Exact CRC Screening Test: Stool Sample Collection Study to Support Assay Validation Testing

Exclusion Criteria

• •Subject has any condition which, in the opinion of the investigator should preclude participation in the study.
• •Subject had any findings on recent or any previous colonoscopy including benign, and/or hyperplastic polyps of any size. (Note: Tissue biopsies that result in no histopathology findings are acceptable.)
• •Subject has a history or recent diagnosis of CRC or adenoma.
• •Subject has a history of aerodigestive tract cancer.
• •Subject has had a positive fecal occult blood test or FIT within the previous six (6) months.
• •Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease.
• •Subject has had 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.
• •* Greater than or equal to (\>=)2 first-degree relatives who have been diagnosed with colon cancer. (Note: first-degree relatives include parents, siblings and offspring).
• •* One first-degree relative with CRC diagnosed before the age of 60.
• •* 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.