FDA advisory panel strongly recommends approval of Guardant's Shield blood test for CRC screening

Guardant Health, Inc.

FDA advisory panel voted 8-1 that Shield is safe, 6-3 that it is effective, and 7-2 that benefits outweigh risks.
Shield blood test showed 83% sensitivity for colorectal cancer detection and 90% specificity for advanced neoplasia in ECLIPSE study.
FDA decision on premarket approval expected later in 2024; Shield is on track to become first FDA-approved blood test for CRC screening.
Approximately 50 million eligible Americans are not up-to-date with CRC screening; Shield offers a blood-draw alternative to stool-based tests.

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