EGFR Mutational Analysis
GENERAL INFORMATION
Test Name:
CPT Code(s):
Methodology:
Polymerase chain reaction (PCR)
Days of Week Performed:
M,Tu, W, Th, F
Routine TAT:
24 hours (excluding weekends and holidays)
Reference Range(s):
Negative for mutation
Clinical Utility:
Determining EGFR mutation status is useful in identifying patient eligibility for tyrosine kinase inhibitor (TKI) therapy. Specific oncogenic EGFR mutations in non-small cell lung carcinomas are associated with clinical response or resistance to certain TKIs. The EGFR mutation analysis panel includes assessment of 51 biomarker mutations in Exons 18, 19, 20 and 21 of the EGFR gene.
Collection and Handing
Collection Instructions:
Tumor Tissue: Formalin fix (10 percent neutral buffered formalin) and paraffin embed tissue (FFPE). Testing can be performed off FFPE tissue block or utilizing an unstained 5 micron slide. Testing requires at least 10% neoplastic cellularity.
Collection Containers:
NA
Specimen Transport Requirements:
Room temperature. Protect tissue block from excessive heat.
Appropriate Clinical Data:
In house FFPE block retention follows College of American Pathologists (CAP) requirements.
