Protocol to Validate the Performance of the LifeKit® Prevent Colorectal Neoplasia Test for CRC Screening

Exclusion Criteria

• •An individual meeting any of the below criteria is ineligible.
• •1. Subject has a history of CRC or advanced precancerous lesions.
• •2. Subject has a diagnosis or medical history of any of the following conditions:
• •* 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
• •3. Subject has a diagnosis or personal history of inflammatory bowel disease (IBD), including chronic ulcerative colitis or Crohn's disease.
• •4. Subject has a diagnosis of Cronkhite-Canada Syndrome.
• •5. Subject has had a positive Cologuard, fecal occult blood test or FIT within the previous 2 years.
• •6. Subject has undergone a colonoscopy within the previous 9 years.
• •7. Subject has had overt rectal bleeding within the previous 30 days.
• •8. Subject has any condition that in the opinion of the Investigator should preclude participation in the study.