MdxHealth (TM) : MDxHealth Provides First Quarter 2013 Business Update

    MdxHealth (TM) : MDxHealth Provides First Quarter 2013 Business Update

   

Revenue increases 51% over first quarter 2012

IRVINE, CA, and LIEGE, BELGIUM  - May 7, 2013  - MDxHealth SA (NYSE  Euronext: 
MDXH), a leading molecular diagnostic company that develops and commercializes
epigenetic tests to support cancer treatment, today issued its business update
for the quarter ended March 31, 2013.

"In Q1 2013, we recorded considerable growth in the sales of our ConfirmMDx^TM
for Prostate Cancer test. At  the time of this  release, we have surpassed  a 
key milestone of 1,500  ConfirmMDx tests sold this  year, exceeding the  total 
number of tests sold  in 2012. We experienced  an increased rate of  adoption 
within the urology community,  adding new clients  and further establishing  a 
solid base of repeat clients,  with nearly 400 urologists ordering  ConfirmMDx 
to date," said Dr. Jan Groen, CEO of MDxHealth. "We are extremely pleased with
the growing momentum of our commercialization efforts, augmented by the recent
expansion of the sales  force and the publication  of our clinical  validation 
study in the Journal  of Urology earlier this  year. We believe the  increased 
awareness of ConfirmMDx among urologists will result in continued adoption  by 
the urology community and drive positive coverage decisions by payors."

Q1 2013 Highlights

During Q1  2013, adoption  of  the ConfirmMDx(TM)  for Prostate  Cancer  test, 
launched in  May 2012,  continued to  grow, as  reflected in  the  significant 
increase in revenues  during the  period. Revenues  in Q1  2013 increased  51% 
compared to the  same period  in 2012, with  total revenues  of €1.1  million. 
Reported  revenue  in  Q1  2013  was  obtained  exclusively  from   commercial 
activities. As of  March 31, 2013,  the company  had €9.5 million  of cash  on 
hand.

In Q1  2013, MDxHealth  published two  prostate cancer  scientific papers  and 
presented two studies at the February ASCO Genitourinary Cancers symposium  in 
Orlando,  Florida,  USA.  Both   the  scientific  publications  and   studies 
demonstrated that the biomarkers  in the ConfirmMDx test  outperform PSA in  a 
prostate cancer detection algorithm and as an aide to the decision to  proceed 
for a repeat  prostate biopsy. The  company also published  a health  economic 
study in the Journal  of American Health &  Drug Benefits, which  demonstrates 
that a  commercial insurance  plan would  realize approximately  $600 in  cost 
savings per patient  within the first  year of establishing  coverage for  the 
ConfirmMDx for Prostate Cancer test.

During the quarter, Merck KGaA reported that its Phase III clinical study with
cilengitide  in  newly  diagnosed  glioblastoma  did  not  meet  its   primary 
endpoints. As a result the service  agreement regarding MGMT testing for  this 
particular project with Merck KGaA ended.

Events after the Reporting Period

On April 18,  2013, MDxHealth  partner Exact Sciences  reported top-Line  data 
from the clinical trial of their Cologuard colorectal cancer screening test, a
non-invasive, convenient DNA-based  screening test for  colorectal cancer  and 
pre-cancerous polyps. Data from the 10,000-patient, DeeP-C clinical trial show
that all endpoints were achieved, with  sensitivity of 92% and specificity  of 
87% for the  detection of  colorectal cancer.  Exact Sciences  is expected  to 
submit data from the DeeP-C study to the U.S. Food and Drug Administration  as 
part of  its pre-market  approval  (PMA) submission.  Later this  year,  Exact 
Sciences is  also  expected  to  submit the  study's  complete  data  set  for 
publication in a peer-reviewed  journal, for presentation  at a major  medical 
meeting, or both.  Exact Sciences intends  to sell this  test through its  own 
CLIA  service  laboratory  in  Madison,  Wisconsin.  MDxHealth  will   receive 
milestone payments and royalties from the sale of the Cologuard test.

In April,  MDxHealth's Irvine-based  CLIA certified  and College  of  American 
Pathologists  (CAP)  accredited   laboratory  also   received  ISO   9001:2008 
certification from DEKRA Certification, Inc., Chalfont, PA.

Key non-audited financials, as of March 31, 2013

Amounts in Euro's as at or for the three months ended

Euro thousands               March 31, 2013 YTD March 31,2012 YTD
Revenues                           1,083               719
EBITDA Income (Loss)              (2,838)            (1,842)
EBIT Operating Income (Loss)      (2,906)            (1,953)
Net Profit (Loss)                 (2,905)            (1,920)
Cash and cash equivalents          9,467              9,557

Q1 2013 commercial product and service revenue was €1.1 million, growing  51% 
over Q1 of 2012. None of the revenue was obtained from grants, compared to  Q1 
2012 which had €137K in revenue from  grants. Overall spending in Q1 was  €4.0 
million, up  €1.4 million  over the  same period  last year.  The increase  in 
overall expense  was  primarily due  to  planned expansion  of  the  company's 
commercial operations to accelerate the  sales of the ConfirmMDx for  Prostate 
Cancer test.  First quarter  operating  loss (EBIT)  and  net loss  were  €2.9 
million, an increased  loss of €953K  and €985K, respectively,  over the  same 
period in 2012. The Company's cash and  cash equivalents as at March 31,  2013 
was €9.5 million.  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  payor, 
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.

Q2 and FY2013 Outlook

MDxHealth will  continue  executing  its commercialization  strategy  for  the 
ConfirmMDx for Prostate Cancer  test by establishing  new sales and  marketing 
agreements within  and outside  the U.S.  Operating expenses  are expected  to 
increase primarily from this expansion of  our commercial efforts in the  U.S. 
The Company expects total revenue to grow significantly in Q2 over Q1 and to
show year-over-year growth for FY2013. This guidance is based on management's
assessment of  growth,  including  anticipation  of  increased  sales  of  the 
ConfirmMDx for Prostate  Cancer test and  from new PharmacoMDx  opportunities. 
MDxHealth also expects to receive a license for its CLIA laboratory from  the 
State of New York before the end of Q3, 2013.

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 prostate 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

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.

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Source: MdxHealth (TM) via Thomson Reuters ONE
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