Stool Sample Collection Protocol for Development of Screening Test for Colorectal Cancer and Other Digestive Tract Cancers

This is a multi-site, prospective sample collection study. Subjects will be men and women,
40-90 years of age, inclusive, each with a colonoscopic biopsy-based diagnosis of CRC and/or
a pre-malignant colorectal lesion with large enough residual lesion to require subsequent
surgical excision or complex colonoscopic polypectomy.

One stool sample from approximately 300 subjects will be collected in this study. A blood
sample will also be collected from subjects.

Inclusion Criteria:

- Subject is male or female, 40-90 years of age, inclusive.

- Subject has a diagnosis of CRC, at any stage, confirmed with a tissue biopsy or
colorectal polyp/adenoma/mass that is equal or larger than 1 cm in pre-enrollment
colonoscopy with residual lesion in the colon of sufficient size to require additional
surgical excision or complex colonoscopic polypectomy.

- Subject understands the study procedures and is able to provided informed consent to
participate in the study and authorization for release of relevant protected health
information to the study Investigator.

Exclusion Criteria:

- Subject has actively bleeding hemorrhoids (blood on toilet paper or bright red blood
clots in the toilet bowel during bowel movement).

- Individual has a condition the Investigator believes would interfere with his or her
ability to provide informed consent, comply with the study protocol, which might
confound the interpretation of the study results or put the person at undue risk.