Exact Sciences Corp. (Nasdaq: EXAS) today announced that it has submitted to the U.S. Food and Drug Administration the final module of the premarket approval (PMA) application for Cologuard™, the company's stool DNA (sDNA) colorectal cancer screening test. The final module, which is comprised of data from the company's DeeP-C clinical trial, completes the company's PMA application for the product.
“Maneesh is an invaluable partner who has been instrumental in developing the company's commercial strategy and is the best person to lead a successful launch of Cologuard”
The DeeP-C trial is one of the most extensive colorectal cancer screening studies ever conducted in the United States. It analyzed data from approximately 10,000 patients at 90 sites between the ages of 50 and 84 who were at average risk for colorectal cancer.
"The completion of our PMA submission to the FDA is the most significant milestone in the company's history and a big step forward in helping physicians make the battle against colorectal cancer a winning one," said Kevin T. Conroy, the company's president and chief executive. "I want to thank the tremendous team at Exact Sciences and our collaborators for their outstanding work. We share a passion for delivering our breakthrough colorectal cancer screening test to the physicians and patients who need it. Now, we look forward to continuing to work with the FDA through the review process."
The final module was submitted to the FDA on Friday, June 7.
A modular PMA submission is one in which the contents of a PMA are broken into 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 is received, which may allow for more rapid closure of the application.
The company will submit the DeeP-C study's pivotal data set for publication in a peer-reviewed journal, presentation at a major medical meeting or both.
The company also announced the expansion of Maneesh K. Arora's chief operating officer responsibilities to include the oversight of U.S. sales and marketing. The company is in the process of building out its commercial leadership team and is also conducting a search for a senior financial officer.
"Maneesh is an invaluable partner who has been instrumental in developing the company's commercial strategy and is the best person to lead a successful launch of Cologuard," Mr. Conroy said.
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