---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-298718"
form_type: "8-K"
ticker: "GH"
cik: "0001576280"
company_name: "Guardant Health, Inc."
filed_at: "2023-12-19T23:59:59+00:00"
generated_at: "2026-06-07T10:33:33.348850+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Guardant Health announces March 28, 2024 FDA panel review date for Shield colorectal cancer blood test

## Summary
- FDA's Molecular and Clinical Genetics Panel tentatively set to review Shield PMA on March 28, 2024, subject to confirmation.
- Shield blood test data derived from ECLIPSE study of over 20,000 average-risk adults for colorectal cancer detection.
- Co-CEO AmirAli Talasaz states proposed timing aligns with completing PMA process and launching Shield IVD in 2024.

## SEC filing metadata
- accession: 0001193125-23-298718
- form_type: 8-K
- ticker: GH
- cik: 0001576280
- company_name: Guardant Health, Inc.
- filed_at: 2023-12-19T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1576280/000119312523298718/0001193125-23-298718-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1576280/000119312523298718/d719875d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-298718
- JSON: https://secwatch.observer/filing/0001193125-23-298718.json
- Plain text: https://secwatch.observer/filing/0001193125-23-298718.txt

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