Key step for MDxHealth’s in vitro diagnostic (IVD) strategy in Europe
Certification enables development, manufacturing and distribution of IVD products
IRVINE, CA, and HERSTAL, BELGIUM, December 16, 2016 – MDxHealth SA (Euronext: MDXH), announces that its laboratory in Nijmegen, The Netherlands has received ISO 13485:2016 certification for the design, development, manufacture and distribution of in vitro molecular diagnostic products, as well as client services and service testing for molecular diagnostic detection of oncological diseases.
ISO 13485:2016 is the established quality standard for manufacturers of finished medical devices and/or critical components within a medical device platform. The standard specifies requirements for a quality management system to demonstrate a company’s ability to consistently provide products that meet applicable statutory and regulatory requirements.
“ISO certification of our Dutch operation is an important milestone and a key step for our in vitro diagnostics strategy for Europe and other international markets,” reported Dr. Jan Groen, Chief Executive Officer of MDxHealth. “Under this certification we can develop, manufacture and distribute in vitro diagnostic (IVD) products, and now we can begin global marketing and distribution of our SelectMDx IVD kit over the course of the coming year.”
MDxHealth is a multinational healthcare company that provides actionable molecular diagnostic information to personalize the diagnosis and treatment of cancer. The company’s tests are based on proprietary genetic, epigenetic (methylation) and other molecular technologies and assist physicians with the diagnosis of urologic cancers, prognosis of recurrence risk, and prediction of response to a specific therapy. The Company’s European headquarters are in Herstal, Belgium, with laboratory operations in Nijmegen, The Netherlands, and US headquarters and laboratory operations based in Irvine, California. For more information, visit mdxhealth.com and follow us on Twitter at: twitter.com/mdxhealth.
| For more information:
Dr. Jan Groen, CEO
US: +1 949 812 6979
BE: +32 4 364 20 70
Jonathan Birt, Chris Welsh, Hendrik Thys (PR & IR)
Consilium Strategic Communications
UK: +44 20 3709 5701
US: +1 917 322 2571 (Rx Communications Group LLC)
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, SelectMDx, AssureMDx and PredictMDx are trademarks or registered trademarks of MDxHealth SA. All other trademarks and service marks are the property of their respective owners.