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MDxHealth Announces Publication of the Clinical Utility of Combining Genetics and Epigenetics to Improve Management of Prostate


MDxHealth Announces Publication of the Clinical Utility of Combining Genetics and Epigenetics to Improve Management of Prostate Cancer

IRVINE, CA and LIEGE, BELGIUM -- (Marketwired) -- 04/03/13 -- MDxHealth SA (EURONEXT BRUSSELS: MDXH), a leading molecular diagnostic company that develops and commercializes epigenetic tests to support cancer treatment, today announced the publication of the clinical utility of epigenetic diagnosis to improve the management of prostate cancer. The results were published in the Journal of Oncopathology 2013;1:29-32.

In this publication, researchers from the University of Gent, Johns Hopkins and MDxHealth reported on the imminent shift towards sequencing-based diagnostic technologies utilized in obtaining a clinical diagnosis of prostate cancer anticipated in the near future. Profiling and integrating genetic and epigenetic aberrations that are implicated in prostate cancer will allow for rapid identification and development of molecular diagnostic assays. By directing efforts toward the selection of known epigenetic and genomic targets, an immediate improvement tool in the diagnosis, treatment and long-term management of these patients can be expected (http://www.oncopathology.doctors.md/Vol1IssueI.html).

"Technological advances in the field of sequencing are redefining the era of personalized disease profiling," noted Prof Dr. Wim van Criekinge, Head of the Laboratory of Bioinformatics and Computational Genomics at the University of Gent. "Previously, profiling was limited to one modality of gene regulation, e.g. the identification of somatic mutations, without considering other changes that are occurring concomitantly. Now genomic and epigenomic profiles of all, or a very large set of, genes known to be implicated in the onset of cancer, disease progression or the prediction of therapeutic efficacy, regardless of their frequency of occurrence, can be determined simultaneously."

"Combining comprehensive, integrated, molecular profiles with clinical and therapeutic outcomes serves as a powerful, evidence-based method for the identification of biomarkers," stated Dr. Jan Groen, CEO of MDxHealth. "Applying next generation and targeted deep sequencing technologies, MDxHealth has developed tests that improve the diagnosis and tre atment of prostate cancer as well as other cancer types."

About ConfirmMDx(TM) for Prostate Cancer Over 650,000 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 over 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 in cells adjacent to cancer foci. 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 helps rule in high risk patients who may require repeat biopsies and potential treatment.

About MDxHealth(R) MDxHealth is a molecular diagnostics company that develops and commercializes advanced epigenetic tests for cancer assessment and the personalized treatment of patients. The company's first commercial product, ConfirmMDx for Prostate Cancer, has been shown to help distinguish patients who have a true-negative biopsy from those who may have undetected cancer. MDxHealth helps to address a large and growing unmet medical need for better cancer diagnosis and treatment information. The company has a proprietary platform and a strong epigenetic product pipeline focused on the development of products for prostate, brain and lung cancers. The company is based in Irvine, California with a European headquarters in Liege, Belgium. For more information visit MDxHealth's website at www.mdxhealth.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.

Click here for the PDF version: http://hugin.info/137314/R/1689481/554505.pdf

For more information:

Dr Jan Groen President and CEO MDxHealth US: +1 949 812 6979 BE: +32 4 364 20 70 info@mdxhealth.com

Mike Sinclair Halsin Partners UK: +44 20 7318 2955 Cell: +44 7968 022075 msinclair@halsin.com

Seth Lewis The Trout Group US: +1 646 378 2952 slewis@troutgroup.com

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