Prevention messagesPoster · 25 of 28
These Can Both Be True
A negative stool DNA result and advanced precancer can both be true.
Among 16,414 negative Cologuard Plus results in the FDA analysis, about 1 in 15 had advanced precancer found at colonoscopy. The report shown is an illustration, not an actual laboratory report.
The evidence behind it
The full caption
A negative stool DNA result can coexist with advanced precancer. The report shown is an illustrative example, not an actual laboratory report; the polyp image is labeled an AI-generated illustration.
Among 16,414 negative Cologuard Plus results in the FDA analysis, 1,113 people had advanced precancer found at colonoscopy: 6.8%, or about 1 in 15. This is not sensitivity. Separately, 1,113 of 1,962 people who had advanced precancer tested negative (56.7%). The study population averaged 63 years of age; individual risk varies. A negative result does not automatically mean immediate colonoscopy is needed.
BLUE-C was funded by Exact Sciences, maker of Cologuard Plus; multiple published-study authors were company employees. Single-round test performance does not establish lifetime screening outcomes.
Colonoscopy can find and remove detected precancerous polyps during the same exam. It can also miss lesions and has preparation, sedation, bleeding, perforation, and other burdens or risks. Stool-based screening remains a guideline-supported option; a positive stool test requires colonoscopy. Choose a screening plan you can complete with your clinician.