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MDxHealth SA (NYSE Euronext: MDXH), a leading molecular diagnostic company that develops and commercializes epigenetic tests to support cancer treatment, today announced the launch of ConfirmMDx™ for Prostate Cancer, a novel test that helps urologists distinguish patients who have a true-negative prostate biopsy from those who may have occult cancer. Testing will be performed in MDxHealth's state-of-the-art Irvine-based CLIA laboratory for physicians submitting prostate tissue samples directly or via its exclusive co-marketing partner PLUS Diagnostics.
"As many as one in four men could be misdiagnosed due to limitations with current prostate biopsy procedures, commonly described as 'sampling error'. As a consequence, the standard of care for men with persistently high-risk factors, but no evidence of prostate cancer in a biopsy, is limited to continued surveillance and repeat biopsies, often on prostate-cancer-free men. The ConfirmMDx for Prostate Cancer test detects epigenetic changes associated with the presence or absence of prostate cancer," explained Prof Dr. Wim van Crienkinge, Chief Scientific Officer of MDxHealth.
"The launch of ConfirmMDx for Prostate Cancer represents the culmination of extensive research and development efforts and demonstrates the commitment of the MDxHealth team to deliver on its new commercial strategy," said Dr. Jan Groen, CEO of MDxHealth. "MDxHealth is uniquely positioned with its portfolio of epigenetic assays to capitalize on the realization of true personalized medicine, improving patient care, while reducing healthcare costs."
Over 650,000 American men receive a negative prostate biopsy result each year; however approximately 25-35% of these results are false negative. Under the current standard of care, prostate biopsy procedures collect 10-12 needle biopsy cores on average, effectively sampling less than 1% of a man's prostate. This approach leaves men at risk of occult cancer, leading to a high rate of repeat biopsies, often on prostate-cancer-free men. There is an unmet medical need for a clinically effective diagnostic test to address this dilemma. ConfirmMDx for Prostate Cancer is an epigenetic assay to help distinguish patients who have a true-negative biopsy from those at risk for occult cancer. The test helps urologists rule out prostate cancer-free men from undergoing unnecessary repeat biopsies and, helps rule in high risk patients who may require repeat biopsies and potential treatment. The test is able to detect an epigenetic field effect or "halo" associated with the cancerization process at the DNA level in cells adjacent to cancer foci. This molecular "halo" around a cancer lesion can be present despite having a normal appearance under the microscope. Thus ConfirmMDx for Prostate Cancer aids urologists in identifying men who may forego unnecessary repeat biopsies.
Please visit MDxHealth and PLUS Diagnostics at the American Urology Association Annual Meeting, May 19-23 2012 in Atlanta, GA, booths #3831 and #3923.
MDxHealth is a molecular diagnostics company that develops and commercializes advanced epigenetic tests for cancer assessment and the personalized treatment of patients. By applying patented DNA methylation platform and biomarkers, MDxHealth helps to address a large and growing unmet medical need for better cancer diagnosis and treatment information.
Tags: clinical trials