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

87% specificity overall with Cologuard1‡ vs 95% with FIT1

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

Study design: Results from a prospective, head-to-head, point-in-time, 90-site, pivotal study of 10,000 patients aged 50 to 84 years at average risk for CRC, published in The New England Journal of Medicine. In the pivotal study, screening colonoscopy was the reference method.1 Cologuard performance in patients aged 45 to 49 years was estimated by subgroup analysis of near-age groups.§

The science behind Cologuard

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

Cologuard1,2

  • Detects 11 biomarkers
  • Detects altered DNA and hemoglobin
  • Detects biomarkers that are continuously shed into the stool
  • Consistent detection of both left- and right-sided cancers
VS

FIT1,3*

  • Detects 1 biomarker
  • Only detects hemoglobin in stool
  • Detects hemoglobin from polyps or lesions that bleed intermittently
  • Detection of proximal cancers is inferior to Cologuard

False positives and false negatives did occur in this pivotal study.

Cologuard uses advanced multitarget, 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.