EANS-Adhoc: Epigenomics AG: PRESEPT Academic Research Study Meets Its Primary Objective

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Company Information/Molecular diagnostics/Studies

08.03.2010

Berlin, March 8, 2010 - Epigenomics AG (ISIN: DE000A0BVT96), a cancer
molecular diagnostics company, reports updated top-line PRESEPT Study
data showing that the Septin9 biomarker in this research study
detected colorectal cancer cases with a sensitivity of approximately
63% based on 32 colorectal cancer (CRC) cases correctly identified
out of 51 cancer cases with valid measurements of Septin9 in blood
plasma samples. With this performance the PRESEPT Study has met its
objective of detecting the majority of prevalent and incident cancers
in a screening cohort, a requirement for noninvasive screening tests
set forth in current joint guidelines by the American Cancer Society,
the US Multi-Society Task Force on Colorectal Cancer, and the
American College of Radiology (1). With a specificity of around 89%
the Septin9 testing result meets the targeted specificity range of
85% to 90%, which based on an initial health economic analysis,
should support public and private payer coverage and reimbursement.

As originally foreseen in the study protocol, the study results were
updated upon testing of samples determined to be invalid along with
testing of a small number of additional cancer cases identified after
the previous testing was initiated. Furthermore, investigative
actions were implemented after a preliminary data analysis in January
15, 2010 had indicated that one of the three laboratories performing
the Septin9 testing had reported a cancer detection rate that
deviated from findings in the other PRESEPT Study testing
laboratories and all previous studies. An investigation into these
results led to retesting potentially affected samples by the other
two labs. In addition a remainder of material leftover from
processing of the samples measured in the study was also tested for
Septin9 at each of the three independent laboratories and included
into the analysis. The combined results from all of the above testing
activities contributed to the improved test performance reported.

Epigenomics can now report that the additional testing directed by
the PRESEPT Clinical Study Steering Committee (CSSC) has been
completed, and the Committee has reported to Epigenomics that the
primary objective of the study of identifying the majority of
colorectal cancer cases has been successfully met. Although
histopathological review and further detailed statistical analysis
remain to be completed, the CSSC concludes the results are not
inconsistent with case-control studies previously reported (2-4) and
that the data indicate that Septin9 testing may be a useful tool to
detect the presence of occult colorectal cancer in a standard plasma
specimen obtained from average risk individuals eligible for
colorectal cancer screening. Later this year the CSSC will submit the
PRESEPT Study results for presentation at a major medical meeting and
peer-reviewed publication in a major scientific journal.

A simple blood test for colorectal cancer, which can be made
available to the large group of patients who are eligible for
colorectal cancer screening, but are unwilling or unable to use other
available methods, has the potential to address the lack of
compliance with today's screening approaches (5). Based on the
Septin9 performance data and the prevalence of CRC observed in the
PRESEPT Study cohort, a primary care physician informing a patient of
a Septin9 test result that is negative for colorectal cancer, can do
so with the certainty of it being correct 99.7% of the time (Negative
Predictive Value).

PRESEPT is a prospective multi-center clinical research study started
in 2008 to evaluate the performance characteristics and health
economic benefit of colorectal cancer screening using Epigenomics'
Septin9 blood test in a screening population. The PRESEPT Study is
one of the largest commercially sponsored colorectal cancer screening
clinical studies ever conducted. Between June 2008 and December 2009,
in total 7,941 screening eligible average risk subjects were enrolled
into the PRESEPT Study at 32 clinical sites in the U.S. and Germany.
This study population contained 53 cases of previously unsuspected
colorectal cancer that were identified by screening colonoscopies
performed on all study participants. Over two-thirds of the 53
colorectal cancer cases identified in the cohort were early stage
disease (Stages I and II) with a large proportion of the stage I
colorectal cancer cases being very early stage disease (so-called
pT1) as determined by pathology.

End of Ad Hoc Announcement
References

1. Levin B, et al., Screening and surveillance for the early
detection of colorectal cancer and adenomatous polyps, 2008: a joint
guideline from the American Cancer Society, the US Multi-Society Task
Force on Colorectal Cancer, and the American College of Radiology.
Gastroenterology 2008; 134(5): 1570-95. 2. Lofton-Day C, et al. DNA
methylation biomarkers for blood-based colorectal cancer screening.
Clin Chem. 2008; 54(2):414-23. 3. Grützmann R, et al. Sensitive
detection of colorectal cancer in peripheral blood by mSEPT9 DNA
methylation assay. PLoS One. 2008;3(11):e3759. 4. deVos T, et al.
Circulating methylated SEPT9 DNA in plasma is a biomarker for
colorectal cancer. Clin Chem. 2009; 55(7):1337-46. 5. The Centers for
Disease Control and Prevention (CDC) e.g. estimates that 40% of the
eligible population of adults 50 years of age or older —the age group
at greatest risk of developing colorectal cancer— in the USA has not
been screened appropriately.
{http://www.cdc.gov/cancer/colorectal/sfl/}[HYPERLINK:
http://www.cdc.gov/cancer/colorectal/sfl/]

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
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