Exact Sciences (EXAS) Submits PMA to FDA for Cologuard
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Exact Sciences Corp (Nasdaq: EXAS) 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.
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 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.
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 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.
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