Guardant Health’s Guardant360 CDx Secures FDA Approval as VEPPANU Companion Diagnostic for ESR1-Mutant Breast Cancer
Guardant Health announced FDA approval of Guardant360 CDx as companion diagnostic for VEPPANU, enabling non-invasive detection of ESR1 mutations in ER+/HER2- advanced breast cancer patients post–endocrine therapy. The approval marks Guardant360 CDx’s 26th companion diagnostic indication across tumor types and extends payer coverage to over 300 million lives.
1. FDA Approval and Indication
Guardant Health announced FDA approval of its Guardant360 CDx liquid biopsy as a companion diagnostic for vepdegestrant (VEPPANU) in adults with ER+/HER2- advanced or metastatic breast cancer harboring ESR1 mutations after at least one line of endocrine therapy.
2. Guardant360 CDx Platform Growth
This approval marks the third FDA companion diagnostic for ESR1 mutations and the 26th overall indication for Guardant360 CDx across solid tumors, underlining its expanding role in precision oncology and non-invasive genomic profiling.
3. Market Reach and Patient Identification
The test’s blood-based design enables earlier detection of resistance mutations, and broad Medicare and commercial payer coverage now extends to over 300 million covered lives, potentially accelerating patient identification and treatment initiation.