The United States Food & Drug Administration (FDA) has accepted Epigenomics' 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 cancer (CRC).
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.”
Epigenomics is a molecular diagnostics company developing and commercializing a pipeline of proprietary products for cancer.