ARUP's Laboratory Test Directory

HER-2/neu by FISH (PathVysion™ HER-2) : 0049218

Mnemonic: HER2FISH

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

Transport:  Paraffin-embedded, formalin-fixed tissue block at 20-25°C. 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:  Paraffin block:  Ambient: Indefinitely; Refrigerated: Acceptable; 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

Interpretive Data: The determination of the presence of amplification for the HER-2/neu oncogene is based on the counting of immunofluorescent signals for HERP-2/neu and CEP®17 contained within the interphase nuclei of invasive carcinoma cells.

Manufacturer's guidelines for nonamplified and amplified cells are based on enumeration of 20 interphase nuclei from tumor cells per target reported as the ratio of average HER-2/neu copy number to that of CEP®17.

This test is FDA approved for formalin fixed tissue only.

ARUP Laboratories uses the Vysis® PathVysion™ HER2 DNA Probe kit which is FDA approved for the detection of the HER2 gene via fluorescence in situ hybridization (FISH).
CPT Code(s): 88368 x2
 
 

 

 

 
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