MDxHealth's biomarker part of large pivotal colon cancer trial initiated by Exact Sciences

Mittwoch, 03.08.2011 08:05 von Hugin - Aufrufe: 256

DURHAM,  NC, and LIEGE, BELGIUM -  August 3, 2011 - MDxHealth SA (NYSE Euronext:
MDXH), a leading molecular diagnostics company in the field of personalized
medicine, announced today that its licensing partner Exact Sciences Corp.
(Nasdaq: EXAS) has initiated a large pivotal trial for Cologuard(TM), its non-
invasive, stool-based DNA colon cancer screening test. Exact confirmed that it
is using an MDxHealth methylation biomarker together with MDxHealth's
methylation specific PCR (MSP) platform in Cologuard.
 
Exact's multi-center DeeP-C study (Multi-Target Colorectal Cancer Screening Test
for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer) will
generate data to support its planned PMA submission to the U.S. Food and Drug
Administration (FDA) in 2012. The company began enrolling patients in the study
on June 30, 2011. It is planning to qualify approximately 60 sites in the United
States and Canada for the study. Those sites are expected to enroll more than
10,000 patients between the ages of 50 and 84 who are at average risk for
colorectal cancer.
 
"We are delighted with Exact Sciences' progress and the start of the company's
important pivotal trial of its advanced screening test for colorectal cancer,"
said Dr. Jan Groen, CEO of MDxHealth. "Based on a market penetration of 30%
Exact is targeting a market opportunity of more than $1 billion in annual sales
in the US alone. Once the test is commercialized, MDxHealth stands to receive
royalties on net sales of Cologuard."
 
About MDxHealth
MDxHealth is a leading molecular diagnostics company that develops and
commercializes oncology-based molecular diagnostic testing and companion
diagnostics for personalized medicine. The company's numerous cancer tests are
based on proprietary gene methylation technology and assist physicians with the
diagnosis of cancer, prognosis of recurrence risk, and prediction of response to
a specific therapy. MDxHealth collaborates with leading cancer research center
such as Johns Hopkins University, Duke University, Lovelace Respiratory Research
Institute, Eastern Virginia Medical School, Cleveland Clinic, Memorial Sloan
Kettering, and major European academic medical centers. The company has a number
of commercial and collaborative partnerships with LabCorp, Merck & Co./Schering
Plough, GlaxoSmithKline Biologicals, Roche, Merck KGaA, Qiagen, Pfizer and other
industry leaders.
More information can be found on the Company website:www.mdxhealth.com or on
twitter at the following address: www.twitter.com/mdxhealth.
 
For more information:
Dr. Jan Groen, CEO                             Hans Herklots
MDxHealth                                        Capricorn One
+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.
 
2011-08-03 EXACT ENG:
http://hugin.info/137314/R/1535548/468287.pdf
 
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.

Source: MdxHealth via Thomson Reuters ONE
 
[HUG#1535548]
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