Shield blood test found most colorectal cancers but few precancers

In FDA's review of Guardant Shield, the blood test detected 83.1% of colorectal cancers and 13.2% of advanced adenomas in 7,861 average-risk adults, with 89.6% specificity.

  • 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

Screening colonoscopy with histopathology in the same adults. Measured.

The system’s part
Not isolated. The study compared the test with colonoscopy findings. It did not compare screening with and without the test or isolate the trained models' part.
Limits
Not yet checked.
Costs and harms
Not yet checked.
Later
Not yet checked.

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Benefit type
Improved Task Accuracy
System
Shield
Made by
Guardant Health, Inc.
Used by
Guardant Health (ECLIPSE study at 265 US sites)
Where
265 sites, United States
Stage
In a pilot
Date
, when the source was published
Kind
Aggregate result
Broad benefit
Identifying Objects, Actions, and Events
Collections
Scrutiny and findings
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 Shield (P230009). Approved 2024-07-26.

    Based on this comparison, Shield sensitivity (true positive fraction) was 83.1% (54/65) for subjects with a histopathological diagnosis of CRC and 13.2% (147/1116) for subjects with a diagnosis of advanced adenoma (Category 2a - 2e, Table 6).

Details

AI system

Workflow

Blood was drawn into Guardant collection tubes and analyzed at the Guardant Health Clinical Laboratory. Each participant also had a screening colonoscopy, with central pathology review of lesions.

Follow-up

Conditions for replication

The adult is 45 or older and at average risk for colorectal cancer. A positive result is followed by colonoscopy.

Entry details

Sector

Healthcare.

Purpose

Guardant Health built Shield to screen adults aged 45 and over at average risk for colorectal cancer with a blood test, with positive results followed by colonoscopy.

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). Shield blood test found most colorectal cancers but few precancers (AIBD-0811). Artificial Intelligence Benefits Database, edition of 31 October 2026. https://petervartanian.xyz/aibd/records/AIBD-0811.html (archived at https://doi.org/10.7910/DVN/AADSII, version 4.0)

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