MDxHealth (R): Develops Blood Test to Guide Precision-Treatment of Castration-Resistant Prostate Cancer Patients

NEWS RELEASE/REGULATED INFORMATION/INSIDE INFORMATION

  • Study demonstrates test can add prognostic information on overall survival
  • Earlier assessment of treatment response can help identify resistance sooner
  • Over 233,000 CRPC patients under treatment globally each year

HERSTAL, BELGIUM and IRVINE, CA, January 18, 2018 - MDxHealth SA ("MDxHealth, or the "Company"), (Euronext: Brussels MDXH.BR), an international healthcare company, developing and offering molecular diagnostic tests to personalize the diagnosis and treatment of urologic cancer, today announced promising research results with a new liquid biopsy test in development. Data from this study, published in The Prostate, January 12, 2018 indicate that the test has the potential to help guide personalized treatment of castration-resistant prostate cancer (CRPC) patients.

Most patients with advanced prostate cancer (PCa) will eventually develop CRPC, which accounted for over 26,000 deaths in the US during 2016 alone. Treatment options for CRPC have improved, with a combination of chemotherapy, androgen receptor (AR)-targeted therapeutics, and radiopharmaceuticals now available, however mortality remains high. Importantly, monitoring the patient's response to treatment is usually evaluated 3-4 months after treatment is initiated, and remains largely dependent on PSA measurements, bone scintigraphy and other imaging modalities. This delay in measuring therapeutic response could limit the opportunity to adjust the treatment regimen at an early stage, when there is the best chance for cure. There are currently no biomarkers available to assess treatment response at an earlier stage.

MDxHealth's PCR-based, non-invasive blood test was developed to measure the hypermethylation levels of two biomarkers (GSTP1 and APC) in plasma cell-free DNA. The results of the forementioned prospective study, with 47 CRPC patients and 30 controls, indicate that the baseline value of the biomarkers, prior to treatment, is prognostic for overall survival. In addition, the subsequent variations of biomarker levels during treatment could help identify non-responders, which may enable improved personalized treatment of CRPC patients in the future.

Prof. Dr. Jack Schalken, principle investigator and Research Director, of Radboud University Medical Center, Department of Urology, Nijmegen, The Netherlands, said: "One of the major unmet needs in the treatment of patients with castrate resistant prostate cancer is to assess prognosis and response to systemic therapy. A quantitative test that can provide real-time insights into a patient's therapeutic response, which may allow for early intervention with an alternative treatment regimen, could ultimately improve survival."

Dr. Jan Groen, CEO of MDxHealth, commented:

"Given the severe mortality rate associated with CRPC, understanding a patient's prognosis and early response to the prescribed treatment regimen, is crititically important. With an estimated 233,000 CRPC patients undergoing treatment each year, the clinical need for a precision diagnostic test is quite significant. Our test gives us the opportunity to engage with pharmaceutical companies to support their drug development programs and to monitor patients enrolled in their clinical trials." 

About MDxHealth

MDxHealth is a multinational healthcare company, listed at the Brussels, Belgium stock exchange (Euronext: 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. 

ConfirmMDx for Prostate Cancer helps urologists identify low-risk men who may forego an unnecessary repeat biopsy and high-risk men who may benefit from intervention. ConfirmMDx is the first epigenetic, and only tissue-based test in the 2016 NCCN Guidelines for early detection of prostate cancer and that addresses false negative biopsy concerns. ConfirmMDx has qualified for Medicare reimbursement and covered by numerous private health insurance plans.

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

MDxHealth

US: +1 949 812 6979

BE: +32 4 364 20 70

info@mdxhealth.com

LifeSpring LifeSciences Communication, Amsterdam, The Netherlands

Leon Melens

+31 6 538 16 427

lmelens@lifespring.nl

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.