EANS-Adhoc: Ad hoc Announcement Pursuant to § 15 WpHG (German Securities Trading Act): Epigenomics AG Completes U.S. Clinical Validation Study for Colorectal Cancer Blood Test Epi proColon; Provides Update on U.S. Regulatory Plans
09.12.2011 – 15:03
-------------------------------------------------------------------------------- ad-hoc disclosure pursuant to section 15 of the WpHG transmitted by euro adhoc with the aim of a Europe-wide distribution. The issuer is solely responsible for the content of this announcement. -------------------------------------------------------------------------------- New Products/molecular diagnostics 09.12.2011 Berlin, Germany, December 9, 2011 - Epigenomics AG (ISIN: DE000A1K0516) reports the completion of the clinical validation study for its second-generation colorectal cancer blood test Epi proColon in the U.S. The study was designed to measure the clinical performance of Epi proColon for the detection of colorectal cancer in comparison to colonoscopy and is part of the required data package to seek regulatory approval of the product in the U.S. In the reported study, Epi proColon detected 68% of the colorectal cancer cases (sensitivity) while correctly identifying 80% of the patients free of disease (specificity). While the results of the study represent the lower end of the expected performance data, the findings of the study confirm the results obtained in a previously conducted clinical study with the first generation of the company's Epi proColon test in the same cohort of patients. Study subjects tested were selected from a prospectively collected cohort of 7.940 individuals, defined as being at average risk for colorectal cancer by current screening guidelines and who underwent colonoscopy for colorectal cancer screening. The tested study cohort included 45 cancer cases. All plasma samples selected were blinded, randomized, and tested with Epi proColon at three independent laboratories in the U.S. After consultation with the U.S. Food and Drug Administration (FDA), the company confirmed that the clinical data would be assessed as part of the regular Premarket Approval (PMA) review process. The Company will begin the regulatory process with the FDA by submitting the first module of its PMA this month. In addition to the clinical validation study data, Epigenomics will also perform a head-to-head comparative study for colorectal cancer detection through comparison with fecal immunochemical testing (FIT) for the purpose of demonstrating non-inferiority of Epi proColon to FIT. This study will also become an integral part of the PMA submission to the FDA and is anticipated to be completed in 2012. - 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. Further inquiry note: Antje Zeise | CIRO Manager IR/PR Epigenomics AG Tel: +49 30 24345 386 antje.zeise@epigenomics.com end of announcement euro adhoc -------------------------------------------------------------------------------- issuer: 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: regulated dealing/prime standard: Frankfurt, free trade: Berlin, Hamburg, Stuttgart, Düsseldorf, München language: English