MDxHealth Outlines New Strategy
(Thomson Reuters ONE) -
Focus on molecular diagnostic testing for personalized medicine in oncology
DURHAM, NC, and LIEGE, BELGIUM - October 19, 2010 - MDxHealth (NYSE Euronext:
MDXH), a leading molecular diagnostics company, formerly known as OncoMethylome
Sciences, today announced further details regarding its revised business
strategy. For the past several months, MDxHealth's management has worked very
closely with the Board of Directors to define a strategic path to accelerate
growth and monetization of the Company's proprietary DNA methylation platform.
MDxHealth will leverage its technologies to position itself at the forefront of
the burgeoning molecular diagnostics market, providing physicians with tools to
diagnose and better evaluate a patient's cancer.
Edward L. Erickson, Chairman of MDxHealth, said: "The Board of Directors is
excited about the Company's progress over the past five months. Under Dr. Jan
Groen's guidance, which combines long-term vision with a pragmatic, hands-on
approach, MDxHealth is now well-positioned for leadership in the field of
molecular cancer diagnostics, one of the fastest growing healthcare industry
segments."
The cornerstone of MDxHealth's new strategy is the development and
commercialization of high-value molecular diagnostic, prognostic, and predictive
tests, advancing personalized medicine for cancer patients. This new direction
will move MDxHealth away from its historical focus on discovery and out-
licensing of biomarkers for screening applications. The foundation of the new
strategy is to build a company that can determine its own fate, is less
dependent on priorities and timelines of licensing partners, and operates in a
space with high-end service products in terms of value creation, pricing, and
reimbursement. Management and the Board of Directors believe that this will
enable the Company to reap the benefits of its innovative methylation platform
by developing DNA-biomarkers as stand-alone diagnostic products. The Board is
confident that this new direction will create improved shareholder value in the
future and represents a more practical and expedient path for successful growth.
The role of DNA methylation patterns in carcinogenesis, and the full impact of
these patterns on clinical cancer practice have been gaining in importance over
the past five years. Rarely has a fundamental finding moved so expeditiously
from research to clinical diagnostic products and applications. While basic
research is continuing, the number of clinical studies and publications in the
field of methylation has risen exponentially. MDxHealth's unique and extensive
intellectual property portfolio in this field puts the Company in a strong
position to develop clinically meaningful cancer diagnostics expeditiously.
Specifically, MDxHealth will focus its efforts on the commercialization of
proprietary assays in three major cancers, namely prostate, colon, and lung
cancer. MDxHealth's DNA-methylation biomarkers, alone or in combination with
other methodologies, constitute very powerful tools to help address significant
unmet medical needs. These assays will help identify the presence of cancer
(diagnosis) assess the tumor aggressiveness and risk of cancer recurrence
(prognosis), and help stratify patients with respect to response to therapy
(prediction). The initial commercialization of these high-value tests will be
carried out in collaboration with established clinical laboratories with a
strong presence in the U.S. market.
Additionally, MDxHealth intends to expand its existing expertise and
capabilities by offering assay development, clinical trial, and companion
diagnostic test development services to pharmaceutical and major biotechnology
companies developing cancer therapeutics. The Company's biomarkers are well
suited to aid in stratification of patients, which can reduce drug development
costs, timelines, and increase efficacy by identifying those patients who are
most likely to respond to new therapies. MDxHealth has many promising companion
diagnostics biomarkers in brain, breast, lung, and colon cancer and has
partnered with companies such as Merck Serono and GlaxoSmithKline Biologicals.
Through 2011 the Company intends to focus its efforts on product development and
validation and the establishment of a US sales channel in the form of a service
offering via a CLIA licensed laboratory. Based on the current stage of
development, MDxHealth expects to focus first on the development and
commercialization of a molecular test for prostate cancer in the U.S. Results
from ongoing validation studies show excellent performance of MDxHealth's
prostate test compared to technologies and products currently on the market.
Next, the Company plans to launch a lung cancer recurrence assay for which data
has already been published in the New England Journal of Medicine. Lung cancer
represents a large underserved market, in which MDxHealth's methylation profiles
may have a positive impact. In addition, MDxHealth is developing a methylation
test to predict response to therapy in colorectal cancer. Furthermore, the
Company's first companion diagnostic test is currently in a Phase III FDA trial
with Merck Serono's drug cilengitide for brain cancer. MDxHealth has several
other co-development projects in place with pharmaceutical companies for the
development of companion diagnostic tests. The combined products of MDxHealth
will be addressing a market with a revenue potential of over $1 billion per
year.
To implement the new strategy MDxHealth has strengthened its management team and
Board of Directors. Following the appointment of Jan Groen, Ph.D., as Chief
Executive Officer to bring relevant development, commercial, operational and
U.S. experience, the Company has appointed Christopher Thibodeau as Vice
President Commercial Operations, Melissa Thompson as Vice President Regulatory
and Quality Affairs and, most recently, James Clark, Ph.D., as Vice President
Research & Development. All of these executives have a track record of over 15
years each in developing and commercializing innovative life science products
and diagnostics with leading companies such as US Labs-Esoterix (now a division
of LabCorp), Ventana Medical Systems (now a division of Roche), Johnson &
Johnson, Inverness, GlaxoSmithKline Biologicals, and Affymetrix. Furthermore,
several new, highly experienced independent directors have been appointed to the
Board of Directors, including Edward L. Erickson, Mark D. Myslinski, and Hilde
Windels, all of whom bring substantial management and diagnostic industry
operating experience to the Board, including experience in commercializing novel
cancer assays in both large and emerging companies and providing services
through CLIA licensed laboratories.
MDxHealth's updated website is operational as of today at www.mdxhealth.com.
About MDxHealth
MDxHealth is a leading molecular diagnostics company that develops and
commercializes diagnostic, prognostic, and predictive cancer tests. The
Company's tests are based on proprietary gene methylation technology and provide
physicians insights into the aggressiveness of their patients' cancer, the
likelihood of cancer recurrence, and can help predict a patient's response to
therapy. MDxHealth collaborates with leading cancer research centers such as
Johns Hopkins University and Duke University. The Company has a number of
commercial and collaborative partnerships with LabCorp, Merck & Co./Schering-
Plough, GlaxoSmithKline Biologicals, Millipore Corporation's BioScience
Division, Roche, Merck Serono and Qiagen.
For further inquiries:
Dr. Jan Groen Hans
Herklots
President & CEO
Capricorn One
Telephone +32 4 364 20 70
+41 79 598 7149
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.
[HUG#1452685]
2010-10-19 New strategy ENG:
http://hugin.info/137314/R/1452685/393403.pdf
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originality of the information contained therein.
Source: MdxHealth via Thomson Reuters ONE
Unternehmensinformation / Kurzprofil:
Datum: 19.10.2010 - 08:01 Uhr
Sprache: Deutsch
News-ID 45874
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