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Epigenomics AG Provides Update on Regulatory Status and Information on Additional Clinical Study for Epi proColon(R) in the U.S. - Seite 2
setting. The Company remains committed to study the performance of its
blood-based test in a programmatic setting after potential approval in the
context of a post-marketing study as previously proposed in its PMA
application. Based on initial estimates, Epigenomics expects additional
costs for the study to be in the range of less than EUR 1.0 million.
Dr. Thomas Taapken, CEO/CFO of Epigenomics, commented: "After a productive
dialogue with the FDA, we now have a better understanding of the issues and
background of the agency's assessment. We are confident that we can
complete the requested clinical study within a reasonable period of time.
Although Epigenomics is currently able to fund these additional activities,
we are constantly evaluating various options to maintain the Company's
financial flexibility and to allow for the preparation of commercialization
in the U.S. in order to rapidly enter the market post approval."
The discussed clinical study was requested as part of the FDA response
letter in relation to Epigenomics' PMA application for the Company's
blood-based colorectal cancer screening test Epi proColon(R) the Company
received at the beginning of June 2014.
- End -
Contact Epigenomics AG
Antje Zeise, Manager IR | PR
Epigenomics AG
Kleine Praesidentenstrasse 1
10178 Berlin
Tel +49 (0) 30 24345 386
ir@epigenomics.com
www.epigenomics.com
For U.S. press inquiries:
Epigenomics, Inc.
20271 Goldenrod Lane, Suite 2027
Germantown, Maryland 20876
pr@epigenomics.com
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
its tissue assay for use in lung cancer diagnosis, Epi proLung(R), in
Europe. The Company's technology and products have been validated through
multiple partnerships with leading global diagnostic companies and testing
laboratories. Epigenomics is an international company with operations in
Europe and the U.S.A.
Epigenomics legal 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
letter in relation to Epigenomics' PMA application for the Company's
blood-based colorectal cancer screening test Epi proColon(R) the Company
received at the beginning of June 2014.
- End -
Contact Epigenomics AG
Antje Zeise, Manager IR | PR
Epigenomics AG
Kleine Praesidentenstrasse 1
10178 Berlin
Tel +49 (0) 30 24345 386
ir@epigenomics.com
www.epigenomics.com
For U.S. press inquiries:
Epigenomics, Inc.
20271 Goldenrod Lane, Suite 2027
Germantown, Maryland 20876
pr@epigenomics.com
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
its tissue assay for use in lung cancer diagnosis, Epi proLung(R), in
Europe. The Company's technology and products have been validated through
multiple partnerships with leading global diagnostic companies and testing
laboratories. Epigenomics is an international company with operations in
Europe and the U.S.A.
Epigenomics legal 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
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