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confidence high
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materiality 0.80
Guardant Health ECLIPSE blood test shows 83% sensitivity for colorectal cancer in 20,000+ patient study
Guardant Health, Inc.
- 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.