MDxHealth Licensee Exact Sciences Receives FDA Panel Recommendation for
Approval of Colorectal Cancer Screening Test
MDxHealth's Epigenetic Biomarker Used in Cologuard Test
IRVINE, CA, and HERSTAL, BELGIUM, March 28, 2014 (GLOBE NEWSWIRE) -- MDxHealth
SA (NYSE Euronext: MDXH), a leading molecular diagnostic company that develops
and commercializes epigenetic tests to improve the diagnosis and treatment of
cancer patients, today announced that the Molecular and Clinical Genetics
Panelof theUnited States Food and Drug Administration's (FDA) Medical
Devices Advisory Committee strongly endorsed approval of Cologuard(TM). The
Committee determined by a unanimous vote of 10 to zero that Exact Sciences has
demonstrated safety, effectiveness and a favorable risk benefit profile of
Cologuard, the company's stool-based DNA (sDNA), non-invasive colorectal
cancer screening test. Cologuard incorporates one of MDxHealth's epigenetic
biomarkers and methylation specific PCR (MSP) technology, which was licensed
to Exact Sciences in July 2010.
"Colorectal cancer is the second leading cause of cancer death inthe United
States yet often viewed as the most preventable," stated Dr. Jan Groen, CEO of
MDxHealth. "We are very proud to see that one of our epigenetic biomarkers is
a key component of the biomarker panel incorporated in the Cologuard screening
Cologuard is designed to detect specific changes in a patient's DNA that
appear in the stool, which could indicate the presence of colorectal cancer or
pre-cancerous polyps. The test also identifies the presence of blood in the
stool, another indicator of possible colorectal cancer.
"We are pleased the Committee strongly supported Cologuard's approval," said
Kevin T. Conroy, chairman and chief executive of Exact Sciences. "We look
forward to continuing our work with the FDA to complete its review of
Cologuard and remain committed to addressing the growing unmet needs in
colorectal cancer screening. We thank the FDA and its advisory committee for
its careful consideration of Cologuard. We also appreciate the opportunity to
participate in the innovative FDA/CMS parallel review program."
Cologuard is an investigational device currently under review by the U.S. Food
and Drug Administration (FDA) and is not available for sale in the United
States. The Committee's recommendation will be taken into consideration by
the FDA in its final review of the Cologuard test. The FDA is not bound by
the Committee's guidance but often follows this expert guidance.
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, ConfirmMDx^® for
Prostate Cancer, has been validated to help distinguish patients who have a
true-negative biopsy from those who may have undetected cancer, thereby aiding
in the reduction of unnecessary repeat biopsies. 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 prostate, brain,
bladder and lung cancers. For more information visit www.mdxhealth.com and
follow us on Twitter at:twitter.com/mdxhealth.
For more information:
Dr. Jan Groen, CEO Mike Sinclair Len Hall
MDxHealth Halsin Partners Allen & Caron, Inc
US: +1 949 812 6979 UK: +44 20 7318 2955 US: +1 949 474 4300
BE: +32 4 364 20 70 Cell: +44 7968 022075 email@example.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.
To access the PDF version, please click here
Press spacebar to pause and continue. Press esc to stop.