Molecular diagnostics company Exact Sciences has filed the second module of a premarket application (PMA) seeking approval from the US Food and Drug Administration (FDA) for its noninvasive stool DNA colorectal cancer screening test.
The module included documentation and study data establishing the analytical performance of the screening test on known samples, including analytical sensitivity and specificity, cross-reactivity and other similar studies.
Exact Sciences president and chief executive Kevin Conroy said the submission of the second module marks the latest successful step towards completing its PMA submission to the FDA.
"The successful completion of this and other milestones would not be possible without the outstanding team at Exact," Conroy said.
"All of us are focused on completing work on the clinical trial and making our final submission."
The company will include clinical data from its DeeP-C trial in the third and final module.
With exclusive intellectual property protection, the stool-based DNA technology is included in the colorectal cancer screening guidelines of the American Cancer Society and the US Multi-Society Task Force on Colorectal Cancer.