Exact Sciences Corp, Madison, Wis, a molecular diagnostics company focused on the early detection and prevention of colorectal cancer, has submitted to the FDA the second module of the premarket approval (PMA) application for its stool DNA colorectal cancer screening test.
This module was comprised of the required studies and documentation establishing the analytical performance of the screening test on known samples, including analytical sensitivity and specificity, cross-reactivity, and other similar studies. The third and final module will include clinical data from the company’s DeeP-C trial.
A modular PMA submission is one in which the contents of a PMA are broken into several clearly defined parts or modules. These modules are submitted separately over time and comprise a complete PMA when all of them have been completed. The FDA reviews each module as it’s received, which may allow for more rapid closure of the application.
[Source: Exact Sciences Corp]
