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Epigenomics AG: Epigenomics AG Announces Publication of Results of Two U.S. Clinical Studies with its Blood-based Epi proColon(R) CRC Screening Test - Seite 2

detecting patients with CRC was 73% versus 68% for FIT. Specificity of Epi
proColon(R) was 82% versus 97% for FIT. The study results confirm the
performance of the assay and indicated that Epi proColon(R) met the
critically important endpoint of non-inferiority with respect to
sensitivity to the state-of-the-art FIT test in detecting CRC.

"We are very pleased to see that the clinical results of these U.S. studies
with our blood-based Epi proColon(R) CRC screening test now have been made
publicly available. This is of particular importance as payors,
policymakers, medical societies and guideline bodies will rely on this
information for their decision-making process," explained Dr. Thomas
Taapken, CEO/CFO of Epigenomics. "Since participation in CRC screening
programs remains suboptimal, we are convinced that a blood-based test like
Epi proColon(R) could significantly increase participation rates,
considering that blood-testing is routine and well accepted for many other
health conditions."

The Company initially completed the PMA filing for Epi proColon(R) approval
in early 2013 and received a response letter from the U.S. Food and Drug
Administration (FDA) in June 2014. The main item stressed in the response
letter revolved around the need for additional data clearly demonstrating
that Epi proColon(R) will increase compliance to CRC screening in the
intended use population, i.e. in those patients who today do not undergo
CRC screening by guideline recommended methods such as colonoscopy or FIT.
The Company is currently in dialog with the FDA to learn more about the
background of the agency's assessment and will work diligently to amend the
PMA application accordingly in order to ensure an appropriate path forward
towards U.S. market approval.

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Contact Epigenomics AG

Antje Zeise, Manager IR | PR
Epigenomics AG
Kleine Praesidentenstrasse 1
10178 Berlin
Tel [phone]
[e-mail]
www.epigenomics.com

For U.S. press inquiries:
Epigenomics, Inc.
20271 Goldenrod Lane, Suite 2027
Germantown, Maryland 20876
[e-mail]


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(R), is a blood-based test for the
early detection of colorectal cancer, which is currently marketed in Europe
and is under regulatory review by the FDA for the U.S.A. and the Chinese
Food and Drug Administration for China. Additionally, the Company markets