Cologuard caught more colorectal cancers than a standard stool test

In FDA's review of Cologuard, the stool DNA test detected 92.3% of colorectal cancers against 73.8% for FIT in 9,989 adults. Its specificity was 86.6% against 94.9%.

  • Not rated an organization

    Every participant also had a colonoscopy, so the test changed no screening decision in the study.

Depth runs from 1, a convenience or time saved, to 5, a life or a livelihood preserved.

Status
Intended benefit.
Evidence

foundstudiedreportedclaimed

An independent regulatory document supports the benefit.

Compared with

A commercial fecal immunochemical test (OC FIT-CHEK) in the same adults. Measured.

Without the system
Sensitivity 73.8% for colorectal cancer, specificity 94.9%
With it
Sensitivity 92.3%, specificity 86.6%
The system’s part
Not isolated. The study compared Cologuard with a separate commercial FIT and with colonoscopy, and it did not isolate the scoring model's part. The model was fitted to 953 samples by stepwise selection, which the summary does not call machine learning or artificial intelligence.
Limits
Not yet checked.
Costs and harms
Not yet checked.
Later
Not yet checked.

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Benefit type
Improved Task Accuracy
System
Cologuard
Made by
Exact Sciences Corporation
Used by
Exact Sciences (DeeP-C study at 90 sites in the United States and Canada)
Where
90 sites in the United States and Canada
Stage
In a pilot
Date
, when the source was published
Kind
Aggregate result
Broad benefit
Identifying Objects, Actions, and Events
Collections
Scrutiny and findings, Cross-border records
Last revised
31 October 2026

Sources

  1. Regulatory document, by authors with no tie to the system.

    U.S. Food and Drug Administration, Center for Devices and Radiological Health. Summary of Safety and Effectiveness Data for Cologuard (P130017). Approved 2014-08-11.

    Sensitivity for CRC was greater for Cologuard (92.3%, 60/65) than for FIT (73.8%, 48/65) (Table 12 and Figure 1), for a difference of 18.5%.

Details

AI system

Workflow

Participants collected stool with a kit, and Cologuard samples were batch tested at one of three laboratories. Laboratory technicians ran the test blinded to colonoscopy and FIT results.

Follow-up

Conditions for replication

The adult is 50 or older and at average risk for colorectal cancer. A positive result is followed by colonoscopy.

Entry details

Sector

Healthcare.

Purpose

Exact Sciences built Cologuard to screen adults aged 50 and over at average risk for colorectal cancer by detecting DNA markers and hidden blood in stool.

Not yet checked: model, release, provider, role, configuration, inputs and outputs, autonomy, human oversight, AI contribution, beneficiaries, reach, distribution and access, duration, every measurement question, every money question, ownership and control, dependencies, cross-border connections, geopolitical implications, replication attempts, availability, institutional decision, grounds, action and result, success criterion, every evidence question, observed or intended, alternative assessments, related entries, other identifiers, category mappings.

Cite this record

Peter H. Vartanian. (2026). Cologuard caught more colorectal cancers than a standard stool test (AIBD-0812). Artificial Intelligence Benefits Database, edition of 31 October 2026. https://petervartanian.xyz/aibd/records/AIBD-0812.html (archived at https://doi.org/10.7910/DVN/AADSII, version 4.0)

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