EXACT Sciences Corporation Submits First Module of Premarket Approval Application to FDA
Published: Dec 11, 2012
MADISON, Wis.--(BUSINESS WIRE)--Exact Sciences Corp. (Nasdaq: EXAS) today announced that it has submitted to the U.S. Food and Drug Administration 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 Friday, Dec. 7. The FDA has up to 45 days to accept the submission.