FDA’s molecular and clinical genetics panel is tentatively scheduled to review Exact Sciences’ premarket approval application (PMA) for the Cologuard colorectal cancer screening test on March 26, 2014. The company submitted its application for the stool-DNA-based, noninvasive test on June 7, 2013. Confirmation of the meeting is still pending.
As part of the approval process, Exact Sciences conducted a 90-site trial surveying 10,000 patients—one of the most exhaustive colorectal studies conducted in the United States. The Cologuard test, which measures the presence of mutated DNA in cells shed by precancerous polyps, demonstrated 92% sensitivity in identifying colon cancer. According to the American Cancer Association, colon cancer is currently the third leading cause of cancer deaths in the United States. For more information, visit Exact Sciences.