regulatory
confidence high
sentiment positive
materiality 0.70
Guardant Health announces March 28, 2024 FDA panel review date for Shield colorectal cancer blood test
Guardant Health, Inc.
- 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.