2013-02-11 08:14:08 -
Results of the Study Published in the Journal of Urology
IRVINE, CA, and LIEGE, BELGIUM - February 11, 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 publication of results from a large clinical study
on its epigenetic ConfirmMDx(TM) 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 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" 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.
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
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