IRVINE, CA, and HERSTAL, BELGIUM – May 15, 2014 – MDxHealth SA (NYSE Euronext: MDXH), a leading molecular diagnostic company that develops and commercializes epigenetic tests to improve the diagnosis and treatment of cancer patients, today announced that results from its pivotal clinical validation study for ConfirmMDx® for Prostate Cancer will be highlighted in two oral presentations and separately, the test will be featured in a prostate cancer biomarker symposium at the upcoming American Urology Association 2014 Annual Meeting in Orlando, Florida.
The first two presentations will be delivered by Alan Partin, MD, PhD, Professor and Chief of Urology at the James Buchanan Brady Urological Institute at Johns Hopkins School of Medicine. Dr. Partin will present results of the multicenter DOCUMENT (Detection of Occult Cancer Using Methylated Events in Negative Tissue) validation study. The DOCUMENT study validates the ConfirmMDx for Prostate Cancer test as the most significant predictor of risk for the presence of occult cancer above any other risk factor used to guide the decision for repeat biopsy today. The study further validates that the ConfirmMDx test provides actionable information to improve patient risk stratification men and aid urologists to differentiate prostate-cancer-free men who may avoid unnecessary repeat biopsies from those who may harbor undetected prostate cancer and who merit early repeat biopsy. The first presentation will be an oral presentation at a satellite symposium of the AUA hosted by British Association of Urologic Surgeons International/Urological Society of Australia and New Zealand. The second presentation is part of a moderated poster Session at the AUA entitled “Prostate Cancer: Detection & Screening”. The prostate cancer biomarker symposium, which is supported by the Prostate Conditions Education Council, will review the clinical utility of several promising molecular tests, and will feature ConfirmMDx for Prostate Cancer.
International Society Session at the AUA: British Association of Urologic Surgeons (BAUS) / BJU International (BJUI) / Urological Society of Australia and New Zealand (USANZ)
Title: Prostate Cancer Tissue Methylation as a Marker for Repeat Biopsy – Update on MATLOC and DOCUMENT Trials
Presented by: Alan Partin, MD, PhD
Date: Sunday, May 18th, 2014
Time: 1:30 – 5:00pm
Location: Hyatt Regency: Regency BR P
Prostate Cancer: Detection & Screening III Moderated Poster Session at AUA
Title: Multicenter Validation Study of a Tissue Methylation Assay to Predict Histopathologically Cancer-Negative Repeat Prostate Biopsies
Presented by: Alan Partin, MD, PhD
Date: Monday, May 19th ,2014
Time: 3:30 – 5:30pm
Location: OCCC: W307 Orange County Convention Center
Clinical Update on Novel Prostate Cancer Biomarkers
Title: Biomarkers In Prostate Cancer: Navigating the Diagnostic & Prognostic Utility
Presented by: E. David Crawford, M.D., Head Section of Urologic Oncology, Professor of Urology, Surgery and Radiation Oncology, University of Colorado School of Medicine, Denver, Colorado and Neal D. Shore, M.D., FACS, Director, CPI, Carolina Urologic Research Center, Grand Strand Urology/Atlantic Urology Clinics, Myrtle Beach, South Carolina
Date: Tuesday, May 20th, 2014
Time: 10:00 – 11:00am
Location: Industry Clinical Update Theater (Booth #1369) Exhibit Hall
Over 975,000 American men receive a negative prostate biopsy result each year, though approximately 25% of these men may still harbor occult prostate cancer. This well-documented risk of undetected cancer, often with clinically significant Gleason scores, leads to a high rate of repeat biopsies with greater than 40% of men receiving at least one repeat biopsy, and many receiving a 3rd and 4th biopsy. Today’s gold standard diagnostic approach is the prostate biopsy procedure, collecting 10-12 needle core biopsy samples; however this sampling represents less than 1% of a man’s prostate. ConfirmMDx for Prostate Cancer is an epigenetic assay to help urologists distinguish patients who have a true-negative biopsy from those at risk for occult cancer. The test is able to detect an epigenetic field effect or “halo” associated with the cancerization process at the DNA level. This molecular “halo” around a cancer lesion can be present despite having a normal appearance under the microscope. The test helps urologists rule out prostate cancer-free men from undergoing unnecessary repeat biopsies and rule in high-risk patients who may require repeat biopsies and potential treatment. Performance of the proprietary ConfirmMDx genes and technology has been published in 42 studies with over 4,100 patients tested.
MDxHealth is a molecular diagnostics company that develops and commercializes advanced epigenetic tests for cancer assessment and the personalized treatment of patients. MDxHealth helps to address a large and growing unmet medical need for better cancer diagnosis and treatment information. The company has a proprietary platform and a strong epigenetic product pipeline focused on the development of products for prostate, brain, bladder and lung cancers. For more information visit www.mdxhealth.com and follow us on Twitter at: twitter.com/mdxhealth.
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