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 (FISH)

Performed

Monday-Friday

Reported

3-7 days

New York DOH Approval Status
This test is New York DOH approved.
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

By 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
CPT Codes

88377

Components
Component Test Code* Component Chart Name LOINC
3000674 EGFR FISH Reference Number
3000675 EGFR FISH Source
3000676 EGFR/CEP7 FISH Ratio
3000677 Average EGFR Signal Number per Cell
3000678 Average CEP7 Signal Number per Cell
3000679 EGFR FISH Result
3000702 Total Cell Count 78236-7
3000703 Scoring Method 81304-8
* 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 amplification by FISH
  • EGFR FISH
  • EGFR; EGFR (Her-1)
  • Epidermal Growth Factor Receptor
  • erbB-1
  • Her-1
  • HER1/EGFR
EGFR Gene Amplification by FISH