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MDxHealth : SelectMDx® Liquid Biopsy Test for Prostate Cancer Included in the 2019 Italian Society of Urology Guidelines

March 5, 2019

NEWS RELEASE

MDxHealth’s SelectMDx® Liquid Biopsy Test for Prostate Cancer Included in the 2019 Italian Society of Urology Guidelines

A significant milestone to increase adoption of SelectMDx in Italy

IRVINE, CA, and HERSTAL, BELGIUM - 07:00 CET, March 5, 2019 - MDxHealth SA (Euronext: MDXH.BR) today announces that SelectMDx® liquid biopsy test for prostate cancer has been included in the 2019 Italian Society of Urology (SIU) guidelines.

The SIU guidelines assist clinicians in making informed treatment decisions, taking into account the available scientific data. The inclusion of SelectMDx® in the SIU guidelines will enable adoption of the test in Italy and contribute to the ongoing reimbursement process in that country.

In Italy, c.100,000 prostate biopsies are performed annually, resulting in c.42,000 newly diagnosed prostate cancer patients per year. A recent cost-effectiveness study in Italian men with elevated prostate specific antigen (PSA) compared the use of SelectMDx® to stratify men for biopsy based on the likelihood of them harboring the aggressive form of prostate cancer with the current standard of care consisting of an initial prostate biopsy.

In the study, SelectMDx® demonstrated a cost saving of €762 per patient per year. On an annual basis the overall savings for Italy’s healthcare system would be approximately €105million. These findings were published in the journal Prostate Cancer and Prostatic Diseases. SelectMDx® is available in the US and all EU member states and nearly 19,000 men were tested in 2018, an increase of over 60% compared to 2017.

Dr. Angelo Porreca, MD, President of the Italian Association of Urologists in Private Hospitals (UrOP), Member of SIU, commented: “The addition of SelectMDx for prostate cancer in the 2019 Guidelines from the Italian Society of Urology demonstrates the value of the test in helping urologists make the right clinical decisions for patients, thus reducing unnecessary biopsies and/or stratifying patients that should undergo further examinations such as mpMRI ”

Prof. Dr. Ir. Wim Van Criekinge, Chief Scientific Officer of MDxHealth, commented: “The inclusion in the SIU 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 can then forego a painful and unnecessary biopsy, preventing overdiagnosis and overtreatment.”

About SelectMDx® for Prostate Cancer Of the nearly 2 million prostate biopsies performed each year, less than a third identify cancer. Most of these men could have avoided a painful and invasive prostate biopsy procedure, with its associated complications and costs. SelectMDx® for Prostate Cancer is a proprietary urine-based, molecular diagnostic test that offers a non-invasive liquid biopsy method to assess a patient’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 delivers a negative predictive value (NPV) of 98% for clinically significant disease, helping to reduce the need for MRI procedures and invasive prostate biopsies by up to 50%, thereby reducing healthcare costs. The test has been included in the 2018 European Association of Urology (EAU) clinical guidelines.

About MDxHealth 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 social media at: twitter.com/mdxhealth, facebook.com/mdxhealth and linkedin.com/company/mdxhealth.

For more information:

MDxHealth Mike McGarrity Consilium Strategic Communications David Daley, Chris Welsh, Jonathan Birt US: +1 949 812 6979 UK: +44 20 3709 5701 BE: +32 4 257 70 21 mdxhealth@consilium-comms.com info@mdxhealth.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, 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.

Attachment

-- MDxHealth Italy guideline.pdf