Cologuard showed superior sensitivity compared with FIT* in detecting colorectal cancer (CRC) and advanced precancerous polyps1,2

In a prospective, head-to-head, point-in-time, 90-site, pivotal study of 10,000 patients aged 50-84 years at average risk for CRC, published in The New England Journal of Medicine, Cologuard demonstrated1†:

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FIT failed to detect 3 times more
total CRC findings (stages I to IV)1

87% specificity overall with Cologuard§ vs 95% with FIT1

False positives and false negatives did occur in this pivotal study. 13% of patients without colorectal cancer or advanced adenomas received a positive result (false positive), and 8% of patients with cancer received a negative result (false negative). The clinical validation study was conducted in patients 50 years of age and older.

Cologuard is based on breakthrough, noninvasive stool DNA (sDNA) technology1,2

The proprietary sDNA technology of Cologuard can analyze and detect 11 distinct biomarkers that are used to identify CRC and precancerous polyps.1,2



Cologuard uses advanced multi-target, sDNA technology to analyze 11 distinct biomarkers—10 more than FIT1-3*

  • NDRG4
  • BMP3
  • 7 KRAS point mutations
  • ACTB

Unlike Cologuard, FIT only detects hemoglobin in stool, increasing the chance that FIT can deliver a false negative result due to intermittent bleeding.1,3

Cologuard is not for high-risk individuals, including patients with a personal history of colorectal cancer and adenomas; who have had a positive result from another colorectal cancer screening method within the last 6 months; have been diagnosed with a condition associated with high risk for colorectal cancer such as IBD, chronic ulcerative colitis, Crohn's disease; or who have a family history of colorectal cancer, or certain hereditary syndromes.