EANS-News: Epigenomics AG Enrolls First Participant in its FIT comparative study
with Epi proColon®
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Corporate news transmitted by euro adhoc. The issuer/originator is solely
responsible for the content of this announcement.
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Company Information/New Products/molecular diagnostics
Berlin, Germany, and Seattle, WA, U.S.A., April 11, 2012 (euro adhoc) -
Epigenomics AG (Frankfurt Prime Standard: ECX), the German-American cancer
molecular diagnostics company, today announced the start of the head-to-head
comparative study of Epi proColon® with fecal immunochemical testing (FIT) for
colorectal cancer detection. Meanwhile the first study subject has been
enrolled.
As previously announced, the US Food and Drug Administration (FDA) has requested
Epigenomics to perform a head-to-head comparative study for colorectal cancer
detection through comparison with FIT for the purpose of demonstrating
non-inferiority of Epi proColon® to FIT.
Site recruitment and initiation is currently ongoing with the aim of including
up to 75 clinical sites. The study will compare FIT and Epi proColon® analyses
for 100 subjects with confirmed cancer (post colonoscopy) and 200 asymptomatic
average risk individuals (pre-colonoscopy). Epigenomics plans to complete this
study in the second half of 2012 and the results will be an integral part of the
company's Modular Premarket Approval (PMA) submission to the FDA. The Company
already submitted the first two PMA modules and is on track to file its third
and fourth modules in the second quarter and second half of 2012, respectively.
-Ends-
Contact Epigenomics AG
Antje Zeise Manager IR | PR
Epigenomics AG
Tel +49 (0) 30 24345 386
ir@epigenomics.comwww.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 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 of America.
The analytical and clinical performance characteristics of any product based on
this technology which may be sold at some future time in the U.S.A. have not
been established.
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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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