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Epigenomics AG Submits the Fourth Module and Completes Its PMA Submission to the FDA for Epi proColon®



1/7/2013 11:39:04 AM

Berlin, Germany, and Seattle, WA, U.S.A., January 7, 2013 - 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."

Contact Epigenomics AG

Antje Zeise

Manager IR | PR

Epigenomics AG

Tel +49 (0) 30 24345 368

ir@epigenomics.com

www.epigenomics.com


Read at BioSpace.com


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