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

This study is to determine how the Mainz Biomed Colorectal Cancer Screening Test works when used in people aged ≥45 years of age and at an average risk of developing colorectal cancer.

Inclusion Criteria:Subject is any sex and ≥45 years of ageSubject must be advised to have or be scheduled for a screening colonoscopySubject 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 diseaseno 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 diseaseFamilial 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 PolyposisCronkhite Canada SyndromeSubject 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 formSubject is able and willing to provide stool samples within ninety (90) days before the colonoscopy procedureSubject is able and willing to undergo a colonoscopy after providing a stool sampleExclusion Criteria:Subject had any precancerous findings on most recent colonoscopy.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 appendicealSubject has had a positive non-invasive screening diagnostic within the associated recommended intervalsHigh-sensitivity fecal occult blood test or fecal immunochemical test within the previous twelve (12) monthssDNA-FIT test within the previous thirty-six (36) monthsSubject has had a colonoscopy in the previous nine (9) yearsSubject has had a prior colorectal resection for any reason other than sigmoid diverticular diseaseIndication for colonoscopy due to overt rectal bleeding (e.g., hematochezia or melena) within the previous thirty (30) daysSubject has any condition that in the opinion of the investigator should preclude participation in the study