First epigenetic test to help identify men who may avoid repeat
IRVINE, Calif. & LIEGE, Belgium--(BUSINESS WIRE)--
SA (NYSE Euronext: MDXH), a leading molecular diagnostic company that
develops and commercializes epigenetic tests to support cancer
treatment, today announced the launch of ConfirmMDx?
for Prostate Cancer, a novel test that helps urologists distinguish
patients who have a true-negative prostate biopsy from those who may
have occult cancer. Testing will be performed in MDxHealth's
state-of-the-art Irvine-based CLIA laboratory for physicians submitting
prostate tissue samples directly or via its exclusive co-marketing
partner PLUS Diagnostics.
"As many as one in four men could be misdiagnosed due to limitations
with current prostate biopsy procedures, commonly described as ?sampling
error'. As a consequence, the standard of care for men with persistently
high-risk factors, but no evidence of prostate cancer in a biopsy, is
limited to continued surveillance and repeat biopsies, often on
prostate-cancer-free men. The ConfirmMDx for Prostate Cancer test
detects epigenetic changes associated with the presence or absence of
prostate cancer," explained Prof Dr. Wim van Crienkinge, Chief
Scientific Officer of MDxHealth.
"The launch of ConfirmMDx for Prostate Cancer represents the culmination
of extensive research and development efforts and demonstrates the
commitment of the MDxHealth team to deliver on its new commercial
strategy," said Dr. Jan Groen, CEO of MDxHealth. MDxHealth is uniquely
positioned with its portfolio of epigenetic assays to capitalize on the
realization of true personalized medicine, improving patient care, while
reducing healthcare costs."
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.
Please visit MDxHealth and PLUS Diagnostics at the American Urology
Association Annual Meeting, May 19-23 2012 in Atlanta, GA, booths #3831
MDxHealth is a molecular diagnostics company that develops and
commercializes advanced epigenetic tests for cancer assessment and the
personalized treatment of patients. By applying patented DNA methylation
platform and biomarkers, MDxHealth helps to address a large and growing
unmet medical need for better cancer diagnosis and treatment
information. 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 at the 13th annual
meeting BioEquity Europe that is taking place on May 15th-16th
in Frankfurt, Germany.
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
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or circumstances on which any such statement is based unless required by
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