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IRVINE, California and HERSTAL, Belgium, March 18, 2019 / PRNewswire / – MDxHealth SA (Euronext: MDXH.BR) today announces positive data from a clinical optimization and validation study performed prior to SelectMDx biopsy® were presented to the 34th Annual Conference of the European Urological Association (EAU) in Barcelona, Spain, March 15-19, 2019.
This pan-European multicenter clinical trial was designed to optimize and validate SelectMDx in the evaluation of the risk of high-grade prostate cancer (PCA) in men with high prostate specific antigen (PSA) levels. Data from the study showed that SelectMDx accurately predicts low-risk prostate cancer and aggressive prostate cancer in all patient groups.
"This retrospective clinical validation study clearly confirms the value of the test to guide urologists in the identification of men at risk for aggressive disease, likely to benefit from a biopsy or mpMRi procedure, " m said Dr. Jack Schalken, Professor of Experimental Urology at the Radboud Medical Center in Nijmegen, The Netherlands. "The performance of SelectMDx in this multicentre study confirms previously published data regarding the intended use of the test."
Design and results of the study
The study population consisted of 1 955 men from The Netherlands, la France and Germany prostate cancer suspected and having undergone an initial prostate biopsy between December 2007 and December 2014.
Subjects were divided into training and validation cohorts. Post-DRE urine samples were collected from all subjects prior to biopsy and badessed with SelectMDx. Urinary RNA biomarkers were combined with other risk factors in a clinical model and the model coefficients were optimized for maximum sensitivity and negative predictive value (NPV) for PC GG2 PCa at subjects in the cohort forming with PSA <10 ng / mL. Version 2.0 of the Prostate Cancer Prevention Test (PCPT) risk calculator was used for comparison purposes.
For subjects in the PSA validation cohort <10 ng / mL (N = 715), the AUC SelectMDx was 0.82, the sensitivity was 89%, the specificity was 53%, and the NPV was 95%. while the PCPTRC AUC was 0.70. The performance of SelectMDx for the full validation cohort (all PSA levels, N = 916) was 0.85, with sensitivity and NPV of 93% and 95%, respectively.
"These data provide further evidence of SelectMDx's ability to provide actionable results, which can help urologists make important clinical decisions," m said Mike McGarrity, Managing Director of MDxHealth. "In addition, we believe that the systematic implementation of SelectMDx could enable healthcare systems to realize substantial savings and benefit patients by reducing the number of unnecessary invasive diagnostic procedures and treatments."
In la France, Germany and The Netherlands In total, approximately 400,000 prostate biopsies are performed each year, resulting in approximately 115,000 new cases of prostate cancer diagnosed per year. A recent cost-effectiveness study conducted for SelectMDx in these countries, where SelectMDx is used to stratify men for biopsy based on the likelihood that they harbor the aggressive form of PCa, has shown cost savings per patient and per year. $ 1,402 in la France, $ 505 in Germany and $ 147 in the Netherlands.
On an annual basis, the overall savings achieved by the health systems of these countries were respectively $ 184 million, $ 68 million and $ 3 million. In March 2018SelectMDx has been included in the UAE clinical guidelines, which help clinicians make informed treatment decisions. Since the introduction of SelectMDx in Europe in 2016, more than 19,000 patients were tested with SelectMDx.
About SelectMDx® for Prostate Cancer
Of the nearly 2 million prostate biopsies performed each year, less than one-third identify cancer. Most of these men could have avoided a painful and invasive prostate biopsy procedure, with its complications and costs. SelectMDx for Prostate Cancer is a patented molecular diagnostic test based on urine that offers a noninvasive liquid biopsy method for badessing the risk of prostate cancer in a patient. SelectMDx helps identify men with an increased risk of aggressive, potentially life-threatening prostate cancer that could benefit the most from a prostate biopsy and earlier detection. The test provides a negative predictive value (NPV) of 98% for clinically significant diseases, which reduces the use of MRI procedures and invasive prostate biopsies by up to 50%, thereby reducing health care costs. The test was included in the clinical guidelines of the European Urological Association (UAE) 2018.
About MDxHealth®
MDxHealth is a multinational health organization that provides usable molecular diagnostic information to personalize the diagnosis and treatment of cancer. The company's tests are based on genetic technologies, epigenetics (methylation) and other proprietary molecular technologies. They help doctors diagnose urologic cancers, predict the risk of recurrence, and predict the response to a specific treatment. The European headquarters of the company is in Herstal, Belgium, with laboratory operations in Nijmegen, The Netherlandsand the US headquarters and laboratory activities based at Irvine, California. For more information, visit mdxhealth.com and follow us on social media at the address: twitter.com/mdxhealth, facebook.com/mdxhealth and linkedin.com/company/mdxhealth.
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This press release contains forward-looking statements and estimates regarding the expected future performance of MDxHealth and the market in which it operates. These statements and estimates are based on known and unknown badumptions and risk estimates, uncertainties and other factors that have been found to be reasonable but may not prove to be accurate. Actual events are difficult to predict, may depend on factors beyond the control of the company and may be very different. MDxHealth expressly disclaims any obligation to update any forward-looking statements contained in this news release to reflect any change in its expectations in this regard or any change in the events, conditions or circumstances upon which such statement is based, unless required by law or regulation. This press release does not constitute an offer or invitation to sell or buy securities or badets of MDxHealth in any jurisdiction. No securities of MDxHealth may be offered or sold in United States without registration under the United States Securities Act of 1933, as amended, or in accordance with any exemption, and in accordance with any applicable US 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.
SOURCE MDxHealth
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