MDxHealth SA, a leading molecular diagnostic company that develops and commercializes epigenetic tests to support cancer treatment, and PLUS Diagnostics today announced that they have entered into an agreement to co-promote MDxHealth’s ConfirmMDxTM for Prostate Cancer test in the United States.
PLUS Diagnostics, a leading U.S. anatomic pathology company that offers a full range of multi- specialty services, will build awareness of ConfirmMDx for Prostate Cancer, through its national network of urologists. ConfirmMDx for Prostate Cancer is a laboratory-developed test (LDT), performed at MDxHealth’s Irvine, California laboratory that assists urologists with identifying men who may safely forego unnecessary repeat biopsies.
“We are excited to combine forces with one of the leading anatomic pathology providers in the U.S. PLUS Diagnostics is highly regarded for its extensive pathology expertise and premier testing services, and has built strong relationships with urologists. The national reach afforded by PLUS Diagnostics provides a direct channel into the urology community and will aid in meeting the growing demand for our test,” said Dr. Jan Groen, CEO of MDxHealth.
“Our company is dedicated to providing our customers with the highest quality tests and services that meet their unique needs for diagnosing and treating their patients. We are impressed with the support of key opinion leaders from prominent academic institutions and the body of published scientific evidence that MDxHealth has generated. We believe this test will improve the standard of care for patients with negative prostate biopsies,” said David Pauluzzi, CEO of PLUS Diagnostics.
About ConfirmMDx for Prostate Cancer
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 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 a proven 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 safely forego unnecessary repeat biopsies.
The company expects to launch ConfirmMDx for Prostate Cancer in Q2 2012. MDxHealth and PLUS Diagnostics will begin co-promoting the test immediately.
Please visit the companies at the American Urology Association Annual Meeting, May 19-23 2012 in Atlanta, GA, booths #3831 and #3923.
About PLUS Diagnostics
PLUS Diagnostics (plusdx.com) is a leading national pathology company that provides a full range of multi-specialty services, including extensive diagnostic procedures and specialist consultations. Accredited by the College of American Pathologists, PLUS Diagnostics has long been recognized for exceptional service and quality. The company currently focuses on a broad base of specialty pathology services, including urology, gastroenterology and hematology/oncology. PLUS Diagnostics is a company of Water Street Healthcare Partners.
MDxHealth (mdxhealth.com) 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. Follow us on Twitter at: twitter.com/mdxhealth.
Dr Jan Groen will make a formal presentation on the Company at the 13th annual meeting BioEquity Europe that is taking place on May 15th-16th in Frankfurt, Germany.
For more information:
Mike Sinclair, Halsin Partners
UK: +44 20 7318 2955 / Cell: +44 7968 022075
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.