LONDON (dpa-AFX) - Guardant Health Inc. (GH) announced that the U.S. Food and Drug Administration approved Guardant360 CDx as a companion diagnostic or CDx to identify patients with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer harboring tumors with ESR1 mutations before radiographic progression. These patients may benefit from treatment with ETCAMAH (camizestrant), AstraZeneca's next-generation oral selective estrogen receptor degrader or SERD.
The approval makes Guardant360 CDx the first FDA-approved liquid biopsy CDx for longitudinal testing in breast cancer, representing a major shift in clinical practice. Instead of therapy selection and switching after radiographic progression, clinicians can now adopt adaptive cancer management and early interception using pre-radiographic progression circulating tumor DNA (ctDNA) testing.
The latest FDA approval marks the 29th CDx indication for Guardant360 CDx across multiple tumor types globally, underscoring its growing role in precision oncology.
GH closed Friday's regular trading at $161.41 up $0.37 or 0.23%.
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