Yahoo · Sep 18, 2026
Guardant Health (GH) Lands First FDA Cleared Breast Cancer Liquid Biopsy Role
Guardant Health (NasdaqGS:GH) received FDA approval for its Guardant360 CDx liquid biopsy as a companion diagnostic in advanced HR-positive, HER2-negative breast cancer. The decision makes Guardant360 CDx the first FDA approved liquid biopsy companion diagnostic for longitudinal ctDNA testing in breast cancer care. The approval is supported by clinical trial data where early detection of ESR1 mutations using Guardant360 CDx informed treatment changes for patients. The Guardant360 CDx breast...

