Exact CRC Screening Test: Stool Sample Collection Study to Support Assay Validation Testing

Inclusion Criteria:

- Subject is male or female, 50-84 years of age, inclusive.

- Subject is at average risk for development of CRC and has undergone a screening
colonoscopy with a normal result at least 30 days and no more than 120 days before
providing a stool sample for the study. For the purposes of this study, a "normal"
colonoscopy result is defined as no polyps of any size detected or removed (including
benign, hyperplastic polyps).

- Subject is able to understand the study procedures, and is able to provide signed
consent to participate in the study and authorizes release of relevant protected
health information through signing a HIPAA consent.

- Subject is able and willing to provide stool samples at least 30 days and no more
than 120 days after undergoing a colonoscopy that resulted in normal findings,
according to the written instructions provided to them.

Exclusion Criteria:

- Subject has any condition which, in the opinion of the investigator should preclude
participation in the study.

- Subject had any findings on recent or any previous colonoscopy including benign,
and/or hyperplastic polyps of any size. (Note: Tissue biopsies that result in no
histopathology findings are acceptable.)

- Subject has a history or recent diagnosis of CRC or adenoma.

- Subject has a history of aerodigestive tract cancer.

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

- Subject has had a prior colorectal resection for any reason other than sigmoid
diverticular disease.

- 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)

- 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.

- Greater than or equal to (>=)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.