THE OTHER NUMBER — COLOGUARD PLUS

In the FDA labeling's BLUE-C primary effectiveness population (18,911 participants), Cologuard Plus detected 81 of 85 participants with colorectal cancer (95.3%) and 849 of 1,962 with advanced precancerous lesions (43.3%).

These are single-round sensitivity estimates in two different disease groups. Advanced precancerous lesions are higher-risk growths defined in the study, not all polyps. The numbers do not estimate an individual's risk after a negative result or prove a difference in lifetime outcomes.

Colonoscopy can find and remove precancerous polyps during the same examination. It can also miss lesions and has risks, including bleeding, perforation, and sedation-related complications. Stool screening followed by appropriate colonoscopy can contribute to prevention. Discuss the right screening plan with your clinician.

BLUE-C was funded by Exact Sciences, manufacturer of Cologuard Plus.

Source: FDA Cologuard Plus Instructions for Use, Rev. 3, December 2024, Table 16-15, printed page 47.
https://www.accessdata.fda.gov/cdrh_docs/pdf23/P230043C.pdf#page=47

NCI screening and polyp-removal information:
https://www.cancer.gov/types/colorectal/screening-fact-sheet

The NEJM publication reports 93.9% and 43.4% in a broader analysis population. This poster consistently uses the FDA primary effectiveness figures.

Colonoscopy First is an independent education campaign, not an endorsement by a medical organization. Source check: September 26, 2026.