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

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 personal history of any of the following high-risk conditions for colorectal cancer:
• •* Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease
• •* Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP)
• •* Hereditary non-polyposis colorectal cancer syndrome (also referred to as "HNPCC" of "Lynch Syndrome")
• •* Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Gardner's Syndrome, Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Cronkhite-Canada Syndrome, Neurofibromatosis and Familial Hyperplastic Polyposis