# Cologuard

Source: https://onco.cc/drugs/cologuard/  
OnCo record `cologuard` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A home stool test done every three years that looks for cancer DNA and hidden blood; a positive result means you need a colonoscopy.

## Summary

Cologuard (Exact Sciences) was approved by the FDA on 11 August 2014 (PMA P130017) for average-risk adults, the first stool DNA screening test. In the pivotal DeeP-C study (NEJM 2014, 9,989 participants) sensitivity for colorectal cancer was 92.3% versus 73.8% for FIT, sensitivity for advanced precancerous lesions 42.4% versus 23.8%, and specificity 86.6% versus 94.9%. It is a USPSTF-endorsed option at a three-year interval, covered by Medicare, and by 2024 more than 16 million tests had been performed. Its weakness is the false-positive rate, which sends about one in eight negative-for-cancer people to colonoscopy, and its limited detection of polyps compared with colonoscopy.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-10
- Tags: test
- Brand: Cologuard
- Modality: Multitarget stool DNA colorectal cancer screening test
- Mechanism: Stool sample analysed for methylated NDRG4 and BMP3, mutant KRAS, and faecal haemoglobin, combined by an algorithm into a positive or negative result.
- Approvals: US 2014: Colorectal cancer screening in average-risk adults aged 50 and older (later 45 and older)

## Notes

- What a result means: negative means repeat in three years; positive means a diagnostic colonoscopy, and most positives turn out not to be cancer.

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Cologuard
- FDA PMA P130017: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130017
- DeeP-C (NEJM 2014): https://doi.org/10.1056/NEJMoa1311194
- USPSTF colorectal cancer screening (2021): https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/colorectal-cancer-screening

## Connected records

- drugs: [Cologuard Plus](https://onco.cc/drugs/cologuard-plus/), [Shield](https://onco.cc/drugs/shield/)
- cancers: [Colorectal cancer](https://onco.cc/cancers/colorectal/), [Early-onset colorectal cancer (under 50)](https://onco.cc/cancers/early-onset-colorectal/)
- technologies: [Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood)](https://onco.cc/technologies/colorectal-screening/), [DNA methylation profiling](https://onco.cc/technologies/methylation-profiling/), [Multitarget stool RNA test (ColoSense)](https://onco.cc/technologies/multitarget-stool-rna-test/)
- companies: [Exact Sciences (Abbott)](https://onco.cc/companies/exact-sciences/)
- terms: [Faecal immunochemical test (FIT)](https://onco.cc/terms/fit-test/), [Positive predictive value (PPV)](https://onco.cc/terms/ppv/), [Screening](https://onco.cc/terms/screening/)
- trials: [DeeP-C](https://onco.cc/trials/deep-c/)
- key papers: [Multitarget stool DNA testing for colorectal-cancer screening](https://onco.cc/key-papers/paper-imperiale-multitarget-stool-dna-screening-nejm-2014/)
- ideas: [Treat screening uptake, not test sensitivity, as the thing to optimise, and settle the age extension with a trial rather than a model](https://onco.cc/ideas/idea-crc-screening-uptake-and-age-extension/)

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JSON: https://onco.cc/api/v1/entities/cologuard.json