MDxHealth's Prostate Cancer Test Approved by New York State Department of Health

MDxHealth's Prostate Cancer Test Approved by New York State Department of Health 
IRVINE, CA and LIEGE, BELGIUM -- (Marketwired) -- 07/10/13 -- 
MDxHealth SA (EURONEXT BRUSSELS: MDXH), a leading molecular
diagnostic company that develops and commercializes epigenetic tests
to support the diagnosis and treatment of cancer patients, today
announced that the New York State Department of Health (NYSDOH) has
certified and granted approval for the ConfirmMDx(TM) for Prostate
Cancer test. This approval by NYSDOH completes MDxHealth's list of
state licensures, allowing the Company to offer the test in all 50
states. The ConfirmMDx for Prostate Cancer test is performed on
tissue obtained from a previous negative prostate biopsy to help
distinguish patients who have a true-negative result and may forego
an unnecessary repeat biopsy from those at high risk for missed
"The NYSDOH approval of the ConfirmMDx for Prostate Cancer test is a
major milestone for MDxHealth. The Department's independent
technology assessment for laboratory developed tests, which are also
regulated at the federal level, is widely regarded as the most
rigorous review process due to stringent quality standards. With the
New York State approval and clinical laboratory license, ConfirmMDx
for Prostate Cancer is now available to patients and urologists
throughout the U.S. This licensure opens one of our largest potential
domestic markets within the U.S., with an estimated 65,000 prostate
biopsy procedures performed annually." said Dr. Jan Groen,
MDxHealth's CEO. "The NYSDOH approval completes our state licensing
requirements and allows us to fully execute on our U.S.
commercialization strategy for this clinically significant prostate
cancer test."  
About ConfirmMDx for Prostate Cancer 
 Over 975,000 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 greater than 40% of men receiving at least one repeat
biopsy, and many receiving a 3rd and 4th 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 rule in high-risk patients who may require repeat
biopsies and potential treatment. 
About MDxHealth(R) 
 MDxHealth is a molecular diagnostics company
that develops and commercializes advanced epigenetic tests for cancer
assessment and the personalized treatment of patients. 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 
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
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depend upon factors that are beyond the company's control, and may
turn out to be materially different. MDxHealth expressly disclaims
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No securities of MDxHealth may be offered or sold within the United
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amended, or in compliance with an exemption therefrom, and in
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NOTE: The MDxHealth logo, MDxHealth, MDxHealth Laboratories of
California, ConfirmMDx and PredictMDx are trademarks or registered
trademarks of MDxHealth SA. All other trademarks and service marks
are the property of their respective owners. The Company offers its
services within the State of New York as MDxHealth Laboratories of
California (dba). 
To access the PDF version, click here : 
For more information: 
Dr. Jan Groen
US: +1 949 812 6979
BE: +32 4 364 20 70  
Mike Sinclair
Halsin Partners
UK: +44 20 7318 2955
Cell: +44 7968 022075 
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