Clinical Trials

Inclusion Criteria:

• Subject is male or female, ≥ 40 years of age at the time of enrollment. 
• Subject presents for a screening colonoscopy per standard of care. 
• Subject has no symptoms or signs that require immediate, or near term, referral for diagnostic or therapeutic colonoscopy. 
• Subject understands the study procedures and can provide informed consent to participate in the study and authorization for release of relevant protected health information (PHI) to the Study Investigator.

Exclusion Criteria: 

• Subject has a personal history of CRC or advanced precancerous lesions.
• Subject has a diagnosis or medical / family 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, or Familial Hyperplastic Polyposis.
• Subject has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis and/or Crohn’s disease.
• Subject has a diagnosis of Cronkhite-Canada Syndrome.
• Subject has had a positive Cologuard within the previous 2 years, or fecal occult blood test or FIT within the previous 6 months.
• Subject has undergone a colonoscopy within the previous 9 years, with the exception of a failed colonoscopy due to poor bowel preparation. Failed colonoscopy must have been within the past year and without therapeutic intervention.
• Subject has had overt rectal bleeding within the previous 30 days.
• Subject has any condition that in the opinion of the Investigator should preclude participation in the study.