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Epigenomics AG

EANS-News: Epigenomics Provides Update on Progress with US Product Development for Epi proColon

Berlin, Germany, and Seattle, WA, USA, January 13, 2011 (euro adhoc) -

- Strong feasibility study data for improved product concept with 91%
sensitivity and 87% specificity
- FDA sets February date for Pre-IDE meeting
  Corporate news transmitted by euro adhoc. The issuer/originator is solely
  responsible for the content of this announcement.
New Products/Molecular diagnostics
Subtitle: - Strong feasibility study data for improved product concept with 91%
  sensitivity and 87% specificity
- FDA sets February date for Pre-IDE meeting
Epigenomics AG (Frankfurt Prime Standard: ECX), the cancer molecular diagnostic
company, today announced that it has concluded the feasibility phase in the
development of an improved product concept for Epi proColon, the Company´s DNA
methylation-based blood test for assistance in the detection of individuals with
colorectal cancer. This improved product concept is being developed for the US
market and as a second generation product for the European and other markets. At
the same time, the FDA has set a date in February for a Pre-IDE meeting to
discuss with Epigenomics the product concept, its intended use and the clinical
data required to support an application for marketing of the product in the US.
Epi proColon is currently marketed in Europe and a number of other countries
outside the USA and its utility in the early detection of colorectal 
cancer in a blood draw is extensively supported by numerous clinical 
studies. While the new assay measures the same epigenetic information
in the Septin9 gene, design changes have been implemented that are 
based on the findings in the more recent studies performed by 
Epigenomics and its partners as well as feedback from current 
customers in Europe and market surveys in the US. The new device will
use reagents manufactured under the cGMP standard and a real-time PCR
platform that has previously been cleared by the FDA for use with 
diagnostic assays. Performing the assay will require fewer components
and handling steps and results can be obtained within a typical 
laboratory work shift of 8 hours. Further, the new assay will have 
improved automation capabilities.
In a feasibility study that included 97 colorectal cancer patients 
and 159 colonoscopy-confirmed controls in the improved assay had a 
sensitivity for cancer of 91% at 87% specificity. In this study, the 
test was able to identify 22 out of 27 Stage I cancer cases (78%) and
25 out of 25 Stage II cancer cases (100%). This is particularly 
important as patients with Stage I and II of colorectal cancer have a
combined five year survival of about 90% and early clinical 
interventions are effective in improving survival.
Dr. Uwe Staub, Senior Vice President Product Development at 
Epigenomics said: "The excellent results of this feasibility study 
are a direct reflection of the improvements we have made to the test.
Following our upcoming dialogue with the FDA, we hope to be able to 
finalize our clinical validation plan for the intended use of the 
improved test and later this year run the pivotal study using the 
samples already collected as part of the prospectively enrolled 
PRESEPT cohort. It should be noted that the higher proportion of pT1 
subgroup of Stage I cases may mean that the sensitivity in a 
prospective evaluation would not be as high as we have just seen in 
the feasibility study."
Geert Nygaard, Chief Executive Officer of Epigenomics added: "We are 
delighted to have this confirmation that the improvements and 
adaptations we made to the assay should result in a product that 
meets USFDA as well as European regulatory and market requirements 
but also shows potentially improved clinical performance. We are 
looking forward to our upcoming discussions with the FDA, which 
commence shortly. Once those discussions conclude in the period 
following our face-to-face meeting we will be in the position to 
provide more detail on the next steps towards launching our Epi 
proColon test in the US."
The Company also intends to make the improved next generation Epi 
proColon product available in Europe and other markets once it has 
been adapted to the LightCycler 480 as well as the AB7500 instruments
currently used in these markets. The second generation product is 
likely to reach these markets by during the second half of 2011.
-Ends-
Contact Epigenomics AG
Dr. Achim Plum
Sen. VP Corporate Development
Epigenomics AG
Tel +49 (0) 30 24345 368 
pr@epigenomics.com
www.epigenomics.com
About Epigenomics
Epigenomics AG is a molecular diagnostics company with a focus on the
development of novel products for cancer. Using DNA methylation 
biomarkers, Epigenomics´ tests on the market and in development for 
colorectal, lung, and prostate cancer aim at aiding in an earlier and
more accurate diagnosis of these diseases, thereby potentially 
increasing the patient´s chances of survival.
For development and global commercialization of IVD test products, 
Epigenomics pursues a dual business strategy in which direct 
commercialization of proprietary diagnostic test products is combined
with non-exclusive licensing to diagnostic industry players with 
broad customer access. Strategic diagnostics industry partners 
include Abbott Molecular, Sysmex Corporation, Quest Diagnostics 
Incorporated, ARUP Laboratories, Inc., and Warnex Laboratories, Inc. 
for diagnostics test products and services, and QIAGEN N.V. for 
sample preparation solutions and research products.
The company is headquartered in Berlin, Germany, and has a wholly 
owned subsidiary, Epigenomics Inc., in Seattle, WA, USA. For more 
information, please visit Epigenomics´ website at 
www.epigenomics.com.
About Epi proColon
Epi proColon, developed by Epigenomics, is a test for the detection 
of methylated DNA of the Septin9 gene in blood plasma. Detection of 
this Septin9 biomarker in blood plasma has been shown in numerous 
clinical studies to be closely associated with the presence of 
colorectal cancer and may aid in the detection of this common cancer.
Septin9 is one of the best and most systematically validated 
biomarkers for the early detection of colorectal cancer today. In 
particular, the recent PRESEPT Study was a successful prospective 
evaluation of Epi proColon detection of methylated Septin9 in a 
cohort of about 8,000 individuals representative of a typical 
screening population.
Lack of patient adherence to screening recommendations is the biggest
hurdle to an effective screening for colorectal cancer. Experts 
believe that a blood test that is more convenient for the patients 
than stool tests and colonoscopy could help to get more people 
screened and thus be of medical and health economic benefit.
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.
end of announcement                               euro adhoc

Further inquiry note:

Dr. Achim Plum
Sen. VP Corporate Development
Epigenomics AG
Tel: +49 30 24345 368
achim.plum@epigenomics.com

Branche: Biotechnology
ISIN: DE000A0BVT96
WKN: A0BVT9
Index: Prime All Share, Technology All Share
Börsen: Frankfurt / regulated dealing/prime standard
Berlin / free trade
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München / free trade

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