EANS-News: Epigenomics AG / Epigenomics AG Reports Non-Inferiority of Blood-based Epi proColon® against Fecal Immunochemical Testing in Detection of Colorectal Cancer in a Head-to-Head Comparative Stu

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Research & Development/Research & Development/molecular diagnostics

Berlin, Germany, and Seattle, WA, U.S.A. (euro adhoc) - Press release

Epigenomics AG Reports Non-Inferiority of Blood-based Epi proColon®
against Fecal Immunochemical Testing in Detection of Colorectal
Cancer in a Head-to-Head Comparative Study

Berlin, Germany, and Seattle, WA, U.S.A., December 04, 2012 -
Epigenomics AG (Frankfurt Prime Standard: ECX), the German-American
cancer molecular diagnostics company, today announced top-line
results from a head-to-head comparative study between its blood-based
colorectal cancer (CRC) detection test Epi proColon® and fecal
immunochemical testing (FIT) to demonstrate the non-inferiority of
Epi proColon® in detection of CRC.

Dr. Thomas Taapken, Chief Financial Officer and acting Chief
Executive Officer of Epigenomics, commented: "Based on the achieved
non-inferiority in CRC detection, we believe that Epi proColon® has
demonstrated its value to be a convenient non-invasive test
alternative for CRC detection. Bringing a blood-based non-invasive
product like Epi proColon® to the market will significantly drive
awareness for colorectal cancer screening among individuals that
would otherwise be noncompliant, since current compliance to FIT
testing remains at low levels."

In the reported trial, Epi proColon® detected 73 in a total of 103
evaluable samples from patients with colorectal cancer, which
represents a sensitivity of 71%. The FIT comparator used in the
study, one of the most commonly used FIT products in the US market,
detected 66 out of 98 cancer cases for which stool samples were
provided, translating into a sensitivity of 67%. Based on
Epigenomics' analysis of the data, which was confirmed by an external
party, the Company met the critically important endpoint of
non-inferiority with respect to sensitivity of Epi proColon® to FIT.
These results represent an important milestone for Epigenomics and
will be part of the final module of the Premarket Approval (PMA)
submission expected to be filed with the U.S. Food and Drug
Administration (FDA) before the end of this year.

The double blind study was performed at 70 clinical trial sites
across the US and comprised two arms. The first arm included a total
of 103 asymptomatic, average risk individuals without family history
or previous incidences of CRC, who were diagnosed and confirmed as
having colorectal cancer during a screening colonoscopy. Matched
blood and stool samples from these patients were collected at least
10 days after colonoscopy but before surgical intervention. The
second arm of the study included 198 individuals selected according
to the same criteria, but whose blood and stool samples were
collected before the colonoscopy. This study arm included three
cancer cases as well as advanced adenomas, polyps and individuals
with no evidence of disease. Based on all non-CRC samples from the
second arm, specificity for Epi proColon® was determined at 81% and
for FIT at 98%. These findings are in line both with previous studies
on Epi proColon® and published data for FIT. In summary, Epigenomics
met the critically important sensitivity endpoint, which provides the
potential to discover more CRC patients. The difference in
specificity was anticipated and in the Company's opinion is less
vital, since patients will undergo a colonoscopy -the currently
recommended screening procedure- as a result of a positive test
result. Testing of all samples was performed strictly according to
the instructions for use by the respective manufacturers of both
tests at an independent third party testing laboratory in the US,
which was blinded to the samples analyzed.

Dr. Uwe Staub, Chief Operating Officer of Epigenomics, commented:
"These positive study results confirm the performance of our assay
and indicate that Epi proColon® is non-inferior to FIT in the
detection of CRC. We look forward to an active dialogue with the
agency upon completion of our PMA filing before the end of this
year."

The company plans to submit detailed study results for presentation
at a medical meeting and for peer-reviewed publications in the near
future.

Conference call for press and analysts

Epigenomics' management will host a conference call and an audio
webcast at 5pm CET/11am ET today, Tuesday 4th December 2012.

The dial-in numbers for the conference call are:
Dial-in number (within Germany): + 49 69 247501899

Dial-in number (within the UK): + 44 203 1474861

Dial-in number (within the U.S.): + 1 212 4440297

Participants are kindly requested to dial in 10 minutes prior to the
start of the call.

The presentation accompanying the conference call and dial-in details
for the audio webcast will be available on Epigenomics' website:
{http://www.epigenomics.com/en/news-investors.html}[HYPERLINK:
http://www.epigenomics.com/en/news-investors.html]

A webcast of the conference call will be provided on Epigenomics'
website subsequently:
{http://www.epigenomics.com/en/news-investors.html}[HYPERLINK:
http://www.epigenomics.com/en/news-investors.html] - Ends -

Contact Epigenomics AG

Antje Zeise
Manager IR | PR
Epigenomics AG
Tel +49 (0) 30 24345 368
ir@epigenomics.com
www.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 disclaimer 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.

Further inquiry note:
Antje Zeise | CIRO
Manager IR/PR
Epigenomics AG
Tel: +49 30 24345 386

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