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Test Name:
Epidermal Growth Factor Receptor (EGFR) Gene Amplification, by FISH, Paraffin Block

• SBMF No:
  44904
• Performance Lab Name:
  ARUP Laboratories
• Test Mnemonic:
  EGFR FISH
• ABN:
  Not required
• CPT Code:
  88368x2
• LOINC Code:
  
• Ref Lab Test No:
  0049234
• Also Known As:
  EGFR by FISH
  Her-1
• Spec Type:
  Tumor tissue
• Spec Container:
  Paraffin-embedded, formalin-fixed tissue block
• Pref Vol:
  One block or 5 unstained 5 micron slides
• Min Vol:
  3 slides
• Spec Collect:
  Collected by physician
• Spec Process:
  Formalin fix (10% neutral buffered formalin) and paraffin embed tissue. Transport tissue block or unstained 5 micron slides.
• Spec Store Transport:
  Room temperature or refrigerated
  Protect paraffin block from excessive heat
  Ship in cooled container during summer months
• Spec Stability:
  Room temperature (20-20°C): Indefinitely
  Refrigerated (2-8°C): Indefinitely
  Frozen (-20°C): Unacceptable
• Spec Reject:
  No tumor in tissue
  Frozen specimen
  Specimen fixed/processed in alternative fixative (alcohol, Prefer®) or heavy metal fixatives (B-4 or B-5)
  Decalcified specimens
• Spec Remarks:
  Only tissue that is clearly carcinoma (established by histopathologic criteria) should be tested
  Include surgical pathology report
• Methodology:
  Fluorescent In Situ Hybridization (FISH)
• Clinical Significance:
  Refer to:
  
• Reference Range:
  

  EGFR by FISH
  Nonamplified: LSI EGFR:CEP7 Less than 2.0
  Amplified: LSI EGFR:CEP7 Greater than or equal to 2.0

  EGFR:CEP7
  By report

  EGFR per Cells Counted Ratio
  By report

• Additional Test Info:
  ASR Compliance Statement:
  Analyte specific reagents (ASR) are used in many laboratory tests necessary for standard medical care and generally do not require U.S. Food and Drug Administration (FDA) approval or clearance. This test was developed and its performance characteristics determined by ARUP Laboratories. The U.S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. This test should not be regarded as investigational or for research use.
• Day Run:
  Weekly
• Time Reported:
  Within 2 weeks
• Test Type:
  AP