IRVINE, CA, and HERSTAL, BELGIUM – July 2, 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 it has entered into an agreement with Miraca Life Sciences (MLS), the nation’s largest independent anatomic pathology lab, to promote MDxHealth’s ConfirmMDx® for Prostate Cancer test. Serving more than 5,500 patients each day, Miraca Life Sciences is a national leader in providing academic-caliber pathology services in the fields of dermatology, hematology, gastroenterology and urology.
“Miraca Life Sciences has established its impeccable reputation on the ability to deliver timely, accurate and actionable diagnoses to clinicians and their patients. Delivering the right answer is largely based upon the quality of available medical information,” said Dr. Frank Basile, President and CEO of MLS. “Through this strategic partnership with MDxHealth, we can now offer a well-validated epigenetic assay, which delivers new molecular insights on a patient’s risk for undetected cancer, thereby enabling our clients make more informed decisions about the need for a repeat prostate biopsy.”
“We are very excited about our strategic partnership with Miraca Life Sciences which provides Miraca’s clinicians and their patients with access to ConfirmMDx, and allows us to support their efforts to deliver the highest quality patient care,” said Dr. Jan Groen, CEO of MDxHealth. “Miraca Life Sciences is an excellent partner given their services extend across a variety of medical specialties, potentially opening new channels for additional tests currently in our product pipeline.”
About ConfirmMDx® for Prostate Cancer
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 undetected 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.
About Miraca Life Sciences
Miraca Life Sciences specializes in the development and commercialization of the highest quality academic pathology services, primarily in the fields of dermatology, hematology, gastroenterology and urology. The company’s core team of more than 90 academic-caliber specialists utilizes state-of-the-art pathology laboratories currently headquartered in Irving, Texas, and throughout the United States to serve more than 5,500 patients every day. Through rigorous quality assurance, daily and monthly conferences, and close relationships with clinical partners, Miraca Life Sciences continuously improves diagnostic precision. For more information visit http://www.miracalifesciences.com.
MDxHealth is a leading molecular diagnostic company that develops and commercializes epigenetic tests to support cancer treatment. The company’s tests are based on proprietary gene methylation (epigenetics) 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.
For more information:
|Dr. Jan Groen, CEO
|US: +1 949 812 6979
|UK: +44 20 7318 2955
|BE: +32 4 364 20 70
|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. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of MDxHealth in any jurisdiction. No securities of MDxHealth may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. securities laws.
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