MDxHealth establishes US CLIA laboratory in Irvine, CA, and makes key hires to expand US team

Donnerstag, 18.08.2011 08:00 von Hugin - Aufrufe: 248

DURHAM, NC, and LIEGE, BELGIUM - August 18, 2011 - MDxHealth SA (NYSE Euronext:
MDXH), a leading molecular diagnostics company in the field of personalized
medicine, announced today that it has signed a lease agreement for a state-of-
the-art laboratory and office facilities in Irvine, CA and has filed for CLIA
certification of the US site. In addition, MDxHealth has filed for CLIA
certification of its Liege facility.
 
The two-pronged commercialization strategy of the company is built on the
development of companion diagnostics with top tier pharmaceutical companies, and
on developing its own proprietary diagnostic, prognostic and predictive assays
for a number of cancer indications to be commercialized through its CLIA
laboratories. MDxHealth expects to launch its first assay for prostate cancer in
2012.
 
In conjunction with identifying a prime 13,448 square foot location in Irvine,
MDxHealth has hired Miriam Reyes, as Senior Director Laboratory Operations, and
Beth Davis as Senior Director Managed Care. Both bring extensive experience in
molecular cancer diagnostics to MDxHealth. MDxHealth is building a world class
scientific and commercial team for its US operations and plans further expansion
in the months ahead. In September 2010, the company already announced the
appointments of Dr. Melissa A. Thompson as Vice President Regulatory Affairs and
Quality Assurance, and of Christopher Thibodeau as Vice President Commercial
Operations.
 
"Establishing a US infrastructure that includes CLIA certification will allow us
to penetrate the US market more efficiently and is key to our long-term business
strategy," said Dr. Jan Groen, CEO of MDxHealth. "Irvine is a hotbed for the
healthcare industry and an excellent location for our company to attract the
best and brightest talent, and our site is large enough to accommodate our
growth over the next few years. I am also very pleased that we were able to
attract two highly experienced industry professionals to manage laboratory
operations and reimbursement."
 
About CLIA
In the US, the Centers for Medicare & Medicaid Services (CMS) regulates
laboratory testing through the Clinical Laboratory Improvement Amendments
(CLIA). The objective of the CLIA program is to ensure quality laboratory
testing. A CLIA lab is a laboratory that operates under CLIA supervision. In
total, CLIA covers approximately 200,000 laboratory entities. Unlike in Europe,
in the US almost 70% of laboratory testing is outsourced to commercial CLIA
labs. This constitutes a highly attractive commercial market, as one CLIA lab
can service the entire US.
 
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 centers
such as Johns Hopkins University, Harvard Medical School, Beth Israel Deaconess
Medical Center, Cleveland Clinic, Duke University, University of California Los
Angeles, Lovelace Respiratory Research Institute, University of Colorado Medical
Center, 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.
 
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
 
2011-08-18 ENG:
http://hugin.info/137314/R/1538849/470298.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#1538849]
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