The information provided on EL7.AI is for educational and informational purposes only and does not constitute financial advice.

StocksMediumUpdated•Originally published 4 May 2026•Updated 4 May 2026•

1 min read

FDA Approves Guardant360 CDx as Companion Diagnostic for Pfizer and Arvinas Therapy

Key Facts

1The U.S. FDA approved the Guardant360 CDx liquid biopsy test as a companion diagnostic for the drug VEPPANU.

2VEPPANU was jointly developed by Arvinas, Inc. and Pfizer Inc. for the treatment of advanced breast cancer.

The U.S. Food and Drug Administration (FDA) has granted approval for the Guardant360 CDx liquid biopsy test as a companion diagnostic for the drug VEPPANU (generic name: vepdegestrant). Developed jointly by Pfizer Inc. and Arvinas, Inc., vepdegestrant is designed to treat advanced breast cancer in patients with specific genetic profiles. This regulatory milestone marks the 26th CDx indication for the Guardant360 CDx platform and the company's third ESR1 companion diagnostic approval. The test serves as a critical tool for identifying ESR1 mutations in ER+/HER2- advanced breast cancer patients to determine therapy eligibility. This approval is expected to expand the addressable market for Guardant Health while supporting the commercial rollout of the Pfizer-Arvinas treatment. By integrating advanced diagnostics with targeted therapy, this move reinforces the ongoing shift toward precision medicine in oncology.

about 1 month ago

Version History

Version 1about 1 month ago

What changed: Added the generic drug name (vepdegestrant) and specific milestone metrics for the Guardant360 platform (26th indication and 3rd ESR1 approval).