Clinical Validation of An Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, for Colorectal Cancer Screening "BLUE-C"

Inclusion Criteria: Subjects must meet the following criteria to be eligible for the study:

1. Subject is ≥ 40 years of age at the time of enrollment.
2. Subject presents for a screening colonoscopy per standard of care.
3. Subject has no symptoms or signs that require immediate, or near term, referral fordiagnostic or therapeutic colonoscopy.
4. Subject is able and willing to sign informed consent

Exclusion Criteria:

1. Subject has a history of CRC or advanced precancerous lesions.
2. Subject has a diagnosis or medical / family history of any of the followingconditions, including:

• Familial adenomatous polyposis (also referred to as "FAP", including attenuatedFAP and Gardner's syndrome),
• Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "LynchSyndrome"),
• Other hereditary cancer syndromes including but are not limited to Peutz-JeghersSyndrome, MYH-Associated Polyposis (MAP), Turcot's (or Crail's) Syndrome,Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis, or FamilialHyperplastic Polyposis.

3. Subject has a diagnosis or personal history of inflammatory bowel disease (IBD)including chronic ulcerative colitis and/or Crohn's disease.
4. Subject has a diagnosis of Cronkhite-Canada Syndrome.
5. Subject has had a positive Cologuard within the previous 2 years, or fecal occultblood test or FIT within the previous 6 months.
6. Subject has undergone a colonoscopy within the previous 9 years with the exception ofa failed colonoscopy due to poor bowel preparation. Failed colonoscopy must have beenwithin the past year and without therapeutic intervention.
7. Subject has had overt rectal bleeding within the previous 30 days.
8. Subject has any condition that in the opinion of the Investigator should precludeparticipation in the study.