Sponsor Decision

The primary endpoint is to obtain longitudinal information on four sub-populations from the Cologuard Post-Approval Study.

Subjects who consented to enroll in Exact Sciences Protocol 2014-01, that fit one of the following sub-populations, will be asked to participate in the sub-study. Population 1 includes those whose Cologuard T0 result was positive and colonoscopy result was negative. Population 2 includes those whose Cologuard T0 result was positive and subject declined to complete a colonoscopy per protocol. Population 3 includes those whose Cologuard result at T3 was positive and colonoscopy result at T3 was negative. Population 4 includes those whose Cologuard result at T3 was positive and subject declined to complete a colonoscopy per protocol. Subjects that enrolled in the Exact Sciences Protocol 2014-01, who provided written informed consent to participate in this sub-study, will asked to complete the Follow-Up Questionnaire during a phone interview.

Inclusion Criteria:

• Subject falls into one of the 4 sub-populations
• Willing to provide informed consent

Exclusion Criteria:

• Death
• Investigator/sponsor decision
• Subject withdrew consent

There are four sub-populations of the Cologuard Post-Approval Study (2014-01) under observation: positive first Cologuard test and negative colonoscopy or no colonoscopy and positive 3-year follow-up Cologuard test and negative colonoscopy or no colonoscopy.