EANS-News: Epigenomics AG Reports Conclusions from PRESEPT Study Audit

Differences in analytical instrument read-out requires verification
and potential retesting of samples measured in laboratory with
deviating results

Top-line data expected still in Q1 2010

No
impact on commercial strategy expected

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Research & Development/Molecular Diagnostics/Products

Subtitle: Differences in analytical instrument read-out requires
verification and potential retesting of samples measured in
laboratory with deviating results

Top-line data expected still in Q1 2010

No impact on commercial strategy expected

Press release, Berlin, Germany, and Seattle, WA, U.S.A., February 4,
2010 (euro adhoc) - Epigenomics AG (Frankfurt, Prime Standard: ECX),
a cancer molecular diagnostics company, today reported the
conclusions from the investigation into the results from one of the
three laboratories that were used to test samples of the PRESEPT
Study cohort.

The investigation had been initiated by the Clinical Study Steering
Committee (CSSC) following the reporting of preliminary results of
the PRESEPT Study on January 15, 2010. These preliminary findings
indicated that in two of the three testing laboratories that
performed Septin9 testing on blood plasma samples from the PRESEPT
Study, subjects achieved cancer detection rates of 62.5% each and
therefore were well within expectations. The third laboratory
reported a cancer detection rate of 28% which deviated from the
findings in the other testing laboratories and all previous eight
case control studies on the biomarker that in total included more
than 3,300 plasma samples from cancer patients and control subjects.
(Refs 1-3)

The thorough audits of the testing laboratories revealed that the
analytical instrument used in the laboratory with the divergent
results was a recently released new version of the device that was
unique to this study laboratory. In the other two laboratories, a
different instrument version was used. The audit team observed that
the instrument which generated the lower than expected cancer
detection rate reported unusually high fluorescence signals in
several runs which could have impacted the read-out of results. Those
signals could originate from the sample containers used on that
device and/or the device itself. This observation was not made in any
of the two other laboratories nor any previous study by Epigenomics.
The audits at all three testing laboratories, Epigenomics' internal
processes as well as the biostatistics group at the University of
Minnesota performed as part of the investigation did not identify
significant deviations related to sample traceability, sample
handling, or sample processing which could explain the observed
results.

Epigenomics will verify the cause for the observed high fluorescent
signals and generate data to demonstrate whether and how far this
could be responsible for the results observed in the lower cancer
detection rate. If necessary, the company will retest study subject
samples that were potentially affected by this incident.

In addition to the further investigation into the lower cancer
detection rate in the one laboratory and following the
recommendations of the CSSC, a small number of additional cancer
cases will be tested. These cancer cases were confirmed by pathology
after shipping the last testing batches to the laboratories in
December. The CSSC had stipulated the testing of these samples in the
original study plan to include the results in the final data set to
be submitted to a peer-reviewed scientific journal for publication.
The company still expects that all further testing and retesting of
samples can be completed within Q1 2010. The company plans to release
the updated top-line results from the study including the additional
and repeated testing results once they become available.

"We are fully on track in executing on the commercialization of our
already launched colorectal cancer blood test, the Epi proColon
product", commented Geert Nygaard, Chief Executive Officer of
Epigenomics. "It is important to realize that the PRESEPT Study is an
academic medicine study. Its results remain entirely independent of
the regulatory pathway such as future FDA approvals and clearances of
our Epi proColon product, Abbott's mS9 assay, or Quest's ColoVantage
test in any current or future market." Further information

Conference Calls

Epigenomics' management has scheduled a conference call for today,
February 04, 2010 at 14:00 CET (German language) and 17:00 CET/11:00
am EST (English language) to update on findings in the investigation
of outlier results in the PRESEPT Study and planned corrective
actions as well as answering questions from investors and media. The
dial-in numbers for the conference call are:

Dial-in number (within Germany): +49 (0)69 247 501 899
Dial-in number (within US): +1 212 444 0297

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

A recording of the conference call will be provided on Epigenomics'
website subsequently: {http://www.epigenomics.com/en/down_loads/corpo
rate_material/}[HYPERLINK:
http://www.epigenomics.com/en/down_loads/corporate_material/]

References

1. Lofton-Day C, et al. DNA methylation biomarkers for blood-based
colorectal cancer screening. Clin Chem. 2008;54(2):414-23. 2.
Grützmann R, et al. Sensitive detection of colorectal cancer in
peripheral blood by mSEPT9 DNA methylation assay. PLoS One.
2008;3(11):e3759. 3. deVos T, et al. Circulating methylated SEPT9 DNA
in plasma is a biomarker for colorectal cancer. Clin Chem.
2009;55(7):1337-46.

About Epigenomics

Epigenomics 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 aim
at diagnosing cancer at an early stage before symptoms occur and
thereby may reduce mortality from this dreaded disease.

Epigenomics' product portfolio contains the CE-marked IVD test Epi
proColon®, the world's first regulatory cleared molecular diagnostic
test for the detection of colorectal cancer in blood that is based on
the biomarker Septin9, and further proprietary DNA methylation
biomarkers and IVD products at various stages of development for
colorectal, lung and prostate cancer. 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, Philips,
Sysmex Corporation, Quest Diagnostics Incorporated, and ARUP
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, U.S.A. For more
information, please visit Epigenomics' website at
{www.epigenomics.com}[HYPERLINK: http://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.

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 in the
United States. 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. have not been established.

end of announcement euro adhoc
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ots Originaltext: Epigenomics AG
Im Internet recherchierbar: http://www.presseportal.de

Further inquiry note:

Epigenomics AG

Dr. Achim Plum

Sen. VP Corporate Development

Tel: +49 30 24345 368

achim.plum@epigenomics.com

Branche: Biotechnology
ISIN: DE000A0BVT96
WKN: A0BVT9
Index: Prime All Share, Technology All Share
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