Exact Sciences has submitted the second module of premarket application (PMA) of its noninvasive stool DNA colorectal cancer screening test to the US Food and Drug Administration (FDA).
The module included 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.
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 added.
"All of us are focused on completing work on the clinical trial and making our final submission."
The company said in the third and final module, it will include clinical data from its DeeP-C trial.