Clinical Trials

Inclusion Criteria:

• Subject is at average risk for development of CRC. 
• Subject is able and willing to undergo a screening colonoscopy. 
• Subject is ≥ 45 and ≤ 49 years of age at the time of enrollment. 
• Subject is willing and able to sign informed consent.
• Subject is able and willing to provide stool sample(s) according to written instructions provided.

Exclusion Criteria: 

• Subject has a history of CRC or adenoma. 
• Subject has ≥2 first-degree relatives who have been diagnosed with CRC. 
• Subject has one first-degree relative with CRC diagnosed before the age of 60. 
• Subject has any of the following:
  • Overt rectal bleeding, e.g., hematochezia or melena within the previous 30 days (blood on toilet paper, after wiping, does not constitute rectal bleeding).
  • Positive fecal occult blood test or FIT within the previous six (6) months.
  • Subject has had a previous colonoscopy.
  • Subject has undergone any double-contrast barium enema, virtual (CT-based) colonoscopy, or flexible sigmoidoscopy within the previous five (5) years. 
• Subject has a diagnosis or personal history of any of the following conditions, including: Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome). Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome"). Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis and Familial Hyperplastic Polyposis. 
• Subject has a family history of: Familial adenomatous polyposis (also referred to as "FAP"), Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome"). 
• Subjects with Cronkhite-Canada Syndrome. 
• Subject has a diagnosis of inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease. 
• Subject has a history of aerodigestive tract cancer. 
• Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease. 
• Subject has any condition that in the opinion of the investigator should preclude participation in the study.