MdxHealth (TM) : MDxHealth Epigenetic Marker as Companion Diagnostic for Irinotecan based Therapy in Colorectal Cancer

   MdxHealth (TM) : MDxHealth Epigenetic Marker as Companion Diagnostic for
                Irinotecan based Therapy in Colorectal Cancer

                            Data Presented at ASCO

IRVINE, CA, and LIEGE, BELGIUM  - 8:00 AM, June 3,  2013 - MDxHealth SA  (NYSE 
Euronext: MDXH),  a leading  molecular diagnostic  company that  develops  and 
commercializes epigenetic tests to  support cancer treatment, today  announced 
data showing that  methylation of the  Decoy Receptor 1  (DCR1) gene may  help 
guide oncologists in selecting metastatic colorectal cancer (CRC) patients  to 
receive irinotecanbased therapy. The data, presented on June 2^nd at the 49th
Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago,
USA, showed that CRC  patients with methylated DCR1  did not benefit from  the 
addition of irinotecan to capecitabine therapy.

Identification of DCR1 as a novel hypermethylated gene associated with a  lack 
of benefit  in  adding irinotecan  to  capecitabine when  treating  metastatic 
colorectal cancer was performed  in the pathology  department of Prof.  Gerrit 
Meijer (VUmc, Amsterdam) as part of the CTMM public-private partnership DeCoDe
(Decrease Colorectal Cancer Death) project. Commenting on the discovery, Prof.
Gerrit Meijer  said "As  part of  a concerted  effort to  reduce the  enormous 
impact of  colorectal  cancer  on  patients and  healthcare  systems,  all  14 
partners in  the  DeCoDe project  have  worked tirelessly  to  identify  novel 
biomarkers that will aid in the diagnosis and treatment of the disease."

Prof. Wim  Van  Criekinge,  CSO  at  MDxHealth  added,  "Predictive  molecular 
biomarkers can help guide the selection of patients that are likely to respond
to a  given treatment,  or in  the case  of DCR1,  identify patients  who  are 
unlikely to  respond  to  specific therapy,  potentially  sparing  unnecessary 
toxicity and  allowing treatment  with more  effective, alternative  therapies 

"The innovative use  of advanced bioinformatics,  combined with several  Next 
Generation molecular profiling  methods, and  integrated with  pharmacological 
data is  one the  key missions  of  NXTGNT and  enables the  highly  efficient 
identification of specific predictive biomarkers, such as DCR1," stated  Prof. 
Dieter Deforce,  Head of  the Laboratory  of Pharmaceutical  Biotechnology  at 
NXTGNT  Center  in  Pharmaco  (Epi)genomics,  a  joint  collaboration  between 
MDxHealth and the Ghent University.

Study Details
The presence of DNA methylation for a selected panel of 22 genes was  assessed 
on primary tumors of 185 patients  with metastatic CRC treated with  firstline 
capecitabine (CAP,  n=90)  or a  combination  of capecitabine  and  irinotecan 
(CAPIRI, n=95) in the phase 3 CAIRO trial. Methylation status of each gene was
correlated to progression free survival (PFS) by treatment regimen. Genes  for 
which methylation  status  was associated  with  response to  irinotecan  were 
validated in 166 patients treated with firstline CAP (n=78) or CAPIRI  (n=88). 
In CAPIRI treated patients, DCR1 methylation  was correlated to a shorter  PFS 
compared to  patients  with unmethylated  DCR1  (hazard ratio  [HR]=0.4,  p  = 
0.0009). In patients  with methylated  DCR1 PFS  did not  improve with  CAPIRI 
treatment, compared  to  treatment  with CAP  (discovery  set:  HR=0.8  p=0.4; 
validation set: HR=1.1, p=0.6, in contrast to patients with unmethylated  DCR1 
(discovery set: HR=2.5, p=0.00004; validation set: HR=1.7, p=0.004).

About CTMM
The CTMM (Center for Translational Molecular Medicine) is a  Netherlands-based 
public-private partnership. It is dedicated to the development of technologies
in molecular medicine that enable  early diagnosis and personalized  treatment 
for main areas of disease causing mortality and diminished quality of life  in 
the western world. Focus  lies on oncology, cardiovascular,  neurodegenerative 
and infectious/auto-immune disease. CTMM operates by inviting, assessing,  and 
funding  multidisciplinary  projects  that  involve  active  participation  by 
Netherlands-based academia and industry.  All CTMM projects  are judged by  an 
independent International Advisory Board and  approved by a Supervisory  Board 
based on  their significant  potential to  translate research  knowledge  into 
clinical practice. The CTMM is funded by the Dutch government (50%),  academia 
(25%) and  industry  (25%).  Additional  funding  is  provided  by  supporting 
foundations on behalf of patients. 

DeCoDe (Decrease Colorectal Cancer Death) is one of the CTMM projects, with 14
partners and a project budget of 18.6 M Euro. Key figures CTMM: 119  partners, 
M€ 302.7  allocated  budget until  the  end of  2015,  22  projects/consortia,

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^TM  for 
Prostate Cancer,  has been  shown  to help  distinguish  patients who  have  a 
true-negative biopsy  from those  who may  have undetected  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 prostate, brain, lung and colon cancers. The company is based  in 
Irvine, California with a  European headquarters in  Liege, Belgium. For  more 
information visit MDxHealth's website at

For more information: Mike Sinclair          Seth Lewis
Dr. Jan Groen, CEO    Halsin Partners        The Trout Group
MDxHealth             UK: +44 20 7318 2955
US: +1 949 812 6979   Cell: +44 7968 022075  US: +1 646 378 2952
BE: +32 4 364 20 70 

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


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
information contained therein.

Source: MdxHealth (TM) via Thomson Reuters ONE
Press spacebar to pause and continue. Press esc to stop.