600 Patient Study to Evaluate Emerging Technologies for Improved Selection of Patients for Prostate Biopsy
IRVINE, CA, and HERSTAL, BELGIUM, October 19, 2015 – MDxHealth SA (Euronext: MDXH), has entered into an agreement with Radboud University Medical Center in Nijmegen, The Netherlands, for the inclusion of the SelectMDx(TM) for Prostate Cancer test into the 4M prospective clinical study. The study is designed to evaluate the effectiveness of emerging technologies, including MRI and SelectMDx, for the improved selection of patients for prostate biopsy.
This prospective 4M clinical study on 600 subjects is designed to evaluate the effectiveness of emerging technologies for the improved selection of patients for prostate biopsy. MRI-guided biopsies have been reported to enable the identification potential prostate cancer lesions, allowing for targeted prostate biopsies, and improved accuracy of prostate cancer detection. SelectMDx, a non-invasive, urine-based “liquid biopsy” test, has been shown to improve patient risk stratification and can help reduce the number of unnecessary prostate biopsies. The study will evaluate the combination of SelectMDx and MRI procedures to establish more effective pathways for prostate cancer detection while minimizing the cost and morbidity associated with prostate biopsies.
Under the current standard of care, age, digital rectal examination (DRE) and Prostate Specific Antigen (PSA) are some of the common risk factors used to determine a man’s risk for prostate cancer and the need for a biopsy. The imprecision of these clinical measurements leads to a high rate of unnecessary prostate biopsies that are invasive and can lead to complications, while leaving some patients undiagnosed and at risk for disease progression.
“Given the recent controversy over PSA screening, and concerns about over diagnosis and treatment of prostate cancer patients, there is a well-defined need for better tools to diagnose and manage prostate cancer patients,” stated Prof. J.O. Barentsz MD PhD, principal investigator of the 4M study, at Radboud University Medical Center, Nijmegen, The Netherlands “We are eager to investigate the potential synergies of the SelectMDx test in combination with MRI. We want to know if the SelectMDx test can enhance patient selection for MRI-guided prostate biopsies, thereby optimizing resources, decreasing healthcare costs and improving patient outcomes.”
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 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.
Radboud university medical center is an institute for patient care, research and education & training, located in Nijmegen, the Netherlands. Our mission is to have a significant impact on healthcare. We aim to be a frontrunner in the development of innovative, sustainable and affordable healthcare. By offering excellent quality, participatory and personalized healthcare, operational excellence and sustainable networks. Our almost 10,000 employees and over 3,000 students do their utmost every day to make a positive contribution to the future of healthcare and medical sciences.
MDxHealth is a multinational healthcare company that provides actionable epigenetic information to personalize the diagnosis and treatment of cancer. The company’s tests are based on proprietary gene methylation (epigenetic) technology 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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