Evaluation of the ctDNA LUNAR Test in an Average Patient Screening Episode

Prior treatment

• Positive FIT/FOBT result within the previous 6 months
• Has completed Cologuard or Epi proColon testing within the previous 3 years
• History of any malignancy (patients who have undergone surgical removal of skin squamous cell cancer may be enrolled provided the procedure was completed at least 12 months prior to the date of provision of informed consent for the study)
• Currently taking any anti-neoplastic or disease-modifying anti-rheumatic drugs (DMARDs)
• Any major physical trauma (e.g. disruption of tissue, surgery, organ transplant, blood product transfusion) within the 30 days leading up to the provision of informed consent
• Participation in a clinical research study in which an experimental medication has been administered or may be administered within the 30 days leading up to providing informed consent or may be administered through the time of colonoscopy

Other illness

• History of colorectal cancer
• Known diagnosis of inflammatory bowel disease
• Known hereditary/germline risk of colorectal cancer (for example, Lynch syndrome or Hereditary Non-Polyposis CRC \[HNPCC\], or Familial Adenomatous Polyposis \[FAP\])
• Known medical condition which, in the opinion of the investigator, should preclude enrollment into the study

Age

• Positive family history of colorectal cancer, defined as having one or more first- degree relatives (parent, sibling, or child) with CRC at any age

Other

• Undergoing colonoscopy for investigation of symptoms
• Has undergone colonoscopy within preceding 9 years

• Subjects aged 45-84 years at time of consent
• Intended to undergo screening colonoscopy
• Considered by a physician or healthcare provider as being of 'average risk' for CRC
• Willing to consent to blood draw pre-bowel preparation administration prior to undergoing colonoscopy within 60 days of the date of the investigational blood draw
• Willing to consent to follow-up for two years as per protocol