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.
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By
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Kathryn Wighton
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September 8, 2026
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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
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