EGFR Gene Amplification by FISH
Also known as: EGFR_FISH
Use
This test aids in prognostication and therapeutic decisions for neoplasms where EGFR amplification has been demonstrated. It is not recommended for EGFR mutation detection in non-small cell lung carcinoma (NSCLC). EGFR gene amplification is often observed in various tumor types. In gliomas, its amplification is associated with higher-grade tumors, especially primary glioblastomas, correlating with worse outcomes in anaplastic astrocytoma. It may also be used as a prognostic marker or to predict tumor response to targeted therapy in other tumor types.
Special Instructions
Include the surgical pathology report. If multiple specimens (blocks or slides) are sent to ARUP, they must be accompanied by an order comment indicating that the ARUP pathologist should choose the most appropriate specimen for testing (e.g., 'Choose best block'), or individual orders for each sample must be submitted. A Pathologist Block Selection Fee (ARUP test code 3002076) will be added to orders that utilize the first option. Unacceptable specimens including paraffin blocks with no tumor tissue remaining.
Limitations
The test has not been cleared or approved by the US Food and Drug Administration. It is performed in a CLIA certified laboratory and is intended for clinical purposes. The test is performed on a section from a paraffin-embedded tissue block with fluorescent probes targeting the EGFR gene and chromosome 7 centromere (CEP7). It may not detect all forms of heterogeneity in tumors and does not identify EGFR mutations.
New York Approved
Methodology
Chromosomal / Cytogenetics (FISH)
Biomarkers
LOINC Codes
- 81304-8
- 78236-7
Result Turnaround Time
3-7 days
Related Documents
For more information, please review the documents below
Specimen
Tumor Tissue (FFPE)
Volume
Not provided
Minimum Volume
2 slides
Container
Paraffin block or transport kit
Collection Instructions
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.
Storage Instructions
Room temperature or refrigerated during summer months.
Causes for Rejection
Paraffin block with no tumor tissue, specimens fixed in any fixative other than 10 percent neutral buffered formalin, decalcified specimens.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | Indefinitely |
| Refrigerated | Indefinitely |
| Frozen | Unacceptable |