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EGFR Mutation Analysis



Specimen Requirements

  • Formalin-fixed, paraffin-embedded tissue or unstained slides – preferred
  • Fresh snap frozen biopsy or FNA materials

CPT Codes*

81235 X 1
When appropriate, micro dissection CPT code (88381) and pathological review CPT code (G0452) may be added


  • Real-time PCR assay to detect the most common mutations of the EGFR gene
  • Patients with EGFR mutations respond more favorably to EGFR tyrosine kinase inhibitors than those who don’t harbor a mutation 

Clinical Significance

The Epidermal Growth Factor Receptor (EGFR) activates an important pathway that leads to cell proliferation, differentiation, migration/motility, adhesion, protection from apoptosis, enhanced survival and gene transcription. A large body of experimental and clinical work supports the view that EGFR is a relevant target for cancer therapy. The development of selective tyrosine kinase inhibitors has become an important area of drug discovery for the treatment of a variety of solid tumors such as breast, ovarian and colorectal cancers, NSCLC, and carcinoma of the head and neck.

EGFR mutations can be seen in about 10-15% of patients. Patients with EGFR mutations have been reported to respond to selective anti-EGFR tyrosine kinase inhibitors. The EGFR mutation test offered by Clarient will be able to detect these mutations and identify all those patients that may respond to these targeted therapies.


Turnaround Time

2 - 5 Days: 2 - 3 days (Technical) and 3 - 5 days (Global)


  1. Cappuzzo F, Finocchiaro G, Metro G, et al. Clinical experience with gefitinib: an update. Crit Rev Oncol Hematol 2006;58:31-45.
  2. Paez JG, Janne PA, Lee JC, et al. EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy. Science 2004;304:1497-500
  3. Sequist LV, Joshi VA, Janne PA, et al. Response to treatment and survival of patients with non-small cell lung cancer undergoing somatic EGFR mutation testing. Oncologist 2007;12:90-8
  4. Ji H, Li D, Chen L, et al. The impact of human EGFR kinase domain mutations on lung tumorigenesis and in vivo sensitivity to EGFR-targeted therapies.Cancer Cell 2006;9:485-95

Molecular Marker EGFR Pathway 


*These CPT codes are general codes frequently used for these tests. The correct CPT code should be selected on a case-by-case basis by a qualified coder.
†Please note the information provided is intended as a guideline. Turnaround time is measured from the time of receipt of the specimen at our laboratory to the time the test result is made available to the client. As with all healthcare matters, the facts of a particular case may necessitate a turnaround time that is longer than stated above, the times mentioned above are our laboratory times for most, standard cases.