India, Sept. 6 -- 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 a...