Epigenomics receives FDA notification

11-Jan-2016 - Germany

Epigenomics announced that the U.S. Food and Drug Administration (FDA) has informed the Company that the already submitted and available data for Epigenomics' blood-based colorectal cancer (CRC) screening test Epi proColon(R) would allow the agency to come to a final determination on its safety and effectiveness. Given that no new data would be required before reaching a final decision on the premarket approval ("PMA") submission, FDA would expect that final stages of the review process would be completed in the near future.

According to the FDA, final approval of the Company's application is subject to the resolution of minor outstanding topics, such as the use of appropriate language in the product labeling.

Epigenomics will work closely with the FDA to reach the final approval decision within the next few months.

Upon approval, Epi proColon(R) would be the first and only FDA-approved blood-based test for the detection of colorectal cancer. Epi proColon(R) will be made available in the United States jointly with the Company's strategic commercialization partner Polymedco.

https://www.bionity.com/en/news/156271/epigenomics-receives-fda-notification.html