secwatch.observer — SEC 8-K summary
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Issuer:     Guardant Health, Inc. (GH)
CIK:        0001576280
Form:       8-K
Filed at:   2023-12-19T23:59:59+00:00
Accession:  0001193125-23-298718
Event type: regulatory
Sentiment:  positive
Materiality: 0.70
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1576280/000119312523298718/0001193125-23-298718-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1576280/000119312523298718/d719875d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-298718

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer