MdxHealth (TM) : MDxHealth Reports 2013 First-Half Results

          MdxHealth (TM) : MDxHealth Reports 2013 First-Half Results

Over 80% Increase in ConfirmMDx^TM for Prostate Cancer Test Volume From Q1 to
Q2 2013

IRVINE, CA, and LIEGE, BELGIUM, August 22, 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 its 2013 first half results.

Business Highlights
In  the  first  half   of  2013,  MDxHealth  continued   to  deliver  on   its 
commercialization plan for  ConfirmMDx for  Prostate Cancer in  the U.S.  That 
plan includes increasing the penetration of the test at an expanding number of
urology practices, while  advancing the clinical  and economic impact  studies 
necessary to  secure reimbursement  in line  with the  test's health  economic 
benefits.  During  the   first  half   of  2013,  test   volumes  ramped   up 
significantly, with 67 million lives added to the total number of patients who
can obtain  reimbursement for  the test.  More than  90 different  third-party 
insurance payers have reimbursed the ConfirmMDx test.

Data supporting the ConfirmMDx test  were published in peer-reviewed  journals 
and presented at major scientific conferences. The data demonstrated that the
biomarkers in the ConfirmMDx test outperform prostate specific antigen testing
(PSA) and  other  traditional  risk  factors  in  prostate  cancer  detection, 
representing a  powerful new  tool for  urologists assessing  the need  for  a 
repeat prostate  biopsy. Addtionally,  investigators  from the  University  of 
California at San Francisco and Thomas Jefferson University published a health
economic  study   in   the   journal   American   Health   &   Drug   Benefits 
(2013;6(1):15-24), which demonstrated that health insurance plans establishing
coverage  for  the   ConfirmMDx  for  Prostate   Cancer  test  would   realize 
approximately $600 in cost savings per patient managed, generating significant
economic benefits within the first year.

MDxHealth reported commercial and total revenues of €3.0 million in the  first 
half of  2013, a  51% increase  versus  the same  period in  2012.  Commercial 
revenues grew by 108%  over the first  half of 2012. There  were no grant  or 
subsidy revenues during the  first half of 2013.  The company's cash  position 
was significantly  improved through  an €18  million private  placement  which 
closed on June 25, 2013.

On June 7^th  MDxHealth partner  Exact Sciences (NASDAQ:  EXAS) submitted  the 
final module of  the premarket approval  (PMA) application for  Cologuard(TM), 
the company's molecular  stool-based colorectal cancer  screening test to  the 
U.S. Food and Drug Administration. Pending FDA approval Exact Sciences is  now 
preparing for  the  commercial launch  of  their test.  MDxHealth  expects  to 
receive milestone payments and royalties from the sale of the Cologuard test.

"Adoption of our ConfirmMDx for Prostate Cancer test in the U.S. continues  to 
accelerate. Year to  date we have  tested more than  42,000 prostate  biopsies 
from over 3,500  patients. This  represents a  sequential increase  of 82%  in 
volume in Q2 over Q1 2013," said Dr. Jan Groen, CEO of MDxHealth. "We continue
to build our commercialization  structure in the U.S.  to support this  growth 
through the remainder of 2013 and  beyond. Together with our partners, we  now 
have more than 70 sales representatives  in the U.S. promoting our  ConfirmMDx 
test for  Prostate Cancer  test, and  the penetration  rates are  being  aided 
further by the growing number of payers that have recognized the clinical  and 
economic value of the test and are reimbursing its use."

Commenting on the financial results, Dr. Groen continued: "We are pleased with
the significant growth in  commercial revenue thus far  in 2013, derived  from 
both diagnostic test and services sales. At this point more than 90  insurance 
companies have  recognized the  clinical utility  and economic  value and  are 
reimbursing the ConfirmMDx for Prostate Cancer test. Our managed care  efforts 
are focused on increasing coverage  through contracts with third-party  payors 
and networks.  Reimbursement codes  at these  insurers and  other  third-party 
payors allow MDxHealth to secure appropriatepayment, increase the  percentage 
of revenue  recognized, and  expedite  collections, while  providing  economic 
benefit to payers and the entire healthcare system." 

Key limited audited financials, as of June 30, 2013
Amounts as at and for the six months ended

Euro thousands               June 30, 2013 June 30, 2012
Commercial Revenues*                 3,033         1,456
Total Revenues                       3,033         2,014
EBITDA (Loss)                      (5,754)       (4,049)
EBIT Operating Income (Loss)       (5,953)       (4,260)
Net Profit (Loss)                  (5,971)       (4,259)
Cash and cash equivalents           24,677         6,551

*Commercial revenue is  defined as  revenue without government  grants and  or 
subsidies, and includes CLIA  laboratory diagnostic testing revenue,  services 
to pharmaceutical partners and royalty/licensing income.

Commercial revenue  in H1  2013  amounted to  €3.0  million compared  to  €1.5 
million in  H1 2012,  representing  an increase  of  108%. No  revenues  were 
derived from government grants  as the company continued  to focus on  growing 
its commercial revenue sources.

Test volumes for ConfirmMDx  for Prostate Cancer  continued to increase,  with 
more than  4,500  tests  sold to  date  since  launch. A  steady  increase  in 
reimbursement from private third-party payers was recorded during the  period, 
with more  than 90  insurers now  paying for  the test.  This is  expected  to 
increase further through the agreements with Multiplan and Three Rivers, which
plans have combined access to 67 million covered lives.

Operating Expenses
Operating expenses for 1H 2013 were  €7.6 million, increasing 24% compared  to 
€6.1 in 1H 2012.  As previously noted, this  increase was attributable to  the 
build-up of the U.S. operations in  support of ConfirmMDx for Prostate  Cancer 
test commercialization,  as well  as R&D  investment in  our pipeline  of  new 
diagnostic tests.

Non-operational and one-time restructuring costs, not expected to continue  in 
future periods, amounted to €302K for the period.

As expected, 1H 2013 loss increased over the same period in 2012 due to  costs 
associated with growing  commercial infrastructure to  support U.S. sales  and 
marketing and new product R&D investment. The company's operating loss  (EBIT) 
increased by 39.7%, and the net loss increased by 40.2% in H1 2013.

Cash Position
MDxHealth ended the first half of 2013 with cash and cash equivalents of €24.7
million compared to €6.6  million on June 30,  2012.The increase in cash  was 
supported in part by  the €18 million gross  private placement closed on  June 
25, 2013.

Based on the growth in the first two quarters of 2013 we anticipate continued
growth in test volumes, our customer base and payer reimbursement in coming

The  central  histopathology  review  of  the  company's  second   multicenter 
validation study for ConfirmMDx for  Prostate Cancer has completed. The  study 
involved five major cancer centers in the U.S. with Prof. Dr. Alan Partin from
Johns Hopkins University serving  as principle investigator. Testing  included 
3,687 archived prostate biopsy cores from 350 men in a blinded fashion. In the
coming weeks  the database  will be  unlocked and  data will  be analyzed  and 
submitted  for  an  oral  presentation  at  a  major  urology  conference  and 
publication in a leading urology journal. 

The development of MDxHealth's second  prostate cancer product (InformMDx)  is 
on target.  This  test  will provide  prognostic  assessment  to  distinguish 
between aggressive and non-aggressive prostate cancer. In Q1 2014 the  company 
will start validation studies for the test.

The reimbursement climate in the U.S. is still evolving. Along with our  peers 
in the industry, MDxHealth is closely monitoring the Centers for Medicare  and 
Medicaid Services'  (CMS)  changes to  the  Medicare Clinical  Laboratory  Fee 
Schedule. These fee schedule changes, coupled with the changing  reimbursement 
landscape, pose challenges for all diagnostic companies. While we believe the
lack of  clarity  is  a  temporary  situation,  we  have  elected  to  take  a 
conservative view  and will  likely adjust  our per  test revenue  projections 
downward to reflect the uncertainties.  Once payment histories under the  new 
codes are well established, we will reevaluate our revenue recognition  policy 
to determine if upward revision is appropriate.

The Company's revenue recognition  policy at this time  is primarily based  on 
cash collections.  Because  reported revenues  generally  exclude  uncollected 
outstanding billable  cases, the  impact  of current  test sales  on  reported 
revenues may be delayed by one or more calendar quarters. However, as  billing 
and reimbursement  trends are  established  with each  payer, the  Company  is 
transitioning to an  accrual-based revenue  recognition policy.  Additionally, 
MDxHealth has held claims  to Medicare and will  pursue payment once  Medicare 
has  reviewed  and  approved  the  company's  medical  dossier  and  finalizes 
reimbursement for the test, expected in 2013. Once Medicare reimbursement  is 
obtained, the company expects  a one time,  retrospective billing payment  for 
cases dating back to  2012, representing a significant,  one off, increase  in 
revenue.  We  anticipate   a  continued  increase   in  private   third-party 
reimbursement as  new payers  are included.  Currently, 70%  of all  MDxHealth 
ConfirmMDx cases are non-Medicare.

Total operating  costs  in the  second  half are  expected  to increase  in  a 
carefully controlled manner in line  with ramping up of the  commercialization 
activities associated with the ConfirmMDx for Prostate Cancer test.

Post-closing events
MDxHealth signed a partnership agreement with Bostwick Laboratories, a
full-service laboratory specializing in anatomic and clinical pathology, with
a focus on uropathology, providing MDxHealth with access to one of the largest
urology networks in the U.S.

In addition and  as noted  above, agreements  were signed  with MultiPlan  and 
Three Rivers  Provider  Network (TRPN)  to  provide expanded  access  for  the 
ConfirmMDx for Prostate  Cancer test. These  preferred provider  organizations 
(PPO's) contract with healthcare providers  typically on a discounted  fee-for 
service  basisin  circumstances  where  the  financial  risk  for  changesin 
utilization  of   medical  services   appears  limited   based  on   actuarial 
assumptions. PPOs andthird party administrators (TPA's) contract  withhealth 
maintenance organizations (HMO's), self funded employers, and other payers  to 
provide expanded choice, and services for patients, at discounted rates,  with 
seamless claims processing and claims optimization efficiencies.

The New York State  Department of Health (NYSDOH)  also certified and  granted 
approval for the ConfirmMDx for  Prostate Cancer test, completing  MDxHealth's 
list of state licensures, opening access to one of the largest markets in  the 

In  the   PharmacoMDx  business   area,   MDxHealth  established   a   service 
collaboration  with  HistoGeneX  to   provide  pharmaceutical  companies   and 
oncologists   with   integrated   molecular   diagnostic   testing   services. 
HistoGeneX's laboratory in Belgium will  also perform MGMT service testing  on 
behalf of MDxHealth's current and future clients.

In early July, MDxHealth signed a marketing partnership was signed with Summit
Pharmaceuticals International  Corporation  (SPI), a  subsidiary  of  Sumitomo 
Corporation,  to  gain  access  to   the  Japanese  market  with   MDxHealth's 
PharmacoMDx  services,  including   Next  Generation   sequencing  (NGS)   and 
epigenetic technologies and assays.

Statutory Auditor's Limited Review Report
We have reviewed the accompanying interim consolidated statement of  financial 
position of  MDxHealth  SA  as  of  30  June  2013  and  the  related  interim 
consolidated statements of  comprehensive income,  cash flows  and changes  in 
equity for the six-month period then ended, as well as the explanatory  notes. 
The Board of Directors is responsible for the preparation and presentation  of 
this consolidated  interim financial  information in  accordance with  IAS  34 
"Interim  Financial  Reporting",  as  adopted  by  the  European  Union.   Our 
responsibility is  to  express  a  conclusion  on  this  consolidated  interim 
financial information based on our review.

We conducted our review  in accordance with  International Standard on  Review 
Engagements 2410, "Review  of Interim Financial  Information Performed by  the 
Independent Auditor of the Entity". A review of interim financial  information 
consists of making inquiries, primarily  of persons responsible for  financial 
and accounting matters, and applying analytical and other review procedures. A
review is substantially less  in scope than an  audit conducted in  accordance 
with International Standards on Auditing  and consequently does not enable  us 
to obtain assurance that we would become aware of all significant matters that
might be  identified in  an audit.  Accordingly, we  do not  express an  audit 

Based on our  review, nothing  has come  to our  attention that  causes us  to 
believe that the  accompanying consolidated interim  financial information  is 
not prepared, in  all material respects,  in accordance with  IAS 34  "Interim 
Financial Reporting", as adopted by the European Union.

Zaventem, August 22, 2013

BDO Bedrijfsrevisoren Burg. Ven. CBVA / BDO Réviseurs d'Entreprises Soc. Civ.
Statutory auditor
Represented by Bert Kegels

Complete Financial Statements:
To download the 2013 interim report, go to:

About MDxHealth
MDxHealth is a molecular diagnostics company that develops and  commercializes 
advanced epigenetic tests for cancer assessment and the personalized treatment
of patients. By  applying patented DNA  methylation platform and  biomarkers, 
MDxHealth helps to address a large  and growing unmet medical need for  better 
cancer  diagnosis  and  treatment  information.  For  more  information  visit

For more information:

Dr. Jan Groen, CEO    Mike Sinclair          Matt Clawson
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     

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. Past performance  should 
not be relied upon as a predictor of future performance. 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.

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