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 first module of the premarket approval (PMA) application for its stool DNA colorectal cancer screening test.
This module was comprised of the required documentation regarding the manufacturing and quality control systems for the product. The modules that remain to be submitted will include analytical and clinical data.
"The submission of the first, manufacturing module of our PMA application is an important milestone for the company," said Kevin T. Conroy, the company's president and chief executive. "With work on the first module finished, we are focused on completing and submitting the analytical and clinical modules."
The manufacturing module was submitted to the FDA on December 7, and the FDA has up to 45 days to accept the submission.
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]