EGFR Gene Amplification by FISH
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).
New York DOH Approval Status
Specimen Required
Tumor tissue.
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)
Room temperature. Also acceptable: Refrigerated. Ship in cooled container during summer months.
Paraffin block with no tumor tissue remaining. Specimens fixed in any fixative other than 10 percent neutral buffered formalin. Decalcified specimens.
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.
Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable
Methodology
Fluorescence in situ Hybridization (FISH)
Performed
Mon-Fri
Reported
3-7 days
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.
Analyte Specific Reagent (ASR)
Note
Hotline History
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 |
Aliases
- EGFR amplification by FISH
- EGFR FISH
- EGFR; EGFR (Her-1)
- Epidermal Growth Factor Receptor
- erbB-1
- Her-1
- HER1/EGFR