Guardant Health wins FDA nod for Guardant360 CDx as breast cancer companion diagnostic for AstraZeneca camizestrant
GH•FDA clears Guardant360 CDx as companion diagnostic
- FDA cleared Guardant Health’s Guardant360 CDx as a companion diagnostic for AstraZeneca’s ETCAMAH (camizestrant) in advanced breast cancer.
- The test identifies HR-positive, HER2-negative patients with ESR1 mutations before radiographic progression for camizestrant treatment.
- Approval was supported by SERENA-6 data showing a 56% lower risk of progression or death with an early switch to camizestrant.
