Epigenomics announces initiation of PMA filing for Epi proColon

06-Jan-2012 - Germany

Epigenomics AG announced that it has submitted the first module of its premarket approval (PMA) submission to the US Food and Drug Administration (FDA) on December 30, 2011.

On December 30, 2011 Epigenomics has initiated the process of gaining US regulatory approval of its colorectal cancer (CRC) screening test Epi proColon® by submitting the first module of its modular PMA approval submission to the FDA. The first module of the submission includes all required documentation on the manufacturing and quality controls section in relation to the product. Further modules are scheduled to be submitted throughout the first and second quarters of 2012 and the final module, including all clinical data is scheduled for submission in the second half of 2012. Under the FDA’s modular PMA submission protocol, in its guidance document “Guidance for Industry and FDA staff – Premarket Approval Application Modular Review”, the FDA provides for a 90 day review period by the agency for each individual module.

As previously announced, a head-to-head comparative study with the goal of demonstrating non-inferiority of Epi proColon® to fecal immunochemical testing (FIT) will be an integral part of the clinical module. The design of the clinical study has been discussed with the FDA and upon finalizing of the study protocol, it will be initiated in the coming months. The clinical module of the PMA submission will encompass the results of the head-to-head comparative study, previously announced data from a clinical validation study in a cohort of prospectively collected samples and other clinical study results generated during the development of Epi proColon®.

https://www.bionity.com/en/news/135802/epigenomics-announces-initiation-of-pma-filing-for-epi-procolon.html