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EGFR Gene Amplification by FISH
2008605
Ordering Recommendation

Aid in prognostication and therapeutic decisions for neoplasms where amplification has been demonstrated. Not recommended for EGFR mutation detection in non-small cell lung carcinoma (NSCLC); preferred test is EGFR Mutation Detection by Pyrosequencing (2002440).

Mnemonic
EGFR FISH
Methodology
Fluorescence in situ Hybridization
Performed
Monday-Friday
Reported
3-7 days
New York DOH Approval Status
This test is New York DOH approved.
Submit With Order
ARUP Consult®
Disease Topics
Specimen Required
Patient Preparation
 
Collect
Tumor tissue. 
Specimen Preparation
Formalin fix (10 percent neutral buffered formalin) and paraffin embed tissue. Protect paraffin block from excessive heat. Transport tissue block or 5 unstained (4-micron thick sections) positively charged slides in a tissue transport kit (ARUP supply #47808) available online through eSupply using ARUP Connect™ or contact ARUP Client Services at (800) 522-2787 (kit recommended but not necessary). (Min 2 slides) 
Storage/Transport Temperature
Room temperature. Also acceptable: Refrigerated. Ship in cooled container during summer months. 
Unacceptable Conditions
Specimens fixed or processed in alternative fixatives (alcohol, Prefer) or heavy metal fixatives (B-4 or B-5). No tumor in tissue. Decalcified specimens. 
Remarks
Include surgical pathology report 
Stability
Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable 
Reference Interval
Components
Reference Interval
EGFR by FISHNonamplified: LSI EGFR:CEP7 Less than 2.0
Amplified: LSI EGFR:CEP7 Greater than or equal to 2.0
EGFR:CEP7By report
EGFR per Cells CountedBy report

Interpretive Data
Refer to report.

Compliance Statement A: For laboratory developed tests using a manufacturer labeled ASR as the reagent providing the specificity of the assay. Analyte Specific Reagent. 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, the FDA has determined that such clearance or approval is not necessary.

Note
Hotline History
N/A
Components
Component Test Code*Component Chart NameLOINC
0049242EGFR by FISH
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
Aliases
  • EGFR
  • EGFR (Her-1)
  • EGFR amplification by FISH
  • EGFR FISH
  • Epidermal Growth Factor Receptor
  • erbB-1
  • Her-1
  • HER1/EGFR