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

Inclusion Criteria:

1. Subject is average risk for development of colorectal cancer (as defined by theinclusion and exclusion criteria below).

2. Subject is able and willing to undergo a screening colonoscopy within 90 days ofenrollment.

3. Subject is 50 to 84 years of age inclusive.

4. Subject is able to comprehend, sign, and date the written informed consent document toparticipate in the study.

5. Subject is able and willing to provide stool samples according to written instructionsprovided to them.

Exclusion Criteria:

1. Subject has any condition which, in the opinion of the investigator should precludeparticipation 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 sigmoiddiverticular disease.

8. Subject has had overt rectal bleeding, e.g., hematochezia or melena, within theprevious 30 days. (Blood on toilet paper, after wiping, does not constitute rectalbleeding).

9. Subject has a diagnosis or personal history of any of the following high-riskconditions for colorectal cancer:

• Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) andCrohn'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 attenuatedFAP).

• 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-JeghersSyndrome, MYH-Associated Polyposis (MAP), Gardner's Syndrome, Turcot's (orCrail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Cronkhite-CanadaSyndrome, 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 inwhich an experimental treatment is administered or might be administered through arandomized assignment of the subject to one or more study groups.