---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-146510"
form_type: "8-K"
ticker: "GH"
cik: "0001576280"
company_name: "Guardant Health, Inc."
filed_at: "2024-05-24T23:59:59+00:00"
generated_at: "2026-06-01T08:42:58.582533+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA advisory panel strongly recommends approval of Guardant's Shield blood test for CRC screening

## Summary
- FDA advisory panel voted 8-1 that Shield is safe, 6-3 that it is effective, and 7-2 that benefits outweigh risks.
- Shield blood test showed 83% sensitivity for colorectal cancer detection and 90% specificity for advanced neoplasia in ECLIPSE study.
- FDA decision on premarket approval expected later in 2024; Shield is on track to become first FDA-approved blood test for CRC screening.
- Approximately 50 million eligible Americans are not up-to-date with CRC screening; Shield offers a blood-draw alternative to stool-based tests.

## SEC filing metadata
- accession: 0001193125-24-146510
- form_type: 8-K
- ticker: GH
- cik: 0001576280
- company_name: Guardant Health, Inc.
- filed_at: 2024-05-24T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1576280/000119312524146510/0001193125-24-146510-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1576280/000119312524146510/d843201d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-146510
- JSON: https://secwatch.observer/filing/0001193125-24-146510.json
- Plain text: https://secwatch.observer/filing/0001193125-24-146510.txt

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