MDxHealth Announces Publication of Health Economic Analysis Demonstrating Cost-Savings of ConfirmMDx for Prostate Cancer
Budget Impact Model: Epigenetic Assay Can Help Avoid Unnecessary Repeated
Prostate Biopsies and Reduce Healthcare Spending
IRVINE, CA, and LIEGE, BELGIUM - February 14, 2013 - MDxHealth SA (NYSE
Euronext: MDXH), a leading molecular diagnostic company that develops and
commercializes epigenetic tests to support cancer diagnosis and treatment, today
announced the publication of results from a health economic study in the Journal
of American Health & Drug Benefits. The budget impact analysis demonstrated
achievable cost savings of MDxHealth's ConfirmMDx(TM) for Prostate Cancer test,
which is used by urologists to identify men who may avoid unnecessary repeat
prostate biopsies, thereby reducing overall healthcare spending.
The analysis projected the benefits, costs, and cost savings of the ConfirmMDx
for Prostate Cancer test based on empirical evidence of its clinical
effectiveness compared to a standard of care reference scenario not using the
assay. The goal was to quantify the impact on costs by avoiding medically
unnecessary repeat prostate biopsy procedures for a managed care plan of one
million members that reimburses for the ConfirmMDx for Prostate Cancer test. A
budget impact model was built to test the hypothesis that the ConfirmMDx for
Prostate Cancer test can produce cost savings to payers as well as benefits to
urologists and patients by providing actionable guidance to treat with more
appropriate and less costly care.
The analysis demonstrated that a commercial health plan would realize cost
savings within the first year of establishing coverage for the ConfirmMDx for
Prostate Cancer test. The upfront cost will be recovered based on the savings
associated with avoided biopsy procedures and associated complications. Given
these assumptions and the costs associated with the current standard of care,
the inclusion of the test into the management of men screened for prostate
cancer  resulted in a net cost savings of $588.00 per patient or budget impact
of   in a managed care plan of one million members.
"Even with conservative assumptions, our budget impact analysis demonstrates
that the ConfirmMDx for Prostate Cancer test can provide economic returns that
may generate net cost savings to health plans by reducing unnecessary prostate
biopsies, thus improving clinical management and patient outcomes," said lead
author Wade Aubry, M.D., Senior Medical Director for Quorum Consulting and
Associate Clinical Professor of Medicine at the  University of California, San
Francisco. "ConfirmMDx demonstrates the exciting potential of personalized
medicine. In today's cost-conscious healthcare environment, well-validated
molecular tests hold the promise to address not only unmet clinical needs, but
also provide health economic benefits."
About Prostate Cancer
Prostate cancer is the most frequent cancer in men worldwide, with one out of
six men being diagnosed with prostate cancer in a lifetime. In the United States
approximately 19 million men are screened with the PSA test on an annual basis,
leading to more than 1.3 million biopsy procedures and about 240,890 newly
diagnosed cases.
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 the volume of a man's prostate gland. 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
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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.
HEALTH ECONOMIC ENG:
http://hugin.info/137314/R/1677896/547398.pdf
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Source: MdxHealth (TM) via Thomson Reuters ONE
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