MDxHealth Receives ISO 9001:2008 Certification for Its Commercial U.S. Based CLIA Laboratory
(firmenpresse) - IRVINE, CA and LIEGE, BELGIUM -- (Marketwired) -- 04/02/13 -- MDxHealth SA (EURONEXT BRUSSELS: 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"
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 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 .
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.
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Dr Jan Groen
President and CEO
MDxHealth
US: +1 949 812 6979
BE: +32 4 364 20 70
Mike Sinclair
Halsin Partners
UK: +44 20 7318 2955
Cell: +44 7968 022075
Seth Lewis
The Trout Group
US: +1 646 378 2952
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Datum: 02.04.2013 - 06:39 Uhr
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News-ID 244802
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