Evaluation of Gixam's Efficacy Predicting Pre-cancerous Colorectal Polyps and Colorectal Cancer

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.