Cologuard Patient Information Leaflet (PIL)

Approximate Reading Time: 8-10 minutes

🔬 Clinical Applications

Cologuard is a prescription-only, non-invasive stool DNA screening test designed for colorectal cancer detection.

• Primary Use: Screening for colorectal cancer and advanced precancerous lesions
• Target Population: Adults 45 years of age and older at average risk for colorectal cancer
• Detection Method: Identifies specific DNA markers and occult (hidden) blood in stool samples
• Test Type: Single stool specimen collection with laboratory analysis
• Result Types:
  • Positive: Detected possible signs of precancer or colorectal cancer
  • Negative: Did not detect signs of precancer or colorectal cancer

Official Resources:

• Main Website: https://www.cologuard.com
• FDA Documentation: https://www.accessdata.fda.gov/cdrh_docs/pdf13/P130017c.pdf
• Patient Brochure: https://www.cologuard.com/-/media/project/exactsciences/websites/cologuard-pattern-library/files/resources-and-support/cologuard-patient-brochure.pdf

🏥 Western Therapeutic Actions

Note: Cologuard is a diagnostic screening test, not a therapeutic treatment. 

What Cologuard Detects:

• DNA biomarkers associated with colorectal cancer
• DNA biomarkers associated with advanced precancerous lesions
• Occult (hidden) blood in stool samples

Clinical Performance (Based on Large Clinical Studies):

• Correctly detected 95% of colon cancers
• Detected 43% of advanced precancerous lesions
• More effective than ordinary fecal blood tests (FIT) for finding both precancer and cancer

Lab Values to Discuss With Dr. Skip:

• Previous colorectal cancer screening history
• Family history of colorectal cancer or polyps
• Any symptoms of gastrointestinal bleeding
• Personal history of inflammatory bowel disease

💊 Administration

Note: As a one-time screening test – below are collection instructions.

Collection Process:

• One stool specimen collected per test
• Use provided collection kit with preservative solution (Tris-buffered EDTA solution)
• Add preservative to stool sample in sealed container
• Return sealed container to laboratory promptly
• No repeat dosing required unless follow-up screening is indicated by guidelines

Testing Frequency:

• Follow healthcare provider recommendations
• Generally repeated every 3 years if negative (per screening guidelines)
• Immediate follow-up required if positive result

⚠️ Cautions & Contradictions

DO NOT Collect Sample If You Have:

• Active rectal bleeding
• Bleeding hemorrhoids
• Cuts or wounds on your hands
• Menstrual period
• Diarrhea or abnormal stool consistency
• Personal history of colorectal cancer
• Personal history of advanced precancerous lesions

Important Considerations:

• Prescription required from healthcare provider
• Not suitable for individuals at increased risk (family history, genetic conditions)
• Positive result requires diagnostic colonoscopy follow-up
• Negative result does not eliminate need for future screening

Legal Disclaimer:

⚖️ IMPORTANT LEGAL NOTICE: Never self-prescribe or self-order Cologuard without consultation with a qualified healthcare provider. This test requires a prescription and professional medical interpretation. Improper use may lead to missed diagnoses, unnecessary anxiety, or delayed treatment. Always consult with your physician before initiating any screening protocol. This information is for educational purposes only and does not constitute medical advice.

🥗 Nutritional Guidance

Note: No specific dietary restrictions are required before Cologuard collection.

General Recommendations:

• Maintain normal diet before and during collection
• Stay hydrated for optimal digestive health
• High-fiber diet supports regular bowel movements
• Limit processed foods that may affect gut health
• Discuss any supplements with your healthcare provider

Post-Screening Nutrition:

• If positive result: Follow gastroenterologist dietary recommendations
• If negative result: Continue healthy eating patterns
• Consider Mediterranean-style diet for colon health
• Reduce red meat and processed meat consumption

📞 Questions? Contact your healthcare provider or Exact Sciences at 1-844-870-8878