ARUP's Laboratory Test Directory

HER-2/neu by CISH (SPOT-Light®) : 2002443

Mnemonic: HER2CISH

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

Storage/Transport Temperature: Paraffin-embedded, formalin-fixed tissue block, or 6 unstained, positively charged slides at 20-25°C. (Min: 5 slides) Protect paraffin block from excessive heat. Ship in cooled container during summer months. Include surgical pathology report.

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

Unacceptable Conditions: Tissue not verified for the presence of invasive carcinoma. Carcinoma in situ is NOT acceptable. Specimens fixed in fixatives other than formalin.

Stability (collection to initiation of testing): Paraffin block: Ambient: Indefinitely; Refrigerated: Acceptable; Frozen: Unacceptable
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: This test is FDA approved for formalin-fixed tissue only.

ARUP Laboratories uses the SPOT-Light® HER-2 CISH Kit which is FDA approved for the detection of the HER-2 gene via chromogenic in situ hybridization (CISH).

Refer to the Breast Cancer Management Assays or Tumor Markers topic at arupconsult.com.
CPT Code(s): 88368
 
 

 

 

 
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