Guardant Health's Guardant360 CDx Receives FDA Approval for Breast Cancer Treatment
Guardant Health, a precision oncology company, has announced that the U.S. Food and Drug Administration (FDA) has approved its Guardant360 CDx liquid biopsy test as a companion diagnostic for VEPPANU (vepdegestrant). This approval is significant for patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer. VEPPANU, developed by Arvinas and Pfizer, is designed to target and degrade the estrogen receptor, providing a targeted treatment option for patients whose cancers are driven by ESR1 mutations. The Guardant360 CDx test allows for a non-invasive, blood-based method to identify patients eligible for this treatment, marking the third ESR1 companion diagnostic approval for Guardant Health. 
