Significantly improved sensitivity over a leading fecal immunochemical test (FIT)* for detecting colorectal cancer and precancer1,2

Sensitivity Cologuard Fit
(OC FIT-CHEK, Polymedco, Inc.)
All CRC (stages I to IV)†‡ 92% 74%
CRC stages I to II1,3†‡ 94% 70%
Advanced precancer1 42% 24%
High-grade dysplasia1 69% 46%
Sessile serrated polyp ≥ 1cm1 42% 5%
Proximal cancer14 90% 67%
≥3 cm precancer12 68% 42%

 

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

Study design: Results from 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. In the pivotal study, screening colonoscopy was the reference method.1 Cologuard performance in patients aged 45 to 49 years was estimated by sub-group analysis of near-age groups.

The science behind Cologuard

Based on breakthrough stool DNA (sDNA) technology1,2

The proprietary sDNA technology of Cologuard can analyze and detect 11 distinct biomarkers that identify colorectal cancer and precancer.

Cologuard

  • 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

FIT*

  • Detects 1 biomarker
  • Only detects hemoglobin in stool
  • Detects hemoglobin from polyps or lesions that bleed intermittently
  • Does not detect right-sided cancers as well as left-sided

Cologuard is not for high-risk individuals, including patients with a personal history of colorectal cancer and adenomas; 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 have a family history of colorectal cancer, or certain hereditary syndromes.