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
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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.
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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.comwww.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
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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