NEWS RELEASE / REGULATED INFORMATION / INSIDE INFORMATION
A significant milestone in MDxHealth’s strategy to increase adoption of SelectMDx®
HERSTAL, BELGIUM and IRVINE, CA – 07:00 CEST, March 19, 2018 – MDxHealth SA (Euronext Brussels: MDXH.BR), a world leader in molecular diagnostics for urological cancers, announces today that SelectMDx®, the Company’s non-invasive ‘liquid biopsy’ test that helps to identify patients at increased risk of having aggressive prostate cancer, has been included in the 2018 European Association of Urology (EAU) guidelines.
The EAU guidelines assist clinicians in making informed treatment decisions, taking into account the available scientific data. The inclusion of SelectMDx in the EAU guidelines will enable adoption of the test in EU member states specific guidelines and contribute to drive payor adoption.
Dr. Jan Groen, Chief Executive Officer of MDxHealth, commented: “This is an important milestone for MDxHealth, in line with our strategy to increase the adoption of SelectMDx in Europe and the US. The inclusion in the EAU guidelines is an important recognition of the clinical value of SelectMDx as a non-invasive method of identifying men at high risk of having the aggressive and potentially lethal form of prostate cancer and men at low risk who may forego a painful biopsy, preventing over diagnosis and over treatment.”
SelectMDx is available in the US and all EU member states. Since the introduction of the SelectMDx test mid 2016, over 15,000 patients have been tested and 15 commercial contracts were signed with US based insurance companies.
SelectMDx is based on mRNA biomarkers isolation from urine. The presence of two proprietary biomarkers, HOXC6 and DLX1 mRNA levels, is assessed to provide an estimate for the risk of both the presence of prostate cancer on biopsy as well as the presence of high-risk prostate cancer. In the Clinical Diagnosis paragraph of the new guidelines, The EAU Prostate Cancer (PCa) Guidelines Panel stated that “based on the available evidence, some biomarkers could help in discriminating between aggressive and non-aggressive tumours, with an additional value compared to the prognostic parameters currently used by clinicians.”[i]
MDxHealth is a multinational healthcare company, listed at the Brussels, Belgium, stock exchange (Euronext Brussels: MDXH.BR), 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.
SelectMDx for Prostate Cancer is a proprietary urine-based, molecular diagnostic test that offers a non-invasive ‘liquid biopsy’ method to assess a man’s risk for prostate cancer. SelectMDx helps identify men at increased risk of harboring aggressive, potentially lethal, prostate cancer who may benefit most from a prostate biopsy and earlier detection. The test helps to reduce the need for MRI procedures and invasive prostate biopsies by up to 50%, thereby reducing healthcare costs.
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 social media at: twitter.com/mdxhealth, facebook.com/mdxhealth and linkedin.com/company/mdxhealth.
For more information:
Dr. Jan Groen, CEO
US: +1 949 812 6979
BE: +32 4 364 20 70
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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, PredictMDx and UrNCollect are trademarks or registered trademarks of MDxHealth SA. All other trademarks and service marks are the property of their respective owners.