IRVINE, Calif. and HERSTAL, Belgium, April 25, 2016 (GLOBE NEWSWIRE) -- MDxHealth SA (Euronext: MDXH.BR), today announced that data validating the clinical performance of the SelectMDx(TM) for Prostate Cancer test have been published in European Urology.
The study, conducted across six institutions in The Netherlands, was designed to identify methods to improve the detection of clinically significant or aggressive prostate cancer at an early, more treatable stage. Researchers believe that both over-diagnosis and overtreatment of indolent, non-lethal prostate cancer could be reduced if specific biomarkers, which accurately identify men with aggressive tumors, could be used to guide the decision to conduct a biopsy.
Urine samples from two prospective, multicenter studies (n=905) were collected after digital rectal examination (DRE) to measure the mRNA expression levels of the SelectMDx genes, which were previously identified for their ability to specifically detect aggressive prostate cancer. These results were combined with standard clinical risk factors, i.e. DRE, PSA, PSA density, age and family and biopsy history to further improve patient stratification. An algorithm was developed in a training cohort, and successfully validated in an independent cohort. The SelectMDx risk score resulted in an improved identification of men at risk for harboring aggressive prostate cancer, significantly outperforming PSA and PCA3, with an area under the curve (AUC) of 0.90, and a negative predictive value (NPV) of 98% for clinically significant prostate cancer. In addition, SelectMDx resulted in the highest reduction of unnecessary biopsies in men with no or indolent prostate cancer.
"The SelectMDx test will help urologists identify men at very low risk for aggressive disease, who may avoid an unnecessary invasive biopsy procedure," reported Dr. Jack Schalken, Professor of Experimental Urology at the Radboud Medical Center in Nijmegen, The Netherlands. "The test also helps to improve patient selection for biopsy by indicating a patient's individual risk for aggressive, potentially lethal cancer."
"We have witnessed a paradigm shift in the management of prostate cancer over the past decade, with a focus on early detection and treatment of men with aggressive disease," continued Dr. Schalken. "However most experts agree that we need to minimize the diagnosis and overtreatment of men with indolent, non-lethal disease. Why saddle a man with the anxiety associated with a diagnosis of cancer if you do not intend to treat him?"
"Publication of this pivotal multicenter validation study in European Urology, the highest ranked medical journal in the field of urology, illustrates the significance of these data," stated Dr. Jan Groen, CEO of MDxHealth. "In a head-to-head prospective comparison, the SelectMDx test out-performed PSA as well as PCA3, another commonly used biomarker, and sets a new performance standard for non-invasive 'liquid biopsy' tests for use in the detection of clinically significant prostate cancer."
Of the nearly 2 million prostate biopsies performed each year, less than a third find cancer. Most of these men could have avoided a painful and invasive prostate biopsy procedure, with its associated complications and costs. 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 harbouring aggressive, potentially lethal, prostate cancer who may benefit most from a prostate biopsy and earlier detection. The test delivers a negative predictive value (NPV) of 98% for clinically significant disease, helping to reduce unnecessary MRI procedures and invasive prostate biopsies by approximately 50%, thereby reducing healthcare costs.
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 gene methylation (epigenetic) and other molecular technologies 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.
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Dr. Jan Groen, CEO
US: +1 949 812 6979
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Amber Fennell, Chris Welsh, Hendrik Thys (PR & IR)
Consilium Strategic Communications
UK: +44 20 3709 5701
US: +1 917 322 2571 (Rx Communications Group LLC)
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.
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English MDxHelth PR European Urology April 2016 http://hugin.info/137314/R/2005954/741089.pdf
Source: MdxHealth (TM)