Watch

Tweet TWEET

MDxHealth's PredictMDx for Glioblastoma Identifies Newly Diagnosed Patients with Improved Progression Free and Overall Survival

MDxHealth's PredictMDx for Glioblastoma Identifies Newly Diagnosed Patients
with Improved Progression Free and Overall Survival

Results of Phase III Trial for Bevacizumab (Avastin®) Published in the New
England Journal of Medicine

IRVINE, California, and HERSTAL, BELGIUM, March 4, 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 publication in the New
England Journal of Medicine of a phase III randomized trial of bevacizumab,
brand name Avastin^®, for newly diagnosed glioblastoma patients, confirms the
clinical utility of its PredictMDx^® for Glioblastoma test.

MDxHealth's PredictMDx  for Glioblastoma  (MGMT) test,  included in  the  2013 
National Comprehensive Cancer Network (NCCN) Senior Adult Oncology Guidelines,
provides actionable information to oncologists seeking to provide personalized
treatment of elderly  patients with  glioblastoma (GBM), the  most common  and 
most aggressive malignant primary brain tumor in humans. The test assesses the
methylation status of the MGMT gene, which  is a key DNA repair component.  If 
the MGMT gene is methylated, cancer  patients have shown improved response  to 
alkylating drug therapy. Studies on thousands of clinical trial patients have
demonstrated that PredictMDx  for Glioblastoma can  help oncologists  identify 
newly diagnosed glioblastoma patients that are  likely to respond to the  most 
commonly used class of brain cancer drugs (alkylating agents).

Dr Gilbert et al describe  the results of the  phase III study, "A  Randomized 
Trial of Bevacizumab  for Newly Diagnosed  Glioblastoma" (N Engl  J Med  2014; 
370:699-708,  February  20,  2014)   in  which  patients  were   prospectively 
randomized   into   the   treatment    arms   based   on   MDxHealth's    MGMT 
(O6-methylguanine-DNA  methyl  transferase)  methylation  test  results.  MGMT 
methylation status was  shown to be  prognostic for progression-free  survival 
(PFS) and overall survival (OS), regardless of therapies investigated in  this 
study. The median PFS  for patients with unmethylated  tumors was 8.2  months 
vs. 14.1 months  in the patients  with MGMT methylated  tumors, with a  hazard 
ratio of 1.67 (95% CI of 1.36  to 2.05, p<0.001). The median OS for  patients 
with MGMT unmethylated  tumors was 14.3  months compared with  23.2 months  in 
patients with MGMT methylated tumors. The hazard ratio for death in  patients 
with unmethylated  tumors  was reported  as  2.10 (95%  CI  of 1.65  to  2.68, 
p<0.001).

"As shown  in  previous published  studies  these results  again  confirm  the 
prognostic value  of  our  PredictMDx  test  in  glioblastoma.  These  results 
demonstrate the clinical importance of using molecular biomarkers, like  MGMT, 
to improve patient stratification  and the current  standard of care,"  stated 
Prof. Dr. Wim van Criekinge, Chief Scientific Officer of MDxHealth.

About MDxHealth ^®

MDxHealth (formerly OncoMethylome Sciences) 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 (media)  Len Hall (investors)
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/1765948/599470.pdf

HUG#1765948
 
Press spacebar to pause and continue. Press esc to stop.