MDxHealth's ConfirmMDx(TM) for Prostate Cancer Test Helps to ...

IRVINE, Calif. LIEGE, Belgium, May 23, 2012 (BUSINESS WIRE) ?
Regulatory News:

MDxHealth
SA (nyse euronext:MDXH), a leading molecular diagnostic company that
develops and commercializes epigenetic tests to support cancer
treatment, today announced it has presented data demonstrating that its
epigenetic ConfirmMDx(TM) for Prostate Cancer test can aid urologists in
identifying patients who may avoid a repeat prostate biopsy.

In men suspected to have prostate cancer, the potential for
false-negative biopsy results is well documented in the literature.
Approximately twenty-five percent of men receiving a negative
histopathology result, the gold standard for diagnosis, could be
harboring occult cancer. Fear over this issue leads to additional
physician visits, screening, and repeat biopsies, often on
prostate-cancer-free men. MDxHealth?s ConfirmMDx test assesses the DNA
methylation status of genes associated with prostate cancer. The test
will help urologists differentiate patients with a true-negative biopsy
from those who may have cancer undetected by prostate biopsy and
histopathological review.

The data from the MATLOC (Methylation Analysis To Locate Occult Cancer)
study presented during the Late Breaking Science Forum yesterday at the
American Urology Association (AUA) Annual meeting in Atlanta, USA,
revealed that the ConfirmMDx for Prostate Cancer test is a powerful tool
to aid urologists in addressing false-negative biopsy concerns.

?With a high negative predictive value, exceeding that of standard
microscopic histopathology review, the MATLOC study results demonstrate
that the ConfirmMDx for Prostate Cancer test can help urologists confirm
true-negative biopsy results, providing peace-of-mind and reducing
unnecessary repeat biopsies,? explained principle investigator Dr. Grant
Stewart from the Edinburgh Urological Cancer Group at the University of
Edinburgh, who presented the data. ?The test will also help urologists
identify high-risk men who may have occult cancer, enabling more
effective triage of these patients with a repeat biopsy and treatment as
required.?

?These data confirm the high negative predictive value (NPV) and
clinical utility of the ConfirmMDx for Prostate Cancer genes and DNA
methylation technology previously reported in published studies. We
believe the test fulfills an unmet medical need, complementing the
current standard of care, and holds the potential to reduce unnecessary
invasive procedures and the associated healthcare expenditures. Prostate
biopsies pose significant risk of trauma and infection, at times
requiring hospitalization. As a consequence, approximately one-third of
men refuse to endure a repeat biopsy despite fear of a false-negative
result, leaving these men at risk for disease progression. ConfirmMDx, a
non-invasive assay performed on the residual prostate tissues from the
previous negative biopsy, provides critical insights beyond
histopathology to enable more informed patient management decisions,?
said Dr. Jan Groen, CEO of MDxHealth. ?We are pleased to announce that
ConfirmMDx for Prostate Cancer is now available to urologists directly
through MDxHealth?s state-of-the-art CLIA laboratory, and via our
co-marketing partner PLUS Diagnostics.?

Study Details

The multicenter MATLOC study involved 3 sites from the UK and Belgium,
testing tissue from initial negative biopsies and comparing assay
results to cancer detection in subsequent biopsies within 30 months
revealing either cancer (cases) or negative results (controls).
Individual prostate biopsies comprised 10 separate tissue cores on
average. ConfirmMDx for Prostate Cancer was used to analyze the
methylation status of a panel of validated biomarkers (GSTP1, APC
and RASSF1) in 4,681 archived prostate biopsy cores from 483 men
in a blinded fashion. Results demonstrated that the assay had a NPV of
90%

Application of this assay to initial, negative prostate biopsies
accurately identified over two-thirds of patients who had cancer
detected on a subsequent prostate biopsy, while correctly confirming
negative findings in approximately two-thirds of men who were
cancer-free in a subsequent prostate biopsy. The high NPV of 90%
indicates this assay could help avoid unnecessary repeat prostate
biopsies.

Approximately 60% of positive assay results were indicated by one
methylated gene while the remaining 40% of cases displayed two or more
methylated genes. Univariate analyses identified that the methylation
panel was a significant predictor of prostate cancer diagnosis. These
findings were confirmed with a multivariate logistic regression,
correcting for PSA, age, digital rectal examination results prior to
initial biopsy and histopathological findings of this biopsy.

The study entitled ?Clinical utility of a multiplexed epigenetic gene
assay to detect cancer in histopathologically negative prostate
biopsies: results of the multicenter MATLOC study?, was presented by
Dr. Grant Stewart from the Edinburgh Urological Cancer Group at the
University of Edinburgh, on Tuesday, May 22, 2012 during the late
breaking science session. Abstracts from the conference are available
online.

About
ConfirmMDx for Prostate Cancer

Over 650,000 American men receive a negative prostate biopsy result each
year; however approximately 25-35% of these results are false negative.
Under the current standard of care, prostate biopsy procedures collect
10-12 needle biopsy cores on average, effectively sampling less than 1%
of a man?s prostate. This approach leaves men at risk of occult cancer,
leading to a high rate of repeat biopsies, often on prostate-cancer-free
men. There is an unmet medical need for a clinically effective
diagnostic test to address this dilemma. ConfirmMDx for Prostate Cancer
is an epigenetic assay to help distinguish patients who have a
true-negative biopsy from those at risk for occult cancer. 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. The test is able to
detect an epigenetic field effect or ?halo? associated with the
cancerization process at the DNA level in cells adjacent to cancer foci.
This molecular ?halo? around a cancer lesion can be present despite
having a normal appearance under the microscope. Thus ConfirmMDx for
Prostate Cancer aids urologists in identifying men who may forego
unnecessary repeat biopsies.

About MDxHealth

MDxHealth is a leading molecular diagnostics company that develops and
commercializes epigenetic tests to support cancer treatment. The
company?s tests are based on proprietary gene methylation (epigenetics)
technology and assist physicians with the diagnosis of cancer, prognosis
of recurrence risk, and prediction of response to a specific therapy.
For more information visit

http://www.mdxhealth.com

and follow us on Twitter at:
http://www.twitter.com/mdxhealth .

Dr. Jan Groen will present on MDxHealth on June 19th at 9:30
at the 2012 BioInternational Convention that is taking place in Boston
(June 18-21).

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.

SOURCE: MDxHealth SA

          MDxHealth         Dr. Jan Groen, CEO         US: +1 949 812 6979         BE: +32 4 364 20 70         info@mdxhealth.com         or         Halsin Partners         Mike Sinclair         UK: +44 20 7318 2955         Cell: +44 7968 022075         msinclair@halsin.com 

Copyright Business Wire 2012

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