Non-invasive, urine-based prostate cancer test available in the Netherlands from November 2015
IRVINE, CA, and HERSTAL, BELGIUM - October 13, 2015 - MDxHealth SA (Euronext: MDXH.BR), announced today, the commercial launch of the Company's new non-invasive, urine-based test, SelectMDx(TM) for Prostate Cancer, in Europe via the Company's state-of the-art laboratory facilities in Nijmegen, the Netherlands.
MDxHealth is offering SelectMDx patient testing initially in the Netherlands, with plans to expand the offering to other European countries in early 2016. In conjunction with the commercial launch of the test, MDxHealth and DDL Diagnostic Laboratory in Rijswijk, the Netherlands, have reached an agreement for the manufacture of CE-marked SelectMDx test kits.
DDL Diagnostic Laboratory, which is also the largest service provider of the existing prostate cancer PCA3 test in the Netherlands, has recently announced its decision to discontinue processing of the PCA3 assay. As a result, MDxHealth anticipates that it will be the principal provider of urine-based prostate cancer testing for patients with elevated PSA levels (3.0 - 10.0 ng/ml) in the Netherlands.
The novel biomarkers that make up SelectMDx were discovered by Prof. Dr. Jack Schalken, original developer of the PCA3 assay, and his team at the Department of Urology at Radboud University Medical Center in the Netherlands. The SelectMDx test was designed to address an unmet need in the stratification of patients at risk for potentially lethal high-grade prostate cancer compared to those with low-grade cancer. In clinical studies, SelectMDx has been shown to outperform PCA3, improving the information available to urologists seeking to further reduce unnecessary invasive biopsy procedures.
"This is an exciting phase for MDxHealth. Our recently acquired laboratory in the Netherlands has given us a platform from which to expand our European operations and launch our first major product offering outside of the US," commented Dr. Jan Groen, CEO of MDxHealth. "Looking to the future, we are in a position to expand the distribution of our CE-marked SelectMDx kit, as well as other uro-oncology tests, across Europe and globally."
About SelectMDxTM for Prostate Cancer
Of the nearly 2 million prostate biopsies performed each year, less than a third find cancer. Most of these men could have avoided a painful and invasive prostate biopsy procedure, with its associated side effects and costs. SelectMDx for Prostate Cancer is a proprietary urine-based, molecular diagnostic test that offers a non-invasive "liquid biopsy" method to identify patients at low risk for prostate cancer, helping to both reduce unnecessary prostate biopsy procedures with their concomitant complications and expense and to identify those men at increased risk of harbouring high-grade disease who may benefit most from earlier detection.
About MDxHealth
MDxHealth is a multinational healthcare company that provides actionable epigenetic and molecular information to personalize the diagnosis and treatment of cancer. The company's tests are based on proprietary gene methylation (epigenetic) technology and assist physicians with the diagnosis of cancer, prognosis of recurrence risk, and prediction of response to a specific therapy. For more information visit mdxhealth.com and follow us on Twitter at: twitter.com/mdxhealth.
| For more information: Dr. Jan Groen, CEO MDxHealth US: +1 949 812 6979 BE: +32 4 364 20 70 info@mdxhealth.com | | Amber Fennell, Chris Welsh, Hendrik Thys (PR & IR) Consilium Strategic Communications UK: +44 20 3709 5701 Cell: + 44 7739658783 mdxhealth@consilium-comms.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, SelectMDx and PredictMDx are trademarks or registered trademarks of MDxHealth SA. All other trademarks and service marks are the property of their respective owners.
