Key Highlights
- FDA approves Shield™ as the first blood test for primary CRC screening in adults 45+ at average risk.
- Convenient alternative to colonoscopy and stool-based tests, completed with a simple blood draw.
- High adherence rate: Over 90% of patients complete the Shield™ test.
- ECLIPSE study results: 83% sensitivity for CRC detection, 90% specificity for advanced neoplasia.
Source: Business Wire
Notable Quotes
- “The FDA’s approval of the Shield blood test marks a tremendous leap forward, offering a compelling new solution to close this gap.” — Daniel Chung, MD, gastroenterologist at Massachusetts General Hospital and Professor of Medicine at Harvard Medical School
- “Shield can help improve colorectal cancer screening rates so we can detect more cancers at an early stage, when they are treatable.” — AmirAli Talasaz, co-CEO at Guardant Health
- “Guardant Health’s Shield test checks all three of these boxes and is truly a welcomed addition to the screening options currently available.” — Michael Sapienza, CEO at the Colorectal Cancer Alliance
SoHC's Take
The FDA approval of Guardant Health’s Shield™ blood test represents a significant milestone in colorectal cancer screening. By providing a non-invasive, highly accessible option, Shield™ addresses key barriers to screening, such as the invasiveness and inconvenience of traditional methods like colonoscopy and stool-based tests. This innovation is poised to significantly increase screening rates and early detection, ultimately saving lives. The robust data from the ECLIPSE study underscores the test’s efficacy, aligning with current screening guidelines and ensuring broad acceptance among healthcare providers. This development is a game-changer in the fight against colorectal cancer, offering a much-needed alternative that meets the needs of a diverse patient population.
