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Guardant Health Receives FDA Approval for Guardant360® CDx as a Companion Diagnostic for Arvinas and Pfizer’s VEPPANU (vepdegestrant) for Patients with ER+/HER2- Advanced Breast Cancer with ESR1 Mutations

$GHPress releaseMay 4, 2026, 8:05 AM ETRead the release

Guardant Health received FDA approval for its Guardant360 CDx test as a companion diagnostic for Arvinas and Pfizer’s VEPPANU in ER+/HER2- advanced breast cancer. The blood-based test identifies patients with ESR1 mutations eligible for the new PROTAC therapy, representing the third ESR1 companion diagnostic approval for Guardant.

Key figures

Covered lives
300000000
Esr1 companion diagnostics
3
Companion diagnostic indications
26

AI analysis

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    GH: Guardant Health Receives FDA Approval for Guardant360® CDx as a Companion Diagnostic for Arvinas and Pfizer’s VEPPANU (vepdegestrant) for Patients with ER+/HER2- Advanced Breast Cancer with ESR1 Mutations — AI Analysis | Signal8