Exact Sciences Corp. (Nasdaq: EXAS) today announced that it has submitted to the U.S. Food and Drug Administration 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.
“Our submission of the second module marks the latest successful step towards completing our PMA submission to the FDA,” said Kevin T. Conroy, the company’s president and chief executive. “The successful completion of this and other milestones would not be possible without the outstanding team at Exact. All of us are focused on completing work on the clinical trial and making our final submission.”
The analytical module was submitted to the FDA on Friday, Feb. 15.
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.
About Exact Sciences Corp.
Exact Sciences Corp. is a molecular diagnostics company focused on the early detection and prevention of colorectal cancer. The company has exclusive intellectual property protecting its noninvasive, molecular screening technology for the detection of colorectal cancer. Stool-based DNA technology is included in the colorectal cancer screening guidelines of the American Cancer Society and the U.S. Multi-Society Task Force on Colorectal Cancer. For more information, please visit the company’s website at
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