2013-02-18 08:16:49 -
IRVINE, CA, and LIEGE, BELGIUM - February 18, 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 the results of two studies of the ConfirmMDx(TM) for
Prostate Cancer test presented at the ASCO Genitourinary Cancers Symposium
2013, February 14-16, Orlando, Florida, USA.
"These additional clinical studies add to our extensive body of peer-reviewed
evidence, clearly demonstrating the ability of ConfirmMDx for Prostate Cancer
test to provide valuable diagnostic information to support urologists in better
patient management," said
Jesse Savala, M.D., clinical pathologist and Medical
Director at MDxHealth. "With the advances being made in human epigenetics, we
believe that DNA methylation-based tests hold the promise to improve the
diagnosis and subsequent treatment of cancer patients."
Studies clearly show that the ConfirmMDx(TM) for Prostate Cancer test provides
very important personalized information that cannot be achieved with traditional
procedures:
* In the Epigenetic Field Effect study in Histologically Benign Prostate
Biopsy Cores it was shown that GSTP1, APC and/or RASSF1 gene promoter
methylation is more prevalent in histologically benign cores from prostate
cancer (PCa) patients diagnosed with Gleason Score (GS) 7 PCa, as compared
with low volume GS 6. This study confirms previous findings in a larger
cohort of subjects that these "field effect" biomarkers can be useful for
detecting cancer adjacent to histologically negative biopsies and may be
indicative of occult aggressive PCa.
* The multi-gene ConfirmMDx(TM) for Prostate Cancer test demonstrated that
epigenetic profiling is a significant predictor for PCa risk, especially to
identify those men who should (not) undergo a repeat biopsy following a
negative initial biopsy. An integrated risk management approach that
combines this epigenetic assay with other risk factors, most notably
histopathologic features of the cancer-negative initial biopsy, resulted in
an improved prediction for the presence of PCa with sensitivity and negative
predictive values of respectively 74% and 91%.
About ConfirmMDx for Prostate Cancer
Over 650,000 American men receive a negative prostate biopsy result each year;
though approximately25% of these men may still harbor occult prostate cancer.
This well-documented risk of undetected cancer, often with clinically
significant disease 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" resulting from oncogenic processes 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. 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, the ConfirmMDx(TM) for
Prostate Cancer test, has been shown to help distinguish patients who have a
true-negative biopsy from those who may have occult 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 brain and
lung cancers. The company is based in Irvine, California with a European
headquarters in Liege, Belgium. For more information visit MDxHealth website at
www.mdxhealth.com.
Contacts
Dr Jan Groen, CEO
MDxHealth
US: +1 949 812 6979
BE: +32 4 364 20 70
info@mdxhealth.com
Mike Sinclair
Halsin Partners
UK: +44 20 7318 2955
Cell: +44 7968 022075
msinclair@halsin.com
Seth Lewis
The Trout Group
US: +1 646 378 2952
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.
ASCO SYMPOSIUM ENG:
hugin.info/137314/R/1678617/547939.pdf
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originality of the information contained therein.
Source: MdxHealth (TM) via Thomson Reuters ONE
[HUG#1678617]
