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
If multiple specimens (blocks or slides) are sent to ARUP, they must be accompanied by one of the following: an order comment indicating that the ARUP pathologist should choose the specimen most appropriate for testing (e.g., "Choose best block"), or individual orders for each sample submitted. A Pathologist Block Selection Fee (ARUP test code 3002076) will be added to orders that utilize the first option. If multiple specimens are sent to ARUP without a request for pathologist block/slide selection or individual orders, they will be held until clarification is provided.

Stability

Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable

Reference Interval

By report

Interpretive Data

Refer to report.

This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.

Compliance Category

Analyte Specific Reagent (ASR)

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
3000703 Scoring Method 81304-8
3002939 Total Cell Count 78236-7
* 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