NEWS RELEASE / REGULATED INFORMATION / INSIDE INFORMATION

ABSTRACT #MP33-17                                                                                       

IRVINE, CA, and HERSTAL, BELGIUM – 15:30 CEST, May 13, 2017 – MDxHealth SA (Euronext: MDXH.BR) today announced results from a retrospective study that showed SelectMDx(TM) for Prostate Cancer, a liquid biopsy test, identified men at risk for clinically significant prostate cancer who would benefit from a multiparametric MRI (mpMRI) scan. The study findings were presented at the 2017 American Urological Association (AUA) Annual Meeting in Boston, Massachusetts in the US.

This study showed promising results regarding the positive correlation between the SelectMDx risk score and MRI outcomes. An increased SelectMDx risk score was seen in patients who had a suspicious lesion on their MRI scan (p<0.001) thereby establishing the potential of the test to select patients at risk for significant prostate cancer for MRI.

“SelectMDx may aid in the reduction of unnecessary invasive biopsies and the expense associated with mpMRI,” said Prof. Dr. Jack Schalken, study investigator and Research Director, Radboud University Medical Center, Department of Urology, Nijmegen, The Netherlands. “This study showed that SelectMDx can guide appropriate patient selection for mpMRI scans and identify patients who would benefit most from prostate biopsies.”

MRI scans are particularly expensive in the US. Insurance companies and their patients can expect to pay up to $3,000 depending on the medical facility.

About SelectMDx for Prostate Cancer

Of the more than 2 million prostate biopsies performed each year in the US and Europe, less than a third find 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 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 delivers a negative predictive value (NPV) of 98% for clinically significant disease, helping to reduce unnecessary MRI procedures and invasive prostate biopsies by approximately 50%, thereby reducing healthcare costs.

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 Twitter at: twitter.com/mdxhealth.

For more information:

Shalon Roth, EVP Corporate Communications
MDxHealth
UK: +44 (0)7393 906278
@ShalonRoth
info@mdxhealth.com

References:

1. Hendriks RJ, et al. (2017) Potential role of a novel urinary biomarker-based risk score to select patients for multiparametric MRI for prostate cancer detection. American Urological Association (EAU) Annual Meeting. Abstract # MP33-17. 13 May 2017.

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.