newsfilter
← Latest News
Business Wire·

Guardant Health Announces Approval in Europe of Guardant360® CDx as Companion Diagnostic for AstraZeneca’s ETCAMAH™ (camizestrant) in Advanced ER-positive Breast Cancer

GH
  • Guardant Health's Guardant360 CDx received CE-marking approval in Europe as a companion diagnostic for ETCAMAH (camizestrant).
  • The approval identifies patients with ER-positive, HER2-negative locally advanced or metastatic breast cancer who may benefit from the treatment.
  • This marks Guardant Health's 31st companion diagnostic approval & the third CDx approval for ETCAMAH.
  • The European approval follows prior regulatory approvals of Guardant360 CDx for ETCAMAH in the United States & Japan.
  • Clinicians can use the test to detect ESR1 mutations via blood draw before disease progression, supporting earlier therapy decisions.
  • Guardant360 CDx is the first FDA-approved liquid biopsy for comprehensive genomic profiling across solid tumors.
  • Guardant Health is headquartered in the US & focuses on precision oncology through blood & tissue tests, real-world data, & AI analytics.