Berlin, Germany, and Seattle, WA, U.S.A., February 21, 2013 - Epigenomics AG (Frankfurt
Prime Standard: ECX), the German-American cancer molecular diagnostics company, announced
today that the United States Food & Drug Administration (FDA) accepted its Premarket
Approval (PMA) application for Epi proColon®. The agency concluded that all information
needed for the substantive review is included and has granted priority review status to the
application. Epi proColon® is Epigenomics’ blood-based test for the detection of colorectal
In December 2012, Epigenomics successfully completed its head-to-head comparative study.
Subsequently, the PMA submission was submitted to FDA by the end of that year. The
application is now under substantive review by the agency.
Dr. Thomas Taapken, Chief Financial Officer and acting Chief Executive Officer of
Epigenomics, commented: “After the encouraging results from our final clinical trial and the
completion of our PMA submission late last year, we are very pleased that the agency has filed
the application and has granted the priority review status to the application. We are now
anticipating a productive dialog with FDA. While we await the final decision from the regulators,
we continue to actively plan for commercialization. We look forward to potentially being able to
bring the advantages of this convenient blood-based testing alternative for CRC to the benefit of
patients in the US.”
Contact Epigenomics AG
Manager IR | PR
Tel +49 (0) 30 24345 368
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®, is a blood-based test for the early detection
of colorectal cancer, which is currently marketed in Europe and is in development for the U.S.A.
The Company’s technology and products have been validated through multiple partnerships with
leading global diagnostic companies including Abbott, QIAGEN, Sysmex, and Quest
Diagnostics. Epigenomics is an international company with operations in Europe and the U.S.A.
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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 by
Epigenomics in the United States or Canada. The analytical and clinical performance
characteristics of any Epigenomics product based on this technology which may be sold at some
future time in the U.S. have not been established.