Shield by Guardant Health: status and timeline

Milestones

Next · Full-year 2026 Shield revenue guidance of $218-230M

Shield available for clinical useMay 2022Complete.
FDA approves Shield for colorectal cancer screening29 Jul 2024Complete.
Medicare coverage approved2024Complete.
American Cancer Society adds Shield to screening guidelines27 May 2026Complete.
UnitedHealth Group covers Shield for 40M membersAug 2026Complete.
Higher-throughput workflow approved by FDAQ2 2026Complete.

Most important updates

Guardant raises 2026 guidance as Shield tests double to 66k in Q2; Reveal volume accelerates past 100% growth7 Aug 2026
UnitedHealth Group covers Guardant's Shield blood test for colorectal cancer screening1 Aug 2026
American Cancer Society adds Shield to colorectal cancer screening guidelines27 May 2026
FDA approves Guardant Health's Shield blood test as the first blood-based colorectal cancer screening option29 Jul 2024

Upcoming

2026Full-year 2026 Shield revenue guidance of $218-230M (next)
Q4 2026Cost-reduction workflow deployment (15% lower cost per test)

Current obstacles

Weak at early-stage cancerOnly 55-65% sensitivity at Stage 1. Colonoscopy still best for early detection.
Poor polyp detectionDetects only 13% of dangerous polyps; colonoscopy still required for prevention.

Physics limits

Tumor shedding limits detection of small cancersEarly cancers shed little DNA into blood. Blood tests are inherently less sensitive than direct viewing at early stages.
Methylation marks overlap with normal agingSome methylation changes in normal aging cause false positives. Specificity trade-offs limit sensitivity.

How it works

3 parts

Sample

Blood draw

One vein draw; no sedation or prep.

Detection

Methylation patterns

Circulating cancer DNA is tested for methylation marks that distinguish cancer from normal cells.

Confirmation

Colonoscopy when positive

Positive results must be confirmed by colonoscopy for biopsy and polyp removal.

Spec sheet

Spec	Shield
Colorectal cancer detection rate	83% overall; 55-65% Stage I; 100% Stages II-IV^R (reported)
False positive rate	10% (90% specificity)^R (reported)
Advanced polyp detection	13%^R (reported)
Tests performed Q2 2026	66,000^R (reported)
Q2 2026 Shield revenue	$52.9M^R (reported)

^R reported by the company

Update log

4 updates

About Guardant Health

The team behind Shield

Guardant Health

Shield blood test, colorectal cancer screening

Guardant Health develops blood tests for early cancer detection. Shield is the first FDA-approved blood test for colorectal cancer screening. Reveal detects residual disease after cancer treatment. Guardant went public on NASDAQ (GH) in October 2018.

Shield is the first FDA-approved blood test for colorectal cancer screening, with 83% sensitivity.
Q2 2026: 66k tests, $52.9M revenue, 2026 guidance $218-230M.
American Cancer Society, UnitedHealth (40M members), and Medicare cover Shield.

guardanthealth.com (opens guardanthealth.com)Company profile →

Founded: 201214 yrs
Headquarters: United States
Status: Public
Valuation: public
Staff: ~2,506Dec 2025
Works in: BiotechGenomics & sequencing
Coverage: 2 programs · 4 updateslatest 7 Aug 2026checked 11 Oct
Customers: UnitedHealth Group (opens unitedhealthgroup.com)
Partners: Quest Diagnostics (opens questdiagnostics.com)American Cancer Society (opens cancer.org)
People: Helmy Eltoukhy (opens en.wikipedia.org)Co-founder & Co-CEOAmirAli Talasaz (opens guardanthealth.com)Co-founder & Co-CEO

Spec

Shield

Colorectal cancer detection rate

83% overall; 55-65% Stage I; 100% Stages II-IV^R (reported)

False positive rate

10% (90% specificity)^R (reported)

Advanced polyp detection

13%^R (reported)

Tests performed Q2 2026

66,000^R (reported)

Q2 2026 Shield revenue

$52.9M^R (reported)

Shield

Milestones

Most important updates

Upcoming

Current obstacles

Physics limits

How it works

Blood draw

Methylation patterns

Colonoscopy when positive

Spec sheet

Update log

Fri 7 Aug

Sat 1 Aug

Wed 27 May

Mon 29 Jul 2024

About Guardant Health

Current obstacles

Physics limits

How it works

Blood draw

Methylation patterns

Colonoscopy when positive

Spec sheet

Update log

Fri 7 Aug

Sat 1 Aug

Wed 27 May

Mon 29 Jul 2024

About Guardant Health