Epigenomics AG / Key word(s): Study/Miscellaneous 24.04.2014 12:10 Dissemination of an Ad hoc announcement according to § 15 WpHG, transmitted by DGAP - a company of EQS Group AG. The issuer is solely responsible for the content of this announcement. --------------------------------------------------------------------------- Berlin (Germany), Germantown, MD, and Newark, CA (U.S.A.), Beijing (China), April 24, 2014 - Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), and BioChain Institute Inc. (BioChain), today announced that BioChain has completed its major clinical validation study to validate Epigenomics' blood-based Septin9 screening assay Epi proColon(R) for the early detection of colorectal cancer (CRC) with the goal to gain market approval for the test in China. In addition, BioChain has officially submitted an application to the China Food and Drug Administration (CFDA) in April for the approval of Epi proColon(R). Both companies expect commercialization of the test in China to start in 2015. The clinical validation study was designed to evaluate the clinical performance of Epi proColon(R) for the detection of CRC and is part of the required data package to seek regulatory approval in China. From November 2013 to March 2014, a total of 1,074 patients at three top ranking hospitals in China were tested by using Epigenomics' Epi proColon(R) 2.0 CE assay. Epi proColon(R) detected 74.8% of the cancer cases (sensitivity) and correctly identified 97.4% of the patients free of disease (specificity). The tested study cohort included 300 cancer cases in stages I to IV. The results were marked as positive when at least two out of three samples of the test triplicate were evaluated as positive. The results were in line with those achieved in Epigenomics' European CE marking study reported in 2011, which followed the same principle of data interpretation (80% sensitivity and 99% specificity). - End of Ad hoc - Contact Epigenomics AG Antje Zeise CIRO Manager IR | PR Epigenomics AG Phone: +49 (0) 30 24345 386 ir@epigenomics.com www.epigenomics.com Epigenomics' legal disclaimers. 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. 24.04.2014 DGAP's Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.dgap-medientreff.de and www.dgap.de --------------------------------------------------------------------------- Language: English Company: Epigenomics AG Kleine PräsidentenstraÃe 1 10178 Berlin Germany Phone: +49 30 24345-0 Fax: +49 30 24345-555 E-mail: ir@epigenomics.com Internet: www.epigenomics.com ISIN: DE000A1K0516 WKN: A1K051 Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr in Berlin, Düsseldorf, München, Stuttgart End of Announcement DGAP News-Service ---------------------------------------------------------------------------
DGAP-Adhoc: Ad hoc Announcement Pursuant to § 15 WpHG (German Securities Trading Act): Epigenomics' Partner BioChain Successfully Completes Clinical Validation Study for CFDA Approval of Epi proColon(R) in China
| Source: EQS Group AG