Cologuard Plus: 95.3% cancer sensitivity and 43.3% advanced-precancer sensitivity; less than half detected in one screening round.

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The Other Number

There’s another number.

FDA labeling for Cologuard Plus reports 95.3% sensitivity for cancer and 43.3% for advanced precancer in one screening round.

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The evidence behind it

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FDA Cologuard Plus labeling reports 95.3% colorectal-cancer sensitivity (81 of 85 people with cancer) and 43.3% advanced-precancer sensitivity (849 of 1,962 people with advanced precancer), in one screening round. These figures use the FDA primary-effectiveness population, not the published BLUE-C analysis set.

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.