Clinical Performance of the Mainz Biomed Colorectal Cancer Screening Test for Colorectal Cancer and Advanced Adenoma

Prior treatment

• Subject has had a positive non-invasive screening diagnostic within the associated recommended intervals
  • High-sensitivity fecal occult blood test or fecal immunochemical test within the previous twelve (12) months
  • sDNA-FIT test within the previous thirty-six (36) months
• Subject has had a colonoscopy in the previous nine (9) years
• Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease
• Indication for colonoscopy due to overt rectal bleeding (e.g., hematochezia or melena) within the previous thirty (30) days

Other illness

• Subject has a history of abnormal imaging suggesting colorectal cancer (e.g., colonography, MRI, CT, barium enema)
• Subject has a history of any of the following cancers: oral, head and neck, lung, esophagus, gastric, biliary/liver, pancreatic, small bowel, or appendiceal
• Subject has any condition that in the opinion of the investigator should preclude participation in the study

Other

• Subject had any precancerous findings on most recent colonoscopy.

• Subject is any sex and ≥45 years of age
• Subject must be advised to have or be scheduled for a screening colonoscopy
• Subject is at average risk for colorectal cancer according to the United States Preventive Services Task Force (USPSTF) guidelines, including:
  • no prior diagnosis of colorectal cancer, adenomatous polyps, or inflammatory bowel disease
  • no personal diagnosis or family history of known genetic disorders that predispose them to a high lifetime risk of colorectal cancer including:
  • Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease
  • Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP)
  • Hereditary non-polyposis colorectal cancer syndrome (also referred to as "HNPCC" or "Lynch Syndrome")
  • Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Gardner's Syndrome, Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis and Familial Hyperplastic Polyposis
  • Cronkhite Canada Syndrome
• Subject can understand the study procedures and is able to provide consent to participate in the study and authorizes release of relevant protected health information through reviewing and consenting to a Health Insurance Portability and Accountability Act (HIPAA) medical release form
• Subject is able and willing to provide stool samples within ninety (90) days before the colonoscopy procedure
• Subject is able and willing to undergo a colonoscopy after providing a stool sample