EGFR Mutation Analysis
Expected Turnaround Time
14 days
Stated turn-around-times (TATs) are for clinical use only and subject to change based on biopharma protocol requirements. Final TATs will be specified in the biopharma study contract.
Stated turn-around-times (TATs) are for clinical use only and subject to change based on biopharma protocol requirements. Final TATs will be specified in the biopharma study contract.
Clinical Information
This FDA-approved assay is useful in determining eligibility for tyrosine kinase inhibitor (TKI) therapy in patients with non-small cell lung cancer (NSCLC). The EGFR mutation is present in 10-15% of lung adenocarcinomas, and predicts response to drugs such as erlotinib. This test covers actionable regions of exons 18-21, including the T790M mutation which predicts resistance to TKI therapy.
Requisition Forms
Specimen Requirements
Specimen Requirements
- Paraffin Embedded Tissue Block: FFPE Block, 10% NBF Fixed
- Paraffin Embedded Tissue Slides: 5 slides or scrolls (minimum 5-10 μM), 10% NBF Fixed
Specimen Stability
Indefinite
Storage Requirements
15°C to 25°C
Shipping Conditions
Ambient
Shipping Recommendations
AMBIENT, Use a refrigerated (NOT FROZEN) gel pack in the shipment to protect from extreme temperatures. Separate gel pack from specimen
Specimen Rejection Criteria
Improper specimen labeling; Insufficient tissue; Insufficient tumor burden; Insufficient DNA isolated
Test Details
Synonyms
ERBB1
Keywords
Companion Diagnostics, Molecular Diagnostics, Oncology, Mutation Analysis, DNA Sequencing, Lung Cancer, Genomics
Test Method
Real-time polymerase chain reaction (RT-PCR)
Methodology Category
Molecular
Regulatory Status
IVD, FDA-Approved Companion Diagnostic (CDx)
Special Considerations
- FFPE block preferred; unbaked slides acceptable.
- Include a surgical pathology report with the sample
Associations
NSCLC