ARUP's Laboratory Test Directory

ERBB2 (HER-2/neu) Gene Amplification by CISH : 2002443

Mnemonic: HER2CISH

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

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

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

Remarks: Only tissue that is clearly invasive breast carcinoma (established by histopathologic criteria) should be tested. Include surgical pathology report.

Unacceptable Conditions: Tissue not verified for the presence of invasive carcinoma. Carcinoma in situ. No tumor in tissue. Specimens fixed/processed in alternative fixatives (alcohol, Prefer®) or heavy metal fixatives (B-4 or B-5). Frozen specimens. Decalcified specimens.

Stability (collection to initiation of testing): Paraffin block: Ambient: Indefinitely; Refrigerated: Acceptable.

Reference Interval:
 
Result Definition
Non-amplification: 1-5 single dots in the majority (>50%) of carcinoma cells in the selected tissue area.
Amplification Greater than 5 dots in the majority (>50%) of carcinoma cells in the selected tissue area, or
Large clusters in the majority (>50%) of carcinoma cells in the selected tissue area, or
A mixture of multiple dots and large clusters in the majority (>50%) of carcinoma cells in the selected tissue area, or
Small clusters in the majority (>50%) of carcinoma cells in the selected tissue area.

Interpretive Data: Refer to report.
CPT Code(s): 88368
Cross References: HER2 (ERBB2 (HER-2/neu) Gene Amplification by CISH) , HER2 Chromegenic ISH (ERBB2 (HER-2/neu) Gene Amplification by CISH) , SPOT-Light® (ERBB2 (HER-2/neu) Gene Amplification by CISH)
 
 

 

 

 
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