Clinical Scorecard: Industry Insights: Advanced Breast Cancer Diagnostics

At a Glance

Key Highlights

• Emergence of SERD therapies targeting ESR1 mutations
• Challenges in accessibility and reimbursement for liquid biopsy tests
• Advantages of ddPCR over NGS for specific mutation detection
• Need for multiple serial tests for effective disease monitoring
• Collaboration between Biodesix and Bio-Rad to enhance testing capabilities

Guideline-Based Recommendations

Diagnosis

• Use liquid biopsy tests for detecting ESR1 mutations in advanced breast cancer.

Management

• Consider SERD therapies for patients with ESR1 mutations who have developed resistance.

Monitoring & Follow-up

• Implement serial testing for disease monitoring using sensitive assays like ddPCR.

Risks

• High costs and reimbursement challenges may limit access to necessary diagnostic tests.

Patient & Prescribing Data

Patients with advanced breast cancer on hormone therapy showing resistance

SERDs are a promising treatment option for ESR1-mutation-positive patients.

Clinical Best Practices

• Utilize ddPCR for targeted mutation detection due to its sensitivity and quantification capabilities.
• Avoid IHC for resistance monitoring as it does not detect ESR1 mutations effectively.
• Consider decentralized testing solutions to improve patient access to diagnostics.

References

• Biodesix
• Bio-Rad