Advisory Committee Strongly Recommends Approval of Guardant Health's Shield Blood Test for Colorectal Cancer Screening

Advisory Committee Strongly Recommends Approval of Guardant Health's Shield Blood Test for Colorectal Cancer Screening

The Molecular and Clinical Genetics Panel of the U.S. Food and Drug Administration's (FDA) Medical Devices Advisory Committee has strongly recommended the FDA approve Guardant Health Inc.'s Shield blood test for colorectal cancer (CRC) screening in adults aged 45 and older at average risk for the disease. The recommendation signals the committee's conclusion that the benefits of the blood test outweigh potential risks after considering the test's safety and effectiveness with its proposed usage. The committee's recommendation is non-binding, and the FDA is expected to make a decision on approval later this year.

The Shield blood test is a non-invasive option that overcomes barriers associated with current non-invasive screening tests. The test effectively detects cancer at an early stage when it is most treatable. Providing people with this blood test option alongside other non-invasive stool tests may increase the rate of CRC screening and potentially reduce preventable CRC deaths.

Colorectal cancer is the second-leading cause of cancer-related deaths in the U.S., with a 91% five-year survival rate when caught at stage I (localized). Despite the importance of detecting colorectal cancer early, screening rates among eligible Americans are low. Current primary non-invasive screening options include stool-based tests, which have proven efficacy in detecting CRC, but these tests have barriers that can impact adherence.

The panel's recommendation is based on Guardant's premarket approval application for Shield, including the results of the pivotal ECLIPSE study evaluating the performance of the test for detecting CRC in average-risk adults. The study demonstrated that Shield has 83% sensitivity for the detection of CRC, with 90% specificity for advanced neoplasia. This performance is within range of existing stool-based tests used as primary CRC screening options, in which overall sensitivity ranges from 67% to 92%.

AmirAli Talasaz, co-CEO of Guardant Health, said the committee's strong support for the approval of Shield reinforces the importance of a blood test option in improving CRC screening rates among average-risk individuals. He noted that despite the effectiveness of existing screening methods, obstacles such as handling stool and completing the tests deters many Americans from screening. Shield aims to overcome these obstacles and provide a convenient, non-invasive option to increase screening rates and reduce preventable CRC deaths.

About Guardant Health Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data, and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and helping doctors select the best treatment for patients with advanced cancer.

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