Official FDA announcement

FDA Panel Recommends Approval of Guardant Health's Shield Blood Test, Stock Jumps 18.6%

May 23, 2024, 10:20 PM

An independent panel of advisers to the U.S. Food and Drug Administration (FDA) has recommended the approval of Guardant Health's blood-based test for detecting colorectal cancer. The test, known as the Shield test, is designed to screen for colon and rectal cancers and has been endorsed by the FDA advisory panel as a non-invasive screening option. The panel voted by large majorities that the test is safe and effective, and that its benefits outweighed its risks. If approved, it will be the first blood screening test for colorectal cancer that meets the requirements for Medicare reimbursement. The panel's recommendation marks a significant step towards FDA approval, although colonoscopies remain the gold standard for diagnosing colon cancers. Guardant Health's stock saw a significant increase of 18.6% in pre-market trading following the panel's endorsement.