Clinical Research Directory

Inclusion Criteria: 1. Subjects aged ≥50 - ≤80 years. 2. Able to provide a signed informed consent. 3. Underwent FIT screening within the past 6 months with a positive result. 4. Scheduled for a FIT positive screening colonoscopy at investigational site. Exclusion Criteria: 1. Has undergone colonoscopy within the past nine (9) years, except for a failed colonoscopy due to poor bowel preparation, which must have been performed within the past year without therapeutic intervention. 2. Personal history of CRC. 3. Family history of CRC, defined as having one or more first-degree relatives (parent, sibling, or child) with CRC at any age. 4. 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. 5. Subject has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis, and/or Crohn's disease, and/or IBD-undefined. 6. Subjects with the disability to extend their tongue. 7. Subjects with tongue piercing. 8. Dental visit in the 7 days prior to the Gixam test. 9. Intake of pro-biotics over the past 3 months pre-Gixam test. 10. Subject has any condition that in the opinion of the Investigator should preclude participation in the study.