regulatory
confidence high
sentiment positive
materiality 0.90
Guardant Health's Shield blood test gets FDA approval for colorectal cancer screening in ages 45+
Guardant Health, Inc.
- Shield is first blood test approved by FDA as a primary screening option for colorectal cancer.
- Meets CMS requirements for Medicare coverage; expected to be covered for eligible Medicare beneficiaries.
- ECLIPSE study showed 83% sensitivity for CRC detection and 90% specificity for advanced neoplasia.
- Real-world adherence rate for Shield is over 90%, compared to 28-71% for other screening methods.
- Company to launch test soon; commercial insurance coverage expected after future guideline inclusion.