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Guardant Health's Shield blood test for colorectal cancer receives recommendation for FDA approval
Precision Medicine
May 23, 2024
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Precision Medicine

Precision Medicine

May 23, 2024

Guardant Health's Shield blood test for colorectal cancer receives recommendation for FDA approval

FDA approval

  • Guardant Health has revealed that the Molecular and Clinical Genetics Panel of the FDA's Medical Devices Advisory Committee has endorsed the company's "Shield" blood test for colorectal cancer (CRC), recommending its approval for screening adults aged 45 and above with an average risk of CRC.

  • The Shield test is an in vitro diagnostic test performed on-site to detect CRC-derived alterations in cell-free DNA from blood samples collected through the Guardant Blood Collection Kit. In addition to CRC, the test will also detect advanced adenomas, which should be evaluated through colonoscopy; however, it is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk patients. 

  • The recommendation for the product was given considering the company’s premarket approval (PMA) application, as well as the results of the ECLIPSE trial in which the test demonstrated 83% sensitivity for the detection of CRC, with 90% specificity for advanced neoplasia.

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