SelectMDx Chosen by Michigan Medicine as Pre-biopsy Diagnostic Tool in Groundbreaking US Prostate Cancer Risk Clinic

NEWS RELEASE / REGULATED INFORMATION / INSIDE INFORMATION

IRVINE, CA, and HERSTAL, BELGIUM - March 8, 2017 - MDxHealth SA (Euronext: MDXH.BR) today announced that SelectMDx(TM) for Prostate Cancer, a non-invasive urine-based test that guides patient selection for prostate biopsy, will be used for the newly launched prostate cancer risk clinic at the University of Michigan.

The Michigan Medicine prostate cancer risk clinic will monitor men who have been previously diagnosed with genetic mutations, particularly BRCA1 and BRCA2, that indicate a genetic predisposition to aggressive prostate cancer. These high-risk patients will be tested with SelectMDx for Prostate Cancer to ascertain the likelihood that clinically significant prostate cancer (Gleason Score greater than or equal to 7) would be detected upon prostate biopsy, helping with patient management decisions.

"Prostate cancer is the second leading cause of cancer deaths among men in the United States," said Todd Morgan, M.D., Assistant Professor of Urology at the University of Michigan, Ann Arbor and the urological surgeon leading the risk clinic at Michigan Medicine. "Now, more than ever, we have an understanding of which men have cancer that needs to be treated and which men have cancer that can be closely watched. These men who have inherited mutations are much more likely to have aggressive prostate cancer. We know that treatment of aggressive prostate cancer works-it prevents death and suffering and that's what this initiative is really about."

Although there remains some controversy about which men should undergo routine screening for prostate cancer, based on concerns about the accuracy of the prostate specific antigen (PSA) test, recent studies have indicated that men who have BRCA1 and BRCA2 mutations are at high risk for aggressive prostate cancer and would benefit from closer monitoring.1,2  The SelectMDx test can improve upon the traditional clinical data to identify men, in this high-risk BRCA-mutation pool, who may harbour prostate cancer. By targeting biomarkers associated with aggressive prostate cancer, SelectMDx can help distinguish the men with a high likelihood of prostate cancer upon biopsy, and the probability for high-grade disease, from the men at very low risk for aggressive disease with a 98% negative predictive value (NPV).  

"The Michigan Medicine prostate cancer risk clinic is the first of its kind and we hope to see a global expansion of such clinics for genetically high-risk men. Early diagnosis remains critical for men harboring aggressive disease, when there is an opportunity for curative treatment," said Dr. Jan Groen, CEO of MDxHealth. "Michigan Medicine's choice of SelectMDx for its prostate cancer risk clinic speaks volumes about the clinical value our test brings to the diagnostic process."

About Michigan Medicine
Michigan Medicine seeks to create the future of healthcare through the discovery of new knowledge for the benefit of patients and society; educate the next generation of physicians, health professionals and scientists; and serve the health needs of its citizens. Michigan Medicine pursues excellence every day in its three hospitals, 40 outpatient locations and home care operations that handle more than 2.1 million outpatient visits a year. The University of Michigan Medical School is one of the nation's biomedical research powerhouses, with total research funding of more than $470 million. For more information: www.michiganmedicine.org

About SelectMDx for Prostate Cancer
Over 2 million prostate biopsies are performed each year with less than a third finding cancer. Most of these men could have avoided a painful and invasive prostate biopsy procedure, with its associated side effects and costs. SelectMDx for Prostate Cancer is a proprietary urine-based, molecular diagnostic test that offers a non-invasive "liquid biopsy" method to identify patients at low risk for prostate cancer, helping to both reduce unnecessary prostate biopsy procedures with their concomitant complications and expense and to identify those men at increased risk of harbouring high-grade disease who may benefit most from earlier detection. 

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
info@mdxhealth.com

References:

  1. Bancroft E, et al. (2014) Targeted Prostate Cancer Screening in BRCA1 and BRCA2 Mutation Carriers: Results from the Initial Screening Round of the IMPACT Study. Eur Urol 66: 489-499.
  2. Pritchard C, et al. (2016) Inherited DNA-Repair Gene Mutations in Men with Metastatic Prostate Cancer. N Engl J Med 375:443-453.

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.