Pilot Study for Colorectal Cancer and Advanced Adenoma Detection With the Mainz Biomed Colorectal Cancer Test

Inclusion Criteria19

• 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 family history of colorectal cancer (defined as one or more first degree relatives including parent, sibling, or child)
• 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 any sex and ≥ 18 years of age
• Subject is able and willing to give informed consent
• Through imaging, a positive non-invasive screening test, or colonoscopy requiring additional intervention subject is suspected or known to have Colorectal Cancer or Advanced Adenoma
• Subject has not yet been treated (e.g., ablation, surgical resection, radiation, chemotherapy, etc.) and still has at least one intact or partially intact lesion
• Subject must have a diagnostic colonoscopy or surgical intervention scheduled within 90 days of sample collection
• 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