Review of New Biomarkers in Prostate Cancer

IRVINE, CA, and HERSTAL, BELGIUM — 8:00 AM, February 24, 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 the ConfirmMDx® for Prostate Cancer test was highlighted as one of several key advances in biomarker technology that aims to transform detection of prostate cancer and its subsequent management.  In a review published in the February 2014 issue of ONCOLOGY, leading urologists, E. David Crawford, MD, Neal D. Shore, MD and co-author Karen Ventii, PhD, explain how an explosion in genomic analysis and interpretation of prostate cancer tissue has enabled discovery of new biomarkers, their integration into clinical practice, and clinical management of the disease.

Over 975,000 American men have a negative prostate biopsy each year; however approximately 25-35% of those men receive false-negative results. Under the current standard of care, prostate biopsy procedures consisting of 10-12 needle biopsy cores only sample approximately 1% of a man’s prostate.  This approach leaves men at risk for undetected cancer, leading to a high rate of repeat biopsies, often on cancer-free men.  There is an unmet medical need for a clinically effective diagnostic test to address this dilemma.  ConfirmMDx for Prostate Cancer detects an epigenetic field effect or ‘halo’ associated with the presence of cancer at the DNA level. This “halo” around a tumor can be detected in prostate cells despite having a normal appearance under the microscope. Thus ConfirmMDx for Prostate Cancer aids urologists in identifying truly negative men who may forego an unnecessary repeat biopsy procedure.

“In the last few years, several new genomic biomarkers have emerged that can help guide clinicians on when to biopsy, whom to re-biopsy, and how to assist patients in their treatment decisions,” explained E. David Crawford, M.D, head of Urologic Oncology at the University of Colorado.  “One such exciting test is ConfirmMDx for Prostate Cancer, an epigenetic assay to help distinguish patients who have a true-negative biopsy from those who may have occult cancer. This test aids in improved risk stratification and allows us to reduce unnecessary repeat biopsies on men at low risk for prostate cancer.”

“Prostate cancer biomarkers should assist the clinician in improving risk assessment, reducing overtreatment, and providing more selective therapy for patients with high-risk disease,” noted Neal D. Shore, Medical Director of the Carolina Urologic Research Center, Myrtle Beach, South Carolina. “With new biomarkers like ConfirmMDx being integrated into the clinic, we are seeing clinical decision-making impact on patient care.”

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