Focus of the Report: This report examines the analytical validity, clinical validity, and clinical utility of the Cologuard stool DNA test for the qualitative detection of colorectal neoplasia–associated DNA markers and for the presence of occult hemoglobin in human stool, which may indicate the presence of colorectal cancer (CRC) or advanced adenoma (AA), in adults 45 years of age and older who are at average risk for CRC. Cologuard is a non-invasive screening option, not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.

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