Epigenomics AG Successfully Validates Optimized Blood-Based Colorectal Cancer Assay in two Independent Clinical Studies

Performance of Septin 9 assay optimized for clinical routine
application confirmed as equivalent to earlier research assay - Blood
test successfully run in more than 500 additional patient samples

Berlin, Germany, and Seattle, WA, U.S.A., April 21, 2008 -
Epigenomics AG (Frankfurt Prime Standard: ECX), a molecular
diagnostics company focusing on the development and commercialization
of products for cancer based on DNA methylation, today announced that
it successfully validated a technically improved assay and an
enhanced testing algorithm for its colorectal cancer biomarker,
Septin 9, in two independent clinical case control studies. The
studies confirmed that the assay optimized for routine molecular
diagnostic laboratory use detects colorectal cancer in blood plasma
statistically equivalent to the previously used research assay.

The first prospective case control study (269 subjects) tested blood
samples from 97 patients with, and 172 individuals without,
colorectal cancer as confirmed by colonoscopy. The new assay detected
72 of 97 cancer cases (74% sensitivity) and only 14 of 172
individuals without disease (false positive rate of 8% or 92%
specificity). The second case control study, composed of an entirely
independent set of blood plasma samples from 249 subjects, confirmed
the performance observed in the first study. In this study the new,
optimized assay identified 63 of 91 colorectal cancer patients of all
stages (69% sensitivity) and only 17 of 158 patients without
colorectal cancer (89% specificity). In these two independent
studies, the performance of the new assay was statistically
equivalent to the performance of the research assay previously used
in a 2006 study of over 300 subjects, which demonstrated a
sensitivity of 72% at a specificity of 90%.

Detailed results of both studies will be presented by Cathy
Lofton-Day, PhD, VP Molecular Biology at Epigenomics Inc., at the
upcoming Biomarker World Congress 2008 in Philadelphia, PA, USA, May
19 - 21, 2008 and at the upcoming AACR special conference "Cancer
Epigenetics" in Boston, MA, USA, May 28 - 31, 2008.

The improved assay marks a significant milestone towards the
development and commercialization of Septin 9 DNA methylation
biomarker assays, as it provides a reference for the development of
Septin 9 based diagnostic products for colorectal cancer. Technical
improvements of the assay used in these two studies included a
simplified sample handling process and a significant shortening in
handling time resulting in a doubling of sample throughput per lab
technician. Most importantly, the assay costs could be reduced by 65%
and the DNA extraction and the biomarker assay processing are now
compatible with widely available laboratory automation solutions.
Epigenomics also developed an enhanced and robust algorithm to
interpret Septin 9 DNA methylation as a biomarker for colorectal
cancer. These improvements position the assay for a potential
application to a mass screening approach.

"We considerably simplified our Septin 9 assay, making it
significantly cheaper and compatible with laboratory automation
solutions. We have repeatedly demonstrated the excellent ability of
the Septin 9 biomarker to detect colorectal cancer in blood plasma
with high sensitivity and specificity and we found that these data
are highly consistent across several independent studies. This
clearly demonstrates the robustness of our DNA methylation technology
and the Septin 9 biomarker which now has proven its performance in
more than 3,500 patient samples," commented Geert Nygaard, Chief
Executive Officer of Epigenomics.

As a next step in Epigenomics' program for the development of a blood
based colorectal cancer screening test, the company aims at
demonstrating that Septin 9 performance satisfies the requirements of
the most recent U.S. screening guidelines for colorectal cancer and
demonstrates a benefit in a validated health economic model. To this
end the company plans to initiate PRESEPT, a multi-center and
international study to characterize Septin 9 clinical performance and
health economic benefits in a U.S. colorectal cancer screening
guideline-eligible population. The study is planned to commence in Q2
2008 and will include up to 7,500 average and increased risk
individuals, professional society guideline-eligible to receive
screening colonoscopy.

About Colorectal Cancer Screening and the Septin 9 Biomarker

Colorectal cancer is the second leading cause of cancer related
death. With a 5-year-survival rate of above 90 percent if diagnosed
at an early stage, early detection through blood based testing would
be valuable. This type of test targets almost 300 million people in
Europe, the U.S., and Japan, a market that is worth more than USD 3
billion in total. The gold standard screening test is colonoscopy, an
invasive procedure, whereby the physician visually inspects the
inside of the colon. This procedure, which has excellent specificity
and sensitivity characteristics, not only identifies cancer but also
pre-cancerous lesions known as adenomas. Due to the nature of this
procedure and its high cost, it is not widely used at short
intervals. A non-invasive first-line test therefore would be useful
to screen individuals at risk so that they then undergo colonoscopy.
Currently, most non-invasive screening is carried out with the Fecal
Occult Blood Testing (FOBT) procedure using stool samples. However,
due to the inconvenient nature of the test, the compliance rate is
comparatively low. The introduction of a more convenient,
patient-friendly test could potentially increase the number of
individuals tested. If positive, the patients would be followed up by
colonoscopy. This could increase the chances of the disease being
caught early with the goal of reducing mortality from colorectal
cancer.

Epigenomics' technology aim at sensitively detecting DNA based on
specific DNA methylation patterns in blood plasma samples or other
body fluids. The Septin 9 gene encodes a protein involved in cell
division and is thought to play a role in the onset of cancer.
Epigenomics has demonstrated in multiple clinical case control
studies with over 3,500 samples from colorectal cancer patients,
healthy controls, and patients with non-cancerous colon diseases that
methylated DNA of Septin 9 shed by tumors into the blood stream can
serve as a biomarker for the sensitive and specific detection of
colorectal cancer. As a first strategic partner, Abbott Molecular,
Inc. licensed the worldwide non-exclusive IVD rights to Epigenomics'
proprietary Septin 9 biomarker for colorectal cancer. In addition,
Quest Diagnostics Inc., the leading provider of diagnostic testing,
information and services, obtained the license to commercialize a
laboratory-developed test (LDT) for Septin 9 in the U.S.

About DNA Methylation

DNA methylation is a natural and tightly controlled biological
process that serves the regulation of genes and the stability of the
human genome. Cytosine, one of the four bases in DNA, can be modified
by the covalent addition of a methyl group. DNA methylation in gene
regulatory regions (i.e. gene promoters) helps control gene activity.
Every cell type has its unique DNA methylation "fingerprint" that
changes in various normal biological processes and in many diseases,
in particular cancer. DNA methylation thus provides a rich source for
highly specific biomarkers for organ-specific disease diagnosis,
classification and prediction for therapeutic intervention.

About Epigenomics AG

Epigenomics is a molecular diagnostics company with a focus on the
development of novel products for cancer. Using DNA methylation
biomarkers, Epigenomics' tests can potentially diagnose cancer at an
early stage and thereby may reduce mortality from this dreaded
disease.

The company develops diagnostic screening tests for the early
detection of cancer. Based on body fluid samples (e.g. blood and
urine), these tests are aimed at finding cancer at an early stage
before symptoms occur. Epigenomics' product pipeline contains a
validated biomarker for the early detection of colorectal cancer in
blood plasma, and further proprietary DNA methylation biomarkers at
various stages of development for prostate and lung cancer detection
in body fluids. For development and global commercialization as in
vitro diagnostic test kits, Epigenomics pursues a non-exclusive
partnering strategy with diagnostics industry companies. As a first
strategic partner, Abbott Molecular Inc. licensed the worldwide
non-exclusive IVD rights to Epigenomics' proprietary Septin 9
biomarker for colorectal cancer. Epigenomics also aims at giving
patients and doctors early access to these biomarkers through
reference laboratory testing services. As a first reference
laboratory partner, Quest Diagnostics Inc., the leading provider of
diagnostic testing, information and services, obtained the license to
commercialize a laboratory-developed test (LDT) for Septin 9 in the
U.S.

Partners in the health care industry and the biomedical research
community can access Epigenomics' portfolio of proprietary DNA
methylation technologies and biomarkers protected by more than 150
patent families through research products, Biomarker Services, IVD
Development Collaborations, and Licensing. The company is
headquartered in Berlin, Germany, and has a wholly owned subsidiary
in Seattle, WA, U.S.A. For more information, please visit
Epigenomics' website at www.epigenomics.com.

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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.

Contact

Epigenomics AG
Dr. Achim Plum
SVP Corporate Development
+49 30 24345 368 (phone)
+49 30 24345 555 (fax)
achim.plum@epigenomics.com
www.epigenomics.com