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

• Average risk persons eligible for CRC screening that have received a positive FIT outcome in the past 6 months and are scheduled for a screening colonoscopy at one of the participating centers will be offered to participate in the study.
• Following the informed consent process, subjects will undergo the Gixam test.

• A subset of 50 subjects will participate in the repeatability assessment. They will undergo three (3) repetitive Gixam tests one after the other, by the same operator.
• Both the subject and the endoscopist will be blinded to the Gixam outcome
• All subjects will thereafter undergo a standard of care HD-WL colonoscopy procedure.
• All resected and retrieved lesions will be sent separately for histopathological evaluation.

Inclusion criteria

• Subjects aged ≥50 - ≤80 years.
• Able to provide a signed informed consent.
• Underwent FIT screening within the past 6 months with a positive result.
• Scheduled for a FIT positive screening colonoscopy at investigational site.

Exclusion criteria

• 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.
• Personal history of CRC.
• Family history of CRC, defined as having one or more first-degree relatives (parent, sibling, or child) with CRC at any age.
• 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, and/or IBD-undefined.
• Subjects with the disability to extend their tongue.
• Subjects with tongue piercing.
• Dental visit in the 7 days prior to the Gixam test.
• Intake of pro-biotics over the past 3 months pre-Gixam test.
• Subject has any condition that in the opinion of the Investigator should preclude participation in the study.