IRVINE, CA, and LIEGE, BELGIUM – May 13, 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 a co-marketing agreement with American Pathology Partners to promote its ConfirmMDx® for Prostate Cancer test. American Pathology Partners is creating a nationwide network of leading anatomic pathology laboratories, with UniPath in Denver, Colorado, Palm Beach Pathology in West Palm Beach, Florida and Eastern Carolina Pathology in Wilson, North Carolina. The partnership expands MDxHealth’s customer base to some of the nation’s leading pathologists who serve urologists in key geographic markets within the United States.
“Collaborating with leading pathology networks like American Pathology Partners is an integral component of our growth strategy,” noted Dr. Jan Groen, CEO of MDxHealth. “As the urology community learns more about the clinical utility of ConfirmMDx for patient management decisions, increased access through valuable strategic partners is essential to deliver improved care to a larger number of patients.”
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 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.
About American Pathology Partners
American Pathology Partners is an emerging nationwide network of leading anatomic pathology laboratories serving physician offices, hospitals, and surgery centers. Founded in early 2008, APP provides academic-caliber medical consults and interpretation services through its affiliated pathologists. APP’s board-certified pathologist partners have extensive training and experience in numerous subspecialty areas, including surgical pathology, cytopathology, dermatopathology, hematopathology, urologic pathology, gastrointestinal and liver pathology, nephropathology, pediatric and perinatal pathology, immunopathology, and molecular diagnostics. Additional information can be found at www.AP2.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 | Mike Sinclair | Len Hall |
| MDxHealth | Halsin Partners | Allen & Caron, Inc |
| US : +1 949 812 6979 | UK: +44 20 7318 2955 | US: +1 949 474 4300 |
| BE: +32 4 364 20 70 | Cell: +44 7968 022075 | |
| info@mdxhealth.com | msinclair@halsin.com | len@allencaron.com |
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.
NOTE: The MDxHealth logo, MDxHealth, ConfirmMDx and PredictMDx are trademarks or registered trademarks of MDxHealth SA. All other trademarks and service marks are the property of their respective owners.
