated Dr. Jan Groen, CEO of
MDxHealth. "We are very proud to see that one of our epigenetic biomarkers is
a key component of the biomarker panel incorporated in the Cologuard screening
test."

Cologuard is  designed to  detect specific  changes in  a patient's  DNA  that 
appear in the stool, which could indicate the presence of colorectal cancer or
pre-cancerous polyps. The test also identifies  the presence of blood in  the 
stool, another indicator of possible colorectal cancer.

"We are pleased the Committee  strongly supported Cologuard's approval,"  said 
Kevin T. Conroy,  chairman and chief  executive of Exact  Sciences. "We  look 
forward to  continuing  our  work with  the  FDA  to complete  its  review  of 
Cologuard and  remain  committed to  addressing  the growing  unmet  needs  in 
colorectal cancer screening. We thank the FDA and its advisory committee  for 
its careful consideration of Cologuard. We also appreciate the opportunity to
participate in the innovative FDA/CMS parallel review program."

Cologuard is an investigational device currently under review by the U.S. Food
and Drug Administration  (FDA) and  is not available  for sale  in the  United 
States. The Committee's  recommendation will be  taken into consideration  by 
the FDA in its final  review of the Cologuard test.  The FDA is not bound  by 
the Committee's guidance but often follows this expert guidance.

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,  ConfirmMDx^®  for 
Prostate Cancer, has been  validated to help distinguish  patients who have  a 
true-negative biopsy from those who may have undetected cancer, thereby aiding
in the reduction of unnecessary repeat biopsies. 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 prostate,  brain, 
bladder and lung  cancers. For more  information visit www.mdxhealth.com  and 
follow us on Twitter at:twitter.com/mdxhealth.

For more information: 

Dr. Jan Groen, CEO  Mike Sinclair         Len Hall
MDxHealth           Halsin Partners       Allen & Caron, Inc
US: +1 949 812 6979 UK: +44 20 7318 2955 US: +1 949 474 4300
BE: +32 4 364 20 70 Cell: +44 7968 022075 len@allencaron.com
info@mdxhealth.com  msinclair@halsin.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.

To access the PDF version, please click here
http://hugin.info/137314/R/1772409/603849.pdf

HUG#1772409
 
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