MDxHealth Licensee Exact Sciences Receives FDA Panel Recommendation for Approval of Colorectal Cancer Screening Test

MDxHealth Licensee Exact Sciences Receives FDA Panel Recommendation for Approval of Colorectal Cancer Screening Test  MDxHealth's Epigenetic Biomarker Used in Cologuard Test  IRVINE, CA, and HERSTAL, BELGIUM, March 28, 2014 (GLOBE NEWSWIRE) -- 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 the Molecular and Clinical Genetics Panelof theUnited States Food and Drug Administration's (FDA) Medical Devices Advisory Committee strongly endorsed approval of Cologuard(TM). The Committee determined by a unanimous vote of 10 to zero that Exact Sciences has demonstrated safety, effectiveness and a favorable risk benefit profile of Cologuard, the company's stool-based DNA (sDNA), non-invasive colorectal cancer screening test. Cologuard incorporates one of MDxHealth's epigenetic biomarkers and methylation specific PCR (MSP) technology, which was licensed to Exact Sciences in July 2010.  "Colorectal cancer is the second leading  cause of cancer death inthe  United  States yet often viewed as the most preventable," stated Dr. Jan Groen, CEO of MDxHealth. "We are very proud to see that one of our epigenetic biomarkers is a key component of the biomarker panel incorporated in the Cologuard screening test."  Cologuard is  designed to  detect specific  changes in  a patient's  DNA  that  appear in the stool, which could indicate the presence of colorectal cancer or pre-cancerous polyps. The test also identifies  the presence of blood in  the  stool, another indicator of possible colorectal cancer.  "We are pleased the Committee  strongly supported Cologuard's approval,"  said  Kevin T. Conroy,  chairman and chief  executive of Exact  Sciences. "We  look  forward to  continuing  our  work with  the  FDA  to complete  its  review  of  Cologuard and  remain  committed to  addressing  the growing  unmet  needs  in  colorectal cancer screening. We thank the FDA and its advisory committee  for  its careful consideration of Cologuard. We also appreciate the opportunity to participate in the innovative FDA/CMS parallel review program."  Cologuard is an investigational device currently under review by the U.S. Food and Drug Administration  (FDA) and  is not available  for sale  in the  United  States. The Committee's  recommendation will be  taken into consideration  by  the FDA in its final  review of the Cologuard test.  The FDA is not bound  by  the Committee's guidance but often follows this expert guidance.  About MDxHealth  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  validated to help distinguish  patients who have  a  true-negative biopsy from those who may have undetected cancer, thereby aiding in the reduction of unnecessary repeat biopsies. 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,  bladder and lung  cancers. For more  information visit www.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 len@allencaron.com info@mdxhealth.com  msinclair@halsin.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.  To access the PDF version, please click here http://hugin.info/137314/R/1772409/603849.pdf  HUG#1772409  
Press spacebar to pause and continue. Press esc to stop.