Collection of Samples USOPTIVAL Study

Inclusion Criteria:

Arm A:

1. Must be 45-84 years of age.

2. Must have a suspected advanced adenoma or be newly diagnosed with CRC, still notresected, and scheduled for surgery.

3. Able to comprehend, sign, and date the written informed consent document.

Arm B:

1. Must be 45-84 years of age.

2. Able and willing to undergo a standard-of-care screening colonoscopy within 60 days.

3. Able to comprehend, sign, and date the written informed consent document.

Exclusion Criteria:

Arm A Only:

1. Subject with curative biopsy during colonoscopy.

Arm B Only:

1. Subjects with positive FIT Test results in the 6 months preceding enrollment.

2. Subject has a current diagnosis of cancer.

Arms A & B:

1. Subject has a personal history of aerodigestive or digestive tract cancers.

2. Subjects having undergone previous partial surgical removal of one or more portionsof their colon due to a reason other than colorectal cancer.

3. Has a known diagnosis or personal history of any of the following high-riskindications for colorectal cancer:

4. Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) andCrohn's disease.

5. Familial adenomatous polyposis ("FAP", including attenuated FAP).

6. Hereditary non-polyposis colorectal cancer syndrome ("HNPCC" or "LynchSyndrome").

7. Serrated polyposis syndrome

8. 2 first-degree relatives (e.g., parents, siblings, and offspring) who have beendiagnosed with colon cancer.

9. One first-degree relative with CRC diagnosed before the age of 60.

10. A significant disease which, in the Investigator's opinion, would exclude thesubject from the study.

11. Legal incapacity or limited mental capacity.

12. Medical or psychological conditions that would not permit the subject to completethe study or sign informed consent.

13. The patient has a known or documented previous or current medical history ofinfectious diseases that can be transmitted through blood (E.g. Hepatitis, HIV,etc.), including patients that have been treated, are currently being treated, orhave not been treated for that conditions.

14. The patient is known to be pregnant when recruited or during her participation inthe study.