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FDA Approves Guardant Health's Shield™ Blood Test as Primary Screening Option for Colorectal Cancer

NextEdge Admin

29 Jul 2024

2 min 50 sec

Colorectal cancer,screening,Genomics,Liquid Biopsy

Guardant Health, Inc. announced that its Shield™ blood test for colorectal cancer (CRC) screening has been approved by the FDA for adults aged 45 and older at average risk. Shield is the first blood test for CRC screening to receive FDA approval and meet Medicare coverage requirements, offering a non-invasive alternative to traditional methods like colonoscopy and stool-based tests.

Colorectal cancer, the second-leading cause of cancer-related deaths in the U.S., is highly treatable if detected early. Despite this, the CRC screening rate in the U.S. is only about 59%, far below the 80% target set by the National Colorectal Cancer Roundtable. Many individuals avoid screening due to the invasive and unpleasant nature of existing options.

Shield aims to bridge this gap by providing a convenient blood test that can be completed during a routine office visit. Since its commercial introduction in May 2022, the adherence rate for the Shield test has been over 90%, significantly higher than the 28-71% completion rates for other screening methods. The test demonstrated 83% sensitivity for detecting CRC and 90% specificity for advanced neoplasia in the ECLIPSE study, involving over 20,000 patients across diverse U.S. populations.

Healthcare experts highlight the importance of Shield in making CRC screening more accessible and increasing early detection rates. With increased screening, the potential to save lives is substantial. Shield is available by prescription and is expected to gain broader insurance coverage following future guideline updates.

AmirAli Talasaz, Guardant Health's co-CEO, emphasized the test's potential to improve screening rates and early cancer detection. Michael Sapienza of the Colorectal Cancer Alliance and Dr. William M. Grady of Fred Hutchinson Cancer Center also praised the test for its accessibility and potential to reach underserved communities.