ARUP's Laboratory Test Directory

ERBB2 (HER-2/neu) Gene Amplification by FISH : 0049218

Mnemonic: HER2FISH

Methodology: Fluorescence in situ Hybridization
Performed: Varies
Reported: 4-12 days
Specimen Required: Collect: Tumor tissue.

Specimen Preparation: Formalin fix (10% neutral buffered formalin) and paraffin-embed tissue. Transport tissue block or 5 unstained 5 micron slides. (Min: 3 slides) Protect paraffin block from excessive heat.

Storage/Transport Temperature: Room temperature or refrigerated. Ship in cooled container during summer months.

Remarks: Include surgical pathology report.

Unacceptable Conditions: Frozen specimens. Specimens fixed or processed in alternative fixatives (alcohol, Prefer®) or heavy metal fixatives (B-4 or B-5). No tumor in tissue. Decalcified specimens.

Stability (collection to initiation of testing): Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable
Reference Interval:
 
Test Number Components Reference Interval
 HER-2/neu by FISH (Manual) Nonamplified: LSIHER-2/neu: CEP17 Less than or equal to 1.7
Equivocal: LSIHER-2/neu: CEP17 is 1.8 to 2.2
Amplified: LSIHER-2/neu: CEP17 2.3 or greater
 HER-2/neu:CEP®17 By report
 CEP17 per Cells Counted Ratio By report
 Percent of Amplified Invasive Tumor Effective August 15, 2011

Genetic heterogeneity (GH) exists when there are more than 5 percent but less than 50 percent of infiltrating tumor cells with a ratio higher than 2.2.

Interpretive Data: Refer to report.
CPT Code(s): 88368 x2
Cross References: Her-2/neu Gene Amplification or Overexpression (ERBB2 (HER-2/neu) Gene Amplification by FISH) , HER2 (ERBB2 (HER-2/neu) Gene Amplification by FISH)
 
 

 

 

 
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