---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-186674"
form_type: "8-K"
ticker: "GH"
cik: "0001576280"
company_name: "Guardant Health, Inc."
filed_at: "2024-07-29T23:59:59+00:00"
generated_at: "2026-05-31T15:43:21.145435+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# Guardant Health's Shield blood test gets FDA approval for colorectal cancer screening in ages 45+

## Summary
- Shield is first blood test approved by FDA as a primary screening option for colorectal cancer.
- Meets CMS requirements for Medicare coverage; expected to be covered for eligible Medicare beneficiaries.
- ECLIPSE study showed 83% sensitivity for CRC detection and 90% specificity for advanced neoplasia.
- Real-world adherence rate for Shield is over 90%, compared to 28-71% for other screening methods.
- Company to launch test soon; commercial insurance coverage expected after future guideline inclusion.

## SEC filing metadata
- accession: 0001193125-24-186674
- form_type: 8-K
- ticker: GH
- cik: 0001576280
- company_name: Guardant Health, Inc.
- filed_at: 2024-07-29T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1576280/000119312524186674/0001193125-24-186674-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1576280/000119312524186674/d869952d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-186674
- JSON: https://secwatch.observer/filing/0001193125-24-186674.json
- Plain text: https://secwatch.observer/filing/0001193125-24-186674.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.