Guardant Health Receives FDA Approval for Guardant360® CDx
Guardant Health has announced FDA approval for its Guardant360® CDx liquid biopsy test as a companion diagnostic for VEPPANU (vepdegestrant), a treatment developed by Arvinas and Pfizer, for patients with ER+/HER2- advanced breast cancer exhibiting ESR1 mutations.
PALO ALTO, Calif.–(BUSINESS WIRE)–Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved the Guardant360® CDx liquid biopsy test as a companion diagnostic for VEPPANU (vepdegestrant). VEPPANU, jointly developed by Arvinas, Inc. and Pfizer Inc., is approved for the treatment of adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor