MDxHealth announces publication of positive data from a blinded
multicenter clinical study demonstrating the utility of ConfirmMDx™ for
prostate cancer to address false-negative biopsies. Results of the study published in the Journal of Urology.
Full press release below
SOURCE: MDxHealth
IRVINE, CA, and LIEGE, BELGIUM--(Marketwire - Feb 11, 2013) - 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 the publication of results from a large clinical study on its
epigenetic ConfirmMDx™ for Prostate Cancer test in the March 2013 issue of Journal
of Urology. The results demonstrate the utility of the ConfirmMDx test as a
powerful tool to address well-documented concerns over false-negative biopsy
results.
The blinded, multicenter study named MATLOC (Methylation Analysis To
Locate Occult Cancer), was conducted at University of Edinburgh Urological
Cancer Group in the UK, the University Hospital of Liège, Belgium and the
Institut de Génétique et Pathologie in Gosselies, Belgium. The
investigators compared the performance of the ConfirmMDx assay to the current
standard of care for men with high-risk clinical factors for prostate cancer,
but negative biopsy results. Archived tissue samples from previous
negative biopsies of 483 men at high risk were tested with the ConfirmMDx
assay. The ConfirmMDx test results were then compared to the cancer
detection rate in the repeat biopsies conducted on the same patients within 30
months.
In a multivariate model, correcting for age, PSA, DRE and
histopathological characteristics of the first biopsy, the ConfirmMDx assay
proved to be the most significant, independent predictor of patient outcome
with an odds ratio of 3.17 (95% confidence interval: 1.81-5.53) along with
atypical cells in the first biopsy (3.17 odds ratio; 95% confidence interval:
1.31-7.70). The investigators report that ConfirmMDx accurately identified
64% of the prostate cancer-free men who could safely avoid a repeat biopsy with
a negative predictive value (NPV) of 90%. Importantly, the test also correctly
identified 68% of men who were harboring undetected prostate cancer at the time
of their previous histopathologically negative biopsy, many presenting with
clinically significant cancer upon repeat biopsy who would merit aggressive
treatment.
"Concerns over false-negative biopsy results are universally
shared by all urologists, especially when considering that the current standard
of care involving 12 needle biopsy tissue cores effectively samples less than
1% of a man's prostate. The MATLOC study demonstrates that the ConfirmMDx
for Prostate Cancer test can provide urologists with a critical tool to better
stratify patients at low risk of prostate cancer from those men at high risk
and to make more informed decisions on the need for repeat biopsy," said
Eric Wallen, MD, a practicing urologist at the Division of Urology and
Professor of Surgery at the University of North Carolina at Chapel Hill, who
serves as a consultant in the role of Chief Medical Officer for
MDxHealth. "As the cost of cancer continues to rise and challenge
healthcare budgets throughout the world, well-validated biomarkers like those
used in the ConfirmMDx test will play an increasingly important role in
improving patient care while reducing health care costs."
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
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 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 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.
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.
MATLOC ENG: http://hugin.info/137314/R/1676700/546713.pdf
Contact Information:
Contacts
Dr
Jan Groen,
CEO
MDxHealth
US: +1 949 812 6979
BE: +32 4 364 20 70
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
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