A Stool DNA-based SDC2 Methylation Test for the Early Detection of Colorectal Cancer

Inclusion Criteria:

Subjects enrolled into the study must meet the following criteria:

• Individuals who agree to voluntarily sign an informed consent prior to theinitiation of screening

• Adults aged ≥ 40 years

• Subjects who are at high-risk (Asia Pacific Colorectal Screening (APCS) Score: 4.0~7.0) of developing CRC

• Subjects who are able and willing to undergo colonoscopy screening within 12 monthsof consent among individuals who reserved a visit in the division ofgastroenterology or health check-up.

Exclusion Criteria:

Subjects will be excluded from enrolling into the study if any of the following criteria are met:

• Individuals who do not agree to voluntarily sign an informed consent prior to theinitiation of screening

• Adults aged < 40 years

• Subjects who are not at high-risk (APCS Score ≤ 3.0) of developing CRC

• Subjects who will not undergo colonoscopy screening within 12 months of consent

• Subjects who have had a positive FIT or fecal occult blood test within the previous 2 weeks

• Colorectal cancer patients who did not underwent curative treatment

• Subjects who have had a prior history of colorectal resection

• Subjects who have had overt rectal bleeding or melena within the previous 2 weeks

• Subjects who have a family history or a prior history of hereditary CRC orcolorectal neoplasm: Lynch syndrome (HNPCC), familial adenomatous polyposis,MUTYH-associated polyposis, Juvenile polyposis syndrome, Peutz-Jeghers syndrome, andserrated polyposis syndrome, etc.

• Subjects who have inflammatory bowel diseases including Crohn's disease, ulcerativecolitis or Behcet disease

• Subjects who participated in any "interventional" clinical study within the previous 30 days

• Subject has any condition which, in the opinion of the medical staff should precludeparticipation in the study