Exact Sciences, a healthcare products manufacturer based in Madison, Wisconson, announced that it had filed the first of three premarket approval applications (PMA) for its colorectal cancer screening system. The screening system uses DNA sequencing from stool samples to determine the presence of cancer.
Kevin Conroy is CEO and president at Exact Sciences. In prepared remarks, he said, “The submission of the first manufacturing module of our PMA application is an important milestone for the company.” He continued, "With work on the first module finished, we are focused on completing and submitting the analytical and clinical modules."
The first module includes documentation on manufacturing and quality control during fabrication of the device. The next two PMAs will include clinical and analytical data on the efficacy of the device.
Modular PMA submissions are those in which a traditional PMA are broken into several different parts. Once all the modules are submitted, they will comprise a completed PMA. Since modular PMA submissions give the FDA the ability to review each module as it is submitted, this process may allow for faster clearance of a device.
Exact Sciences provides molecular diagnostic products for the detection of colorectal cancer. Stool-based DNA screening technologies are included in guidelines created by the U.S. Multi-Society Task Force on Colorectal Cancer and the American Cancer Society.
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