Cologuard Contraindications
Cologuard is contraindicated in high-risk individuals including those with a personal history of colorectal cancer or advanced adenomas, family history of colorectal cancer in a first-degree relative diagnosed before age 60, personal history of inflammatory bowel disease, and known or suspected hereditary colorectal cancer syndromes such as Lynch syndrome or familial adenomatous polyposis. 1
Absolute Contraindications
High-Risk Personal History
- Personal history of colorectal cancer or advanced adenomas - these patients require surveillance colonoscopy, not screening with stool-based tests 1
- Personal history of inflammatory bowel disease (Crohn's disease or ulcerative colitis) - requires specialized surveillance colonoscopy with dysplasia assessment 2, 1
High-Risk Family History
- Family history of colorectal cancer in a first-degree relative diagnosed before age 60 1
- Multiple affected first-degree relatives with colorectal cancer - these individuals should undergo genetic screening and colonoscopy 2, 1
Hereditary Cancer Syndromes
- Known or suspected Lynch syndrome 1
- Familial adenomatous polyposis 1
- Other hereditary colorectal cancer syndromes - these patients require regular colonoscopy starting at younger ages 2, 1
Age Restrictions
- Approved only for average-risk adults aged 45-85 years 2
- Not appropriate for individuals under age 45 unless they meet high-risk criteria requiring colonoscopy 2
Clinical Context Contraindications
Active Gastrointestinal Symptoms
- Clinically evident intestinal obstruction - bowel preparation may exacerbate obstruction or cause perforation 2
- Symptomatic patients with signs of gastrointestinal pathology should undergo diagnostic evaluation with colonoscopy rather than screening 2
Recent Colonoscopy
- While not an absolute contraindication, Cologuard is intended for primary screening, not for surveillance after recent colonoscopy in most guidelines 2
- However, emerging data suggests it may have utility in patients with prior normal colonoscopy who decline repeat colonoscopy, though this remains outside standard recommendations 3
Important Clinical Caveats
The test is designed exclusively for average-risk screening populations. 2 Any deviation from average-risk status (personal history, family history, hereditary syndromes, or inflammatory bowel disease) mandates colonoscopy as the appropriate screening/surveillance modality rather than stool-based testing. 2, 1
Patients with life expectancy less than 10 years should generally not undergo colorectal cancer screening of any type, as the benefits are unlikely to outweigh risks. 1
The distinction between screening and surveillance is critical - Cologuard is a screening test for average-risk individuals, not a surveillance tool for high-risk populations. 2, 1 High-risk individuals require the direct visualization, biopsy capability, and therapeutic intervention that only colonoscopy provides. 4