NEW YORK (GenomeWeb News) – Epigenomics today announced it has submitted the first module of its premarket approval application for the second generation of its colorectal cancer screening test to the US Food and Drug Administration.
The first module for the Epi proColon test was submitted on Dec. 30, 2011 and includes documentation on the manufacturing and quality controls section related to the test. Additional modules are expected to be submitted to FDA during the current and second quarters. The final module, which will include all clinical data, is scheduled for submission during the second half of 2012, the company said.
FDA provides for a 90-day review period for each module.
For its clinical module, Epigenomics will need to demonstrate that Epi proColon performs at least as well as fecal immunochemical testing, it said, adding that it has been in discussions with FDA about the design for its clinical study, which it expects to initiate in the coming months after the study's protocol has been finalized.
The clinical module for the PMA submission will include results of the head-to-head comparison with fecal immunochemical testing, previously announced data from a clinical validation study in a cohort of prospectively collected samples, and other clinical study results.
Last month, the Berlin, Germany-based molecular diagnostics firm announced clinical validation study results for the test. The test demonstrated 68 percent sensitivity and 80 percent specificity.