EGFR Mutation Analysis, Tissue

Test Mnemonic


CPT Codes

  • 81235 - QTY (1)



Performing Laboratory

Cleveland Clinic Laboratories

Specimen Requirements

Volume Type Container Collect Temperature Transport Temperature Special Instructions
OtherBlock, Formalin fixed paraffinClean containerAmbient Block, Formalin fixed parafin OR 8-10 unstained slides from formalin fixed block cut in 5 micron sections. The specimen submitted for analysis should contain >20% tumor cells. Please include H&E slide and a copy of pathology report.

Days Performed

1 day per week

Turnaround Time

7 - 10 days


Name Description
Polymerase Chain Reaction (PCR) 

Special Info

Submit a surgical pathology requisition for tissue and cytopathology cell block specimens. NOTE: EGFR Mutation Analysis on cytopathology FNA's is a different test and is ordered as EGFR, Mutation Analysis, CELL PELLET.

Clinical Info

Cancers of the lung are aggressive diseases, accounting for approximately 30% of all cancer deaths in the US in 2009, with the overall survival rate of patients with metastatic disease <15% . Different histological subtypes exist; Small-Cell Lung Cancer (SCLC) which accounts for approximately 20% of lung cancer cases, and Non-Small-Cell Lung Cancer (NSCLC), which accounts for the majority of lung cancer cases in the US. NSCLC includes adenocarcinoma, squamous cell carcinoma, and undifferentiated large-cell carincoma. NSCLC tumors are also categorized according to molecular criteria. EGFR (epidermal growth factor receptor)-mutant NSCLC has been defined as a distinct, clinically relevant molecularly defined subset of lung cancer. EGFR-mutant tumors are histologically similar to adenocarcinomas, and are often associated with better prognosis than EGFR wild-type tumors, due in the most part to their increased sensitivity to Tyrosine Kinase Inhibitors (TKIs) such as erlotinib (Tarceva; Genentech/OSI Pharmaceuticals) or gefitinib (Iressa; AstraZeneca). However, not all mutations in the EGFR gene confer sensitivity to TKIs, and primary resistance is still observed. In addition to this, acquired resistance can develop after prolonged TKI exposure, which limits the effectiveness of this type of treatment.

Technical Brief