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News Breaks | | | | February 18, 2013 | | 10:34 EDT |  | EXAS | Exact Sciences submits second module of premarket approval application to FDA
Exact Sciences 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.” | |
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| May 7, 2013 | | 07:24 EDT |  | EXAS | Mizuho Securities to host a conference
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