Exact Sciences has announced the FDA Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee unanimously voted to approve its stool-based DNA colorectal cancer screening test Cologuard.
In a 90-site trial of the test, Cologuard was found to detect 92.3 percent of colorectal cancer in average risk patients.
The FDA is not obligated to follow the advisory committee's recommendation, but will consider its guidance as Cologuard is evaluated.
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In a 90-site trial of the test, Cologuard was found to detect 92.3 percent of colorectal cancer in average risk patients.
The FDA is not obligated to follow the advisory committee's recommendation, but will consider its guidance as Cologuard is evaluated.
More Articles on Gastroenterology:
11 Statistics on Liver Disease & Pancreatitis in the U.S.
18 Statistics on Gastroenterologist Compensation in 2012 vs. 2011
Advocacy in the GI Field: Q&A With AGA President Dr. Anil Rustgi