MDxHealth to Participate in Prospective Clinical Validation Study with AssureMDx for Bladder Cancer

IRVINE, Calif. and HERSTAL, Belgium, Nov. 9, 2015 (GLOBE NEWSWIRE) -- MDxHealth SA (Euronext: MDXH), announced today that it has entered into an agreement with Erasmus University Medical Center Rotterdam (Erasmus MC) for the inclusion of MDxHealth's AssureMDx for Bladder Cancer, a urine-based, liquid biopsy test, into a prospective clinical study designed to assess the ability of urine-based molecular tests to stratify patients with non-muscle invasive bladder cancer (NMIBC) for recurrence monitoring.

A total of 2,000 urine samples from 435 patients will be collected in a, multi-center, two-arm, prospective randomized clinical trial financed by ZonMw, the Netherlands Organisation for Health Research and Development and Erasmus MC. The study is designed to assess the test's ability to safely reduce the number of invasive cystoscopies performed during follow-up of patients with NMIBC with a low/intermediate risk of recurrence or progression. The study will also examine whether the addition of urine tests to follow-up of patients with higher risk of recurrence and progression leads to earlier detection of potentially dangerous recurrences. All urine samples will be tested using AssureMDx assay.

Prof. Dr. Ellen Zwarthoff, principal investigator at Erasmus MC commented, "Given that current diagnostic tools are invasive and at times costly, the potential for urine-based molecular tests to help reduce the number of invasive cystoscopies for low or intermediate risk patients, while providing earlier detection of possible recurrence for those at high-risk, would be a major advance for patient care. As such, we look forward to collaborating with MDxHealth on this important clinical trial."

About Bladder Cancer

In the US and EU, over 170,000 patients are diagnosed with bladder cancer every year, and over 50,000 patients will die from the disease. Annually in the US alone, it is estimated that over 1 million patients with hematuria (blood in urine) are referred to urologists for fear of bladder cancer. The traditional tools and procedures employed for the detection of bladder cancer have some limitations, not the least of which are cost and invasiveness, but also these methodologies are prone to miss some small bladder tumors, satellite lesions as well as carcinoma in situ. Importantly, bladder cancer is one of the most expensive cancers to treat given more than half of all early stage bladder cancer patients will recur in the three years following treatment.

About Erasmus University Medical Center

Erasmus MC is the largest and most authoritative University Medical Center in the Netherlands. Almost 13,000 staff members work within the core tasks of patient care, education, and scientific research on the continuous improvement and enhancement of individual patient care and social healthcare. They develop high-level knowledge, pass this on to future professionals, and apply it in everyday patient care.

About MDxHealth

MDxHealth is a multinational healthcare company that provides actionable epigenetic 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 may contain 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.

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Source: MdxHealth (TM)