MdxHealth (TM) : MDxHealth's ConfirmMDx(TM) Combined with PSA and Other Risk Factors, Improves Diagnosis of Prostate Cancer

 MdxHealth (TM) : MDxHealth's ConfirmMDx(TM) Combined with PSA and Other Risk
                Factors, Improves Diagnosis of Prostate Cancer




ConfirmMDx Highlighted in Presentation on New Biomarker Algorithm for Prostate
                        Cancer at 2013 AUA Conference

IRVINE, CA, and LIEGE,  BELGIUM - 8:00  AM, May 8, 2013  - MDxHealth SA  (NYSE 
Euronext: MDXH),  a leading  molecular diagnostic  company that  develops  and 
commercializes epigenetic tests to  support cancer treatment, today  announced 
that an  integrated risk  management approach  combining epigenetic  profiling 
using  the  ConfirmMDx   for  Prostate   Cancer  test,   combined  with   PSA, 
histopathological findings and other risk  factors, improves the detection  of 
prostate cancer, stratifying men at high  risk for prostate cancer from  those 
at low  risk who  may  forego a  repeat biopsy.  Data  were presented  at  the 
American Urology Association annual meeting in San Diego, USA.

The standard of care for screening has been PSA and DRE exam, however this has
generated a  great  deal of  controversy  within the  medical  community.  The 
American Urological Association  supports use  of PSA in  the appropriate  age 
group of men, despite the USPSTF  recommendation to restrict its use. One  of 
the biggest challenges with PSA screening is the high number of false-positive
test results leading to  prostate biopsies on men  suspected to have  prostate 
cancer. The majority of men will receive a negative biopsy result, however due
to sampling errors, cancer can  be missed in up to  25% of biopsied men.  This 
leads to uncertainty of diagnosis and a high rate of repeat biopsies.

"Results from  clinical  studies have  demonstrated  that the  ConfirmMDx  for 
Prostate Cancer  test can  help urologists  confirm negative  biopsy  results, 
reducing the need for  repeat biopsies, and ensure  men with positive  results 
are managed  appropriately," explained  Prof Wim  van Criekinge,  Head of  the 
Laboratory for Computational Genomics and Bioinformatics (Biobix),  University 
of  Ghent,  Belgium,  who  presented  the  data.  "These  studies  show   that 
integrating  multiple  traditional  risk  factors   with  this  type  of   DNA 
methylation profiling increases  the specificity of  testing. Ultimately  this 
could decrease the risk of misdiagnosis and improve patient management."

Study Details
Logistic regression models were used to evaluate a population of 391 men  with 
a first, prostate cancer-negative biopsy with a complete panel of risk factors
(age, PSA,  digital  rectal  examination, histopathology  and  the  epigenetic 
profile). All risk factors were  tested individually and in combinations.  The 
epigenetic profile was found  to be the  strongest individual predictor  (odds 
ratio (OR) = 3.46; p-value  < 0.001). The clinical  utility was optimal for  a 
model including the epigenetic  profile and the  histological findings of  the 
first biopsy, resulting in a sensitivity of  74%, a specificity of 63% and  an 
NPV of 91%.

Clinical Update on Novel Prostate Cancer Biomarkers
In a session at  the AUA conference titled  "Understanding How New  Biomarkers 
Will Assist  in  the Diagnosis  and  Prognosis of  Prostate  Cancer",  urology 
experts Dr. David Crawford  and Dr. Neal Shore  examined the clinical  utility 
and current  status of  new prostate  cancer biomarkers,  such as  MDxHealth's 
ConfirmMDx  for  Prostate  Cancer  and  Genomic  Health's  Oncotype  DX.  The 
discussion described how  these tests can  aid in the  improved detection  and 
treatment of prostate cancer.

The session provided  an overview  of the prostate  cancer diagnostic  pathway 
that included the role of biomarkers. In addition, a case study was  presented 
that highlighted the urologist's  dilemma when presented  with a patient  with 
elevated PSA and other high risk factors. MDxHealth's ConfirmMDx for  Prostate 
Cancer was  used to  highlight  how the  significant issue  of  false-negative 
biopsies can be addressed.

"When a prostate biopsy is performed for appropriate indications, there may be
concern that the  cancer may have  been missed, despite  the usual 10-14  core 
sampling. Tests which can improve the negative predictive value for a 1st time
biopsy  have  clinically  significant   benefit,  thus  potentially   avoiding 
unnecessary repeat biopsies," said Neal Shore, MD, FACS, CPI, Medical Director
at the Carolina Urologic Research  Center. "ConfirmMDx is a valuable  addition 
to our armamentarium and  addresses an unmet  need in diagnostic  evaluation. 
Many men  are subjected  to unnecessary  repeat biopsies,  with the  attendant 
morbidity and cost, as a result of an  elevated PSA as well as the concern  of 
missing  an  undetected  cancer.  ConfirmMDx  assists  in  the  avoidance  of 
unnecessary repeat biopsies."

The program  was supported  by the  Prostate Conditions  Education Council,  a 
consortium of leading  physicians, health educators,  scientists and  prostate 
cancer advocates.

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. 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,  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 and lung cancers. The company is based in Irvine,
California  with  a  European  headquarters   in  Liege,  Belgium.  For   more 
information visit MDxHealth's  website at www.mdxhealth.com  and follow us  on 
Twitter at: http://www.twitter.com/mdxhealth

For more information:

Dr Jan Groen          Mike Sinclair         Seth Lewis
President and CEO
MDxHealth             Halsin Partners       The Trout Group
US: +1 949 812 6979  UK: +44 20 7318 2955 US: +1 646 378 2952
BE: +32 4 364 20 70   Cell: +44 7968 022075
info@mdxhealth.com    msinclair@halsin.com  slewis@troutgroup.com



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