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HER2 Gene Amplification FISH Assay

Reference Number: AA-00309

SECTION EIGHT

Dahl-Chase Diagnostic Services

MOLECULAR PATHOLOGY TESTING

FISH FOR HER2 GENE AMPLIFICATION

 

Clinical Significance:

 

HER2 gene amplification analysis is offered specifically as a prognostic molecular marker for invasive breast carcinoma and as an adjunctive test in the management of patients with advanced breast carcinoma for whom therapy with humanized monoclonal antibody is contemplated.  FISH also may be especially useful as a confirmatory assay for breast carcinoma cases for which a 2+ HER2 score has been identified previously by immunohistochemistry (IHC).

 

 

Specimen Requirements and Collection:

This FISH assay is performed using formalin-fixed paraffin-embedded tissue sections. 

 

Forms:

Molecular Pathology requisition form

 

Transport:

Send paraffin block containing breast carcinoma at room temperature 

 

Reference Range:

HER2/CEP17 ratio < 2.0 = HER2 gene amplification ABSENT

HER2 copy # 4-6 = EQUIVOCAL

Ratio > 2.0 and or copy # 4-6 = HER2 gene amplification PRESENT

 

 

CPT codes:

88377

 

 

 

Test reported:

Results are reported within 7-10 days