EANS-News: Epigenomics AG
Epigenomics AG submits the fourth module and
completes its PMA submission to the FDA for Epi proColon®
07.01.2013 – 08:33
-------------------------------------------------------------------------------- Corporate news transmitted by euro adhoc. The issuer/originator is solely responsible for the content of this announcement. -------------------------------------------------------------------------------- Company Information/molecular diagnostics Berlin, Germany, and Seattle, WA, U.S.A. (euro adhoc) - Epigenomics AG (Frankfurt Prime Standard: ECX), the German-American cancer molecular diagnostics company, announced today that it has submitted the fourth and final module of its Premarket Approval (PMA) to the United States Food & Drug Administration (FDA) for its blood-based Epi proColon® test for the detection of colorectal cancer in December 2012 as previously indicated, thereby completing its submission to the FDA. The fourth module of the PMA contained the clinical data generated with the test, including the results of the recently reported head-to-head comparative study of Epi proColon® to FIT, previously announced data from a clinical validation study in a cohort of prospectively collected samples and other clinical study results generated during the development of Epi proColon®. Thomas Taapken, Chief Financial Officer and acting Chief Executive Officer of Epigenomics commented: "The non-inferiority of Septin9 to FIT demonstrated by the results of the head-to-head comparative study that were announced in December 2012 was a very important milestone for us. We are very pleased that we were able to complete the submission of the PMA to the FDA by year end 2012, meeting our previously announced guidance. We continue to believe that our test is as effective as other non-invasive tests currently used with the added convenience of being a blood test, which will help drive screening compliance and therefore save more lives." - Ends - Contact Epigenomics AG Antje Zeise Manager IR | PR Epigenomics AG Tel +49 (0) 30 24345 368 ir@epigenomics.com www.epigenomics.com About Epigenomics Epigenomics (www.epigenomics.com) is a molecular diagnostics company developing and commercializing a pipeline of proprietary products for cancer. The Company's products enable doctors to diagnose cancer earlier and more accurately, leading to improved outcomes for patients. Epigenomics' lead product, Epi proColon®, is a blood-based test for the early detection of colorectal cancer, which is currently marketed in Europe and is in development for the U.S.A. The Company's technology and products have been validated through multiple partnerships with leading global diagnostic companies including Abbott, QIAGEN, Sysmex, and Quest Diagnostics. Epigenomics is an international company with operations in Europe and the U.S.A. Epigenomics legal disclaimer This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale by Epigenomics in the United States or Canada. The analytical and clinical performance characteristics of any Epigenomics product based on this technology which may be sold at some future time in the U.S. have not been established. Further inquiry note: Antje Zeise | CIRO Manager IR/PR Epigenomics AG Tel: +49 30 24345 386 end of announcement euro adhoc -------------------------------------------------------------------------------- company: Epigenomics AG Kleine Präsidentenstraße 1 D-10178 Berlin phone: +49 30 24345-0 FAX: +49 30 24345-555 mail: ir@epigenomics.com WWW: http://www.epigenomics.com sector: Biotechnology ISIN: DE000A1K0516 indexes: Prime All Share, Technology All Share stockmarkets: free trade: Berlin, München, Hamburg, Düsseldorf, Stuttgart, regulated dealing/prime standard: Frankfurt language: English