Head to Head Study Epi proColon and FIT

There is strong evidence supporting the use of FOBT in CRC screening, with the earliest
randomized controlled trials demonstrating a reduction in CRC incidence and mortality from
CRC screening. Despite the implementation and incremental improvements in gFOBT- and
FIT-based tests, they continue to represent a small percentage of CRC screening and
currently remain largely the province of large, integrated healthcare delivery systems.
Reasons for the limited adoption of stool-based testing are complicated, but include lack of
physician recommendation, patient preferences, and cultural barriers.

Availability of a blood-based test may overcome the adoption challenges presently facing
stool-based CRC screening and facilitate better compliance with CRC screening guidelines.
However, there are currently no FDA-approved in vitro diagnostic tests for detection of CRC
in a blood sample. As such, a high through-put blood-based test with performance
characteristics similar to fecal testing could satisfy this clinical need.

This study is designed to prospectively collect matched blood and stool specimens and
clinical data from screening guideline-eligible subjects found to have invasive colorectal
cancer (CRC) at colonoscopy, i.e. AJCC/UICC stages I, II, III, and IV, with collection of
specimens and testing after colonoscopy and from screening guideline-eligible subjects with
blood and stool specimens collected before colonoscopy. A completed subject will have a FIT
result, an Epi proColon result, and a medical diagnosis/colonoscopy determined clinical
status (CRC, non-CRC). Demographic and baseline covariates will be reported for each
individual.

Inclusion Criteria:

Group A

- Willing and able to sign an informed consent and adhere to study requirements

- 50 - 84 years of age at blood and stool sampling

- Colonoscopic diagnosis of colorectal carcinoma

- Colonoscopy within 6 months before inclusion into study

- Blood and stool sampling a minimum of 10 days after colonoscopy and before resection
surgery

Group B

- Willing and able to sign an informed consent and adhere to study requirements

- 50 - 84 years of age at blood and stool sampling

- Able to provide blood and stool sample prior to bowel prep and colonoscopy

Exclusion Criteria:

Group A

- Subject with curative biopsy during colonoscopy

Group A and B

- Previous personal history of CRC or previous colonocopy resulting in a recommendation
to repeat colonoscopy at an interval less than 10 years

- Neoadjuvant treatment

- Familial risk for colorectal cancer

- History of inflammatory bowel disease

- Acute or chronic gastritis

- Current diagnosis of any other cancer

- Overt rectal bleeding or bleeding hemorrhoids

- Known infection with HIV, HBV, or HCV

- Subject concurrently receiving intravenous fluid at the time of the sample collection