Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer

Exclusion Criteria

• •2. Subject is able and willing to undergo a screening colonoscopy within 90 days of enrollment.
• •3. Subject is 50 to 84 years of age inclusive.
• •4. Subject is able to comprehend, sign, and date the written informed consent document to participate in the study.
• •5. Subject is able and willing to provide stool samples according to written instructions provided to them.
• •1. Subject has any condition which, in the opinion of the investigator should preclude participation in the study.
• •2. Subject has undergone colonoscopy within the previous nine (9) years.
• •3. Subject has undergone any double-contrast barium enema, virtual (CT-based) colonoscopy, or flexible sigmoidoscopy within the previous five (5) years.
• •4. Subject has a history of colorectal cancer or adenoma.
• •5. Subject has a history of aerodigestive tract cancer.
• •6. Subject has had a positive fecal occult blood test or FIT within the previous six (6) months.
• •7. Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease.
• •8. Subject has had overt rectal bleeding, e.g., hematochezia or melena, within the previous 30 days. (Blood on toilet paper, after wiping, does not constitute rectal bleeding).
• •9. Subject has a diagnosis or personal history of any of the following high-risk conditions for colorectal cancer:
• •* Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease.
• •* \>= 2 first-degree relatives who have been diagnosed with colon cancer. (Note: first-degree relatives include parents, siblings and offspring).
• •* One first-degree relative with CRC diagnosed before the age of 60.
• •* Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP).
• •* Hereditary non-polyposis colorectal cancer syndrome (also referred to as "HNPCC" of "Lynch Syndrome").
• •* Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Gardner's Syndrome, Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Cronkhite-Canada Syndrome, Neurofibromatosis and Familial Hyperplastic Polyposis.
• •10. Subject has a family history of:
• •* Familial adenomatous polyposis (also referred to as "FAP").
• •* Hereditary non-polyposis colorectal cancer syndrome (also referred to as "HNPCC" or "Lynch Syndrome").
• •11. Participation in any "interventional" clinical study within the previous 30 days in which an experimental treatment is administered or might be administered through a randomized assignment of the subject to one or more study groups.