Evaluation of Gixam's Efficacy Predicting the Presence of Advanced and Non-advanced Colorectal Neoplasia in a FIT Negative Population

Inclusion criteria

• Participants aged ≥45 - ≤84 years.
• Able to provide a signed informed consent.
• Considered by a physician or healthcare provider as being of 'average risk' for CRC.
• Scheduled for a screening colonoscopy at investigation site.

Exclusion criteria

• Undergoing colonoscopy for investigation of symptoms.
• Has undergone colonoscopy within preceding nine (9) years except for a failed colonoscopy due to poor bowel preparation. Failed colonoscopy must have been within the past year and without therapeutic intervention.
• Positive FIT or Fecal Occult Blood Test (FOBT) result within the preceding eleven (11) months.
• Has completed Cologuard, Sheild, ColoSense or Epi proColon testing within the preceding three (3) years.
• History of colorectal cancer.
• Family history of colorectal cancer, defined as having one or more first- degree relatives (parent, sibling, or child) with CRC at any age.
• Participant 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 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.
• Participant has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis and/or Crohn's disease.
• Participants with a disability to extend their tongue.
• Participants with tongue tremor.
• Participants with tongue piercing.
• Participants that had a dental visit in the 7 days prior to the Gixam test.
• Participants that have taken antibiotics or anti-fungal medications in the 14 days prior to the Gixam test.
• Participants that have taken anti-inflammatories or probiotics in the 14 days prior to the Gixam test.
• Participant is pregnant.
• Participant has any condition that in the opinion of the Investigator should preclude participation in the study.