EGFR Mutation Analysis

Test ID: M EGFR CPT Code: 81235

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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.

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

Oncology Pathology Requisition

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

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