EGFR Gene Amplification by FISH

Also known as: EGFR_FISH

Clinical Use

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

Not provided.

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.

Test Details

New York Approved

Methodology

Chromosomal / Cytogenetics (FISH)

Biomarkers

No genes

Gene

EGFR/CEP7 FISH Ratio

Copy Number Alteration • Categorical (e.g., Positive / Negative / Indeterminate)

LOINC Codes

Result Codes

81304-8 - Struct var analysis method
78236-7 - Cells.IGH rear/Cells cnt NFr Bld/T FISH

Result Turnaround Time

3-7 days

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.