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

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 .  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."

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.

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 and follow us on social media at: , and .

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