FDA clears Guardant Shield
The FDA approved Guardant Shield — a blood-based colorectal cancer screening test for adults 45 and older — expanding noninvasive screening options. This approval further embeds molecular platforms into routine cancer screening pathways and could shift screening workflows in hospitals and labs. (targetedonc.com)
Shield was granted PMA P230009 on July 26, 2024, with Guardant Health listed as the PMA applicant and Redwood City as the company address. (fda.gov) The FDA executive summary specifies Shield analyzes plasma-derived cell-free DNA for somatic mutations, methylation changes and fragmentation patterns using the Guardant blood collection system. Guardant reported a clinical update for the Shield algorithm (V2) showing an overall CRC sensitivity of 84% and specificity of 90%, with stage I sensitivity reported at 62% in an expanded ECLIPSE-derived cohort. (businesswire.com) Medicare coverage falls under NCD 210.3, which designates blood-based CRC screening tests as covered once every three years when performed in a CLIA-certified lab and ordered by a treating physician; Shield also received ADLT status and an initial Medicare reimbursement rate of $1,495 during a nine-month ADLT period starting April 1, 2025. (cms.gov) Guardant announced a strategic collaboration with Quest Diagnostics to make Shield orderable through Quest’s national test-ordering and collection network and accessible via existing Quest accounts and EHR connectivity, with the partnership announced in March 2026. (investors.guardanthealth.com) At the FDA advisory meeting, the Molecular and Clinical Genetics Panel voted that benefits outweigh risks 7–2, deemed Shield safe 8–1, and judged it effective by a 6–3 margin during its review. (insideprecisionmedicine.com)
