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EGFR Mutation Analysis by Next Generation Sequencing

Test Code

M EGFR

Test Synonyms

ERBB1

Associations

NSCLC

Methodology

Next Generation Sequencing Targeted HotSpots
QIAGEN® Human Tumor Actionable Mutations Panel (GeneRead™ DNAseq Targeted Panels V2) for targeted enrichment

Turnaround Time

7-10 days

Specimen Requirements

Formalin Fixed Paraffin Embedded tissue block or slides (3-5 slides at 5 micron minimum) NOTE: Include a surgical pathology report with the sample
5.0 mL (min. 3.0 mL) whole blood EDTA, Sodium Heparin or ACD
3.0 mL (min. 1.0 mL) bone marrow EDTA, Sodium Heparin or ACD

Specimen Stability
Indefinite at ambient temperature (18-25°C) Whole blood and Bone Marrow stable at 18-25°C for 72 hours or 4°C for up to 7 days
Storage & Handling

Ship at ambient temperature, cool in summer. (Do not allow cool/refrigerated pack to directly contact sample)

Causes for Rejection

Improper specimen labeling; Insufficient sample volume; Clotted specimen; Specimen older than 7 days

Description

This sequencing panel 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.

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References
  1. Passaro A, Gori B, de Marinis F. (2013) Afatinib as first-line treatment for patients with advanced non-small-cell lung cancer harboring EGFR mutations: focus on LUX-lung 3 and LUX-Lung 6 phase III trials. J Thorac Dis 5(4):383-384
  2. Cappuzzo F, Finocchiaro G, Metro G, et al. (2006)Clinical experience with gefitinib: an update. Crit Rev Oncol Hematol 58:31-45
  3. Paez JG, Janne PA, Lee JC, et al. (2004) EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy. Science 304:1497-500
  4. Sequist LV, Joshi VA, Janne PA, et al. (2007) Response to treatment and survival of patients with non-small cell lung cancer undergoing somatic EGFR mutation testing. Oncologist 12:90-8
  5. Ji H, Li D, Chen L, et al.(2006) The impact of human EGFR kinase domain mutations on lung tumorigenesis and in vivo sensitivity to EGFR-targeted therapies.Cancer Cell.9:485-95
Trademarks

Qiagene and GeneRead are trademarks of Qiagen