A Study of Cologuard™ in an Average Risk Population Assessing a Three Year Test Interval

This is a prospective longitudinal study to assess the impact of repeat Cologuard testing at
3 years in average risk patients. Enrolled subjects will be prescribed Cologuard per approved
labeling at baseline. Subjects with positive results will be referred to colonoscopy and
study participation completed. Subjects with negative Cologuard results will be seen annually
for 3 years. At year 3, subjects will repeat Cologuard, followed by colonoscopy, regardless
of the Cologuard test outcome. Subjects who have a colonoscopy at any time during the study
will be discontinued following collection of the colonoscopy and associated histopathology
results.

Inclusion Criteria:

1. Subject has been prescribed Cologuard for colorectal cancer screening

2. Subject is at average risk for development of colorectal cancer

3. Subject is 50 years or older

4. Subject willing and able to sign informed consent.

Exclusion Criteria:

1. Subject had a colonoscopy in the previous 9 years

2. Subject has undergone any double-contrast barium enema, virtual (CT-based)
colonoscopy, or flexible sigmoidoscopy within the previous five (5) years.

3. Subject has had a positive fecal occult blood test or FIT within the previous six (6)
months.

4. Subject has any condition that in the opinion of the investigator should preclude
participation in the study (e.g., subject not eligible for a diagnostic colonoscopy).

5. Subject has a history of colorectal cancer or advanced adenoma.

6. Subject has a history of aerodigestive tract cancer

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.

10. Subject has a family history of:

- Familial adenomatous polyposis (also referred to as "FAP", including attenuated
FAP).

- Hereditary non-polyposis colorectal cancer 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), Gardner's Syndrome, Turcot's (or
Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Cronkhite-Canada
Syndrome, Neurofibromatosis and Familial Hyperplastic Polyposis.