FDA approves serial liquid biopsy testing
In SERENA-6, patients who changed treatment following detection of an ESR1 mutation had a 56% lower risk of disease progression or death.
By
Kathryn Wighton
September 8, 2026
Clinical Scorecard: FDA approves serial liquid biopsy testing
At a Glance
Category Detail
Condition Hormone receptor–positive, HER2-negative advanced or metastatic breast cancer Key Mechanisms Detection of ESR1 mutations using Guardant360 CDx liquid biopsy Target Population Patients with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer Care Setting Oncology
Key Highlights
Guardant360 CDx approved for identifying ESR1 mutations before disease progression Testing recommended every 3 months during therapy Patients switching to camizestrant had a 56% lower risk of disease progression or death 47% reduction in deterioration of global health status and quality of life reported Approval based on phase 3 SERENA-6 trial data Guideline-Based Recommendations
Diagnosis
Use Guardant360 CDx for detecting ESR1 mutations in eligible patients Management
Switch to camizestrant upon detection of ESR1 mutations before radiographic progression Monitoring & Follow-up
Conduct liquid biopsy testing every 3 months during therapy Risks
Risk of disease progression or death if aromatase inhibitor therapy is continued Patient & Prescribing Data
Patients with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer undergoing endocrine therapy
Circulating tumor DNA-guided treatment approach improves outcomes
Clinical Best Practices
Implement regular genomic profiling to identify emerging resistance mutations Utilize liquid biopsy for comprehensive genomic alterations across solid tumors Related Resources & Content
