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MDxHealth Announces Presentation of Positive Data for SelectMDx and ConfirmMDx in Prostate Cancer Diagnosis
Date:2/16/2019

MDxHealth SA (Euronext: MDXH.BR) today announced that positive data and observations from multiple studies and patient registries demonstrating the value of SelectMDx and ConfirmMDx for Prostate Cancer diagnosis, will be presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), taking place in San Francisco, California from February 14-16, 2019.

Data highlights:

  • $500 million in annual savings when SelectMDx is used prior to multi-parametric magnetic resonance imaging (mpMRI) for the identification of patients at high risk of aggressive prostate cancer.
  • SelectMDx outperforms the Prostate Health Index (phi) for the detection of high-grade prostate cancer.
  • Retrospective validation of SelectMDx confirms robust clinical performance.
  • Clinical utility study demonstrates that ConfirmMDx had a significant positive impact on repeat prostate biopsy decision-making.

"These results clearly demonstrate the superiority of our diagnostic tests and confirm our commitment to improving the lives of patients at high risk of aggressive prostate cancer by offering a valuable alternative for early diagnosis of prostate cancer,” stated Dr. Jan Groen, CEO of MDxHealth.

Further details of the studies can be found below. All abstracts were presented at the Poster Session entitled “Prostate Cancer and Trials in Progress” on Thursday, February 14 from 11:30 AM-1:00 PM PST and 5:30-6:30 PM PST.

Validation of a 2-Gene mRNA Urine Test for Detection of High-Grade Prostate Cancer in German Men
Summary: In this first validation study of SelectMDx in German men, investigators evaluated the test in men who underwent an initial biopsy to determine SelectMDx’s effectiveness in detecting high-grade, or aggressive, prostate cancer (PCa). The study showed that a SelectMDx result was 95% accurate for ruling out the presence of high-grade PCa and that 46% of potentially unnecessary biopsies could have been avoided if the initial biopsy had been performed based on SelectMDx results alone.
Moderated poster: Board E20. For full abstract and list of authors, click here.

Cost-Effectiveness of a 2-Gene Urine Biomarker Assay in MRI Strategies for the Initial Detection of Prostate Cancer
Summary: Using a decision-analytic computer model, investigators assessed the cost-effectiveness of SelectMDx by analyzing the test’s use in a population of U.S. men at-risk for prostate cancer prior to and after receiving an MRI. The study found that using SelectMDx prior to an MRI improved health outcomes and saved $1,590 per patient, or approximately $496 million for the yearly population of men at risk in the US. This study shows that the use of SelectMDx to guide prostate biopsy decision-making can significantly improve health outcomes and lower costs.
Moderated poster: Board E15. For full abstract and list of authors, click here.

SelectMDx vs. Prostate Health Index in the Identification of High-Grade Prostate Cancer
Summary: Investigators evaluated the clinical utility of SelectMDx and Prostate Health Index (phi) tests for diagnosis of high-grade PCa as compared with transperineal mapping biopsy (TMB) results. Using multivariate logistic regression analyses, researchers found that SelectMDx was significantly better than phi for diagnosing high-grade PCa. With high sensitivity and negative predictive value, SelectMDx test is more useful than phi for screening patients at risk of high-grade PCa prior to biopsy.     
Moderated poster: Board B18. For full abstract and list of authors, click here.

Clinical Utility Study of ConfirmMDx for Prostate Cancer in a Community Urology Practice
Summary: In this utility study, investigators provided ConfirmMDx results to community urology physicians for use in repeat biopsy decision-making. The study found that ConfirmMDx had a significant impact on repeat prostate biopsy decision-making. Repeat biopsy rates in ConfirmMDx positive men were six-fold higher than in ConfirmMDx negatives — 32.3% for ConfirmMDx positive men as compared to 5.8% for ConfirmMDx negative men. These results reflect the clinical utility of ConfirmMDx for biopsy decision-making in real world clinical practice.
Moderated poster: Board E18. For full abstract and list of authors, click here.

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 http://www.mdxhealth.com and follow us on social media at: http://www.twitter.com/mdxhealth, http://www.facebook.com/mdxhealth and http://www.linkedin.com/company/mdxhealth.

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