• Test Code:
  • Department:
  • Test Synonyms:
    EGFREGFR Gene Mutation (Exons 18, 19, 20 & 21)
  • CPT Code(s):

Activating mutations in EGFR are present in approximately 10-12% of non-small cell carcinomas of the lung (primarily adenocarcinomas).   Based on a number of phase II and III trials, most EGFR mutations predict a good response to treatment with EGFR inhibitors such as gefitinib and erlotinib.1   The exceptions are insertion mutations in exon 20 and the T790M substitution, which correlate with resistance to these drugs.


  1. Microscopic examination of the specimen and macrodissection of tumor-rich areas.
  2. DNA extraction and purification.
  3. PCR amplification of EGFR coding exons 18, 19, 20 & 21.
  4. Screening for mutations by one of two methods.
    1. Pyrosequencing of each exon
    2. Real-time PCR with high resolution melting curve analysis (HRM), to screen for deletions in exon 19 and insertions in exon 20. DNA sequencing is used to confirm any potential mutations identified by this approach.
  5. Estimated sensitivity: 20% mutant allele.
  6. Estimated specificity: 98% of EGFR mutations reported in non-small cell lung carcinoma.

Specimen Requirements:

  • A paraffin block or
  • 10 unstained sections of tumor (4-5 microns) (15 sections for small biopsies)

Contact Client Services for shipping materials and procedures at (855) 535-1522.

A REQUISITION FORM MUST ACCOMPANY ALL SAMPLES.  Please include detailed clinical information.

Test Performed (Days):

Mon - Fri

Turn Around Time:

10-14 days

Shipment Sensitivity Requirements:

  • Keep specimen cool during transit, but do not ship on dry ice.
  • Please use the cold pack provided in the KDL shipping kit.
  • Ship the specimen overnight express, using the FedEx priority overnight label provided. 
  • Contact Client Services for shipping materials and procedures at (855) 535-1522.


  1. Linardou H, Dahabreh IJ, Bafaloukos D, Kosmidis P, Murray S. Somatic EGFR mutations and efficacy of tyrosine kinase inhibitors in NSCLC. Nat Rev Clin Oncol. 2009 Jun;6(6):352-66.

Additional Info:

The Knight Cancer Institute at Oregon Health & Science University is a pioneer in the field of precision cancer medicine. The institute's director, Brian Druker, M.D., helped prove it was possible to shut down just the cells that enable cancer to grow. This breakthrough has made once-fatal forms of the disease manageable and transformed how cancer is treated. The OHSU Knight Cancer Institute is the only National Cancer Institute-designated Cancer Center between Sacramento and Seattle – an honor earned only by the nation's top cancer centers. It is headquarters for one of the National Cancer Institute's largest research collaboratives, SWOG, in addition to offering the latest treatments and technologies as well as hundreds of research studies and clinical trials.

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