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Development of an effective, noninvasive colorectal cancer screening test has long been a priority. Although fecal DNA testing has shown potential in preliminary studies, the current report is the first large scale screening study among average-risk, asymptomatic individuals. The study was conducted at 81 U.S. sites and was sponsored by the developer of the fecal DNA test used in the study.
A total of 4404 subjects provided fecal samples for DNA analysis, completed nonrehydrated Hemoccult II cards for fecal occult blood testing (FOBT), and underwent colonoscopy. Fecal DNA analysis was performed on a subgroup of 2507 subjects, including all subjects with adenocarcinoma or advanced adenoma, plus randomly chosen subjects with no polyps, tubular…