How effective is Cologuard?

In a 10,000-patient clinical study, Cologuard found 92% of colon cancers.It also found 69% of high-risk precancers (high-grade dysplasia), those most likely to develop into cancer.

Both false positives and false negatives do occur. In a clinical study of Cologuard, 13% of people without cancer or precancer tested positive. Any positive should be followed by a diagnostic colonoscopy. Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient. Cologuard performance when used for repeat testing has not been evaluated or established.

  1. Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014;370(14):1987-97.
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