Mainz Biomed
The Mainz Biomed Colorectal Cancer Screening Test is being studied for its performance in the identification of the presence of colorectal cancer (CRC) or advanced adenoma (AA) in the colon in patients at average risk for colorectal cancer.
The primary objectives of this study are: 1. Feasibility and test optimization for the Mainz Biomed Colorectal Cancer Screening Test. 2. To develop the test algorithm and establish the clinical cut-off values for the Mainz Biomed Colorectal Cancer Screening Test. Each enrolled participant will be asked to provide a stool sample. The stool sample will be shipped to a laboratory and tested. No results will be provided to the site or the participant.
Group 1: Screening Group Inclusion Criteria 1. Subject is any sex and ≥45 years of age 2. Subject must be advised to have or be scheduled for a screening colonoscopy 3. 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…
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