- 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
(OC FIT-CHEK, Polymedco, Inc.)
|All CRC (stages I to IV)†‡||92%||74%|
|CRC stages I to II1,3†‡||94%||70%|
|Sessile serrated polyp ≥ 1cm1||42%||5%|
|≥3 cm precancer12||68%||42%|
• 87% specificity overall with Cologuard1§ 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 proprietary sDNA technology of Cologuard can analyze and detect 11 distinct biomarkers that identify colorectal cancer and precancer.
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.