Epigenomics AG Receives Notification of Priority Review Status and Acceptance for Filing by FDA of PMA Application for Epi proColon®
Published: Feb 21, 2013
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.”
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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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