MDxHealth Receives ISO 9001:2008 Certification for its Commercial U.S. Based CLIA Laboratory
(Thomson Reuters ONE) -
IRVINE, CA, and LIEGE, BELGIUM - 8:00 AM, April 2, 2013 - MDxHealth SA (NYSE
Euronext: MDXH), a leading molecular diagnostic company that develops and
commercializes epigenetic tests to support cancer treatment, today announced
that its Irvine, CA based CLIA certified and College of American Pathologists
(CAP) accredited laboratory has received a certification of conformity to ISO
9001:2008 from DEKRA Certification, Inc., Chalfont, PA.
ISO's internationally recognized standard confirms that MDxHealth Quality
Management System consistently meets customer and regulatory requirements for
research, product design, assay development and clinical molecular diagnostic
services and pharmaco clinical trials testing.
"The ISO 9001:2008 certification for our quality management system, in
combination with our CLIA certification and CAP accreditation, demonstrates
MDxHealth's commitment to uphold the highest quality standards in assay
development and clinical diagnostic testing," said Dr. Jan Groen, CEO of
MDxHealth. "As companion diagnostic assays play an increasingly important role
in the development and validation of new cancer therapies, pharmaceutical
companies recognize the importance of quality control even at the earliest
stages of Research and Development. The ISO certification of our Irvine
facility further strengthens our position as a global partner for PharmacoMDx
test development"
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, ConfirmMDx(TM) for Prostate
Cancer, has been shown to help distinguish patients who have a true-negative
biopsy from those who may have undetected 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 prostate, brain and
lung cancers. The company is based in Irvine, California with a European
headquarters in Liege, Belgium. For more information visit MDxHealth's website
at www.mdxhealth.com.
For more information:
Dr Jan Groen Mike Sinclair Seth Lewis
President and CEO
MDxHealth Halsin Partners The Trout Group
US: +1 949 812 6979 UK: +44 20 7318 2955 US: +1 646 378 2952
BE: +32 4 364 20 70 Cell: +44 7968 022075
info(at)mdxhealth.com msinclair(at)halsin.com slewis(at)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.
Clik here for the full release:
http://hugin.info/137314/R/1689209/554361.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 (TM) via Thomson Reuters ONE
[HUG#1689209]
Unternehmensinformation / Kurzprofil:
Datum: 02.04.2013 - 08:02 Uhr
Sprache: Deutsch
News-ID 244852
Anzahl Zeichen: 5312
contact information:
Town:
Liège
Kategorie:
Business News
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