secwatch.observer — SEC 8-K summary
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Issuer:     Guardant Health, Inc. (GH)
CIK:        0001576280
Form:       8-K
Filed at:   2022-12-15T23:59:59+00:00
Accession:  0001576280-22-000118
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Guardant Health ECLIPSE blood test shows 83% sensitivity for colorectal cancer in 20,000+ patient study
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- ECLIPSE study: 83% sensitivity for CRC detection, 90% specificity vs. negative colonoscopy.
- Advanced adenoma sensitivity at 13%; cfDNA-only test outperformed cfDNA+protein version.
- Plans PMA submission to FDA in Q1 2023; results exceed CMS reimbursement criteria.
- Blood test completion rate 90% vs. 43-66% for stool tests; aims to address 49M unscreened adults.
- Guardant expands test to other cancers including lung cancer; co-CEO cites breakthrough in blood-based screening.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1576280/000157628022000118/0001576280-22-000118-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1576280/000157628022000118/gh-20221215.htm
  HTML page:      https://secwatch.observer/filing/0001576280-22-000118

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