Colorectal Cancer and Pre-Cancerous Adenoma Non-Invasive Detection Test Study

Inclusion Criteria: * Subject is male or female, ≥45 years of age * Subject is able to understand the study procedures, and is able to provide consent to participate in the study and authorizes release of relevant protected health information through reviewing and consenting to a HIPAA medical release form * Subject is able and willing to provide stool samples within the 120 days prior to a colonoscopy procedure * Subject is able and willing to undergo a colonoscopy after providing a stool sample Exclusion Criteria: * Subject had any precancerous finding on most recent colonoscopy. This does not include benign, and/or hyperplastic polyps of any size (Note: Tissue biopsies that result in no histopathology findings are acceptable) * Subject has a history or diagnosis of colorectal cancer * Subject has a history of aerodigestive tract cancer * Subject has had a positive non-invasive screening diagnostic within the associated recommended intervals: * Fecal occult blood test or fecal immunochemical test within the previous twelve (12) months * FIT-DNA test within the previous 36 months * Subject has had a colonoscopy in the previous nine (9) years * Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease * Indication for colonoscopy was due to overt rectal bleeding, e.g., hematochezia or melena, within the previous 30 days. (Blood on toilet paper, after wiping, does not constitute rectal bleeding) * Subject has a diagnosis or per…