- Guardant Health's Shield Multi-Cancer Detection test selected for a significant study by the National Cancer Institute.
- The four-year Vanguard Study aims to enroll up to 24,000 participants to evaluate multi-cancer detection technology.
- The Shield test has received FDA Breakthrough Device Designation for its potential in early cancer detection.
Guardant Health, Inc. (GH, Financial) has initiated patient enrollment for the National Cancer Institute's Vanguard Study, which is set to evaluate the efficacy of multi-cancer detection (MCD) technology. This critical study will include up to 24,000 participants and aims to lay the groundwork for future randomized controlled trials by testing the effectiveness of blood tests that can screen for multiple cancer types simultaneously.
Guardant's Shield™ MCD test was chosen for the study due to its robust performance in detecting 10 types of cancer, including lung, breast, and colorectal cancer. This selection follows a thorough review and approval process by the U.S. Food and Drug Administration (FDA), which granted the Shield test an investigational device exemption (IDE).
Participants aged 45-75, who have not been diagnosed with cancer in the past five years, will be included in the Vanguard Study. The initiative aims to gather detailed insights into the utility of MCD tests in identifying cancers early, thereby potentially improving treatment outcomes.
The study's principal investigator, Dr. Scott Ramsey, emphasized the significance of the Vanguard Study in understanding MCD tests' role across diverse populations. The Shield test’s FDA Breakthrough Device Designation highlights its potential to provide a more effective diagnosis compared to current methods, ultimately aiming to reduce cancer mortality rates.
Guardant Health continues to position itself as a leader in precision oncology, leveraging its advanced blood and tissue tests to transform cancer care through early detection and monitoring.
