ARUP's Laboratory Test Directory

ERBB2 (HER-2/neu) (4B5) with Reflex to ERBB2 (HER-2/neu) Gene Amplification by FISH if 2+ : 2002217

Mnemonic: 4B5 2 IP

Methodology: Immunohistochemistry
Performed: Mon-Fri
Reported: 1-5 days
Reflexed to HER2FISH (0049218) if 2+, FISH assay will be performed and reported within 4-12 days, if no repeats are required.
Specimen Required: Collect: Tumor tissue

Specimen Preparation: Formalin fix and paraffin embed specimen. If sending precut slides, do not oven bake. Protect paraffin block and/or slides from excessive heat.

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

Remarks: Pathology report including tissue source and tumor origin must be submitted. IMMUNOHISTOCHEMISTRY ORDERING AND SUBMISSION DETAILS: Submit electronic request. If you do not have electronic ordering capability, use an ARUP Immunohistochemsitry form (form #32978) with an ARUP client number. For additional technical details, please contact ARUP Client Services at (800) 522-2787.

Unacceptable Conditions: Paraffin block with no tumor tissue remaining. Specimens fixed in formalin substitute.

Stability (collection to initiation of testing): Ambient: Indefinite; Refrigerated: Indefinite ; Frozen: Unacceptable
Reference Interval:
Effective August 15, 2011
 
Breast Tumors
Criteria for intensity of cell membrane staining with PATHWAY® HER-2/neu.
  Grade Interpretation Microscopic Finding
0 Negative No staining is observed in invasive tumor cells.
1+ Negative Weak, incomplete membrane staining in any proportion of invasive tumor cells, or weak, complete membrane staining in less than 10% of cells.
2+ Equivocal Complete membrane staining that is nonuniform or weak but with obvious circumferential distribution in at least 10% of cells, or intense complete membrane staining in 30% or less of tumor cells.
3+ Positive Uniform intense membrane staining of more than 30% of invasive tumor cells.
3+ reactions with PATHWAY® HER-2/neu are considered a positive result and indicative of a possible response to Herceptin therapy. 0 and 1+ reactions are considered negative and suggest a lack of response to Herceptin therapy. It is recommended that a 2+

Interpretive Data: Refer to report.
Note: If ERBB2 (HER-2/neu) (4B5) result is 2+, then ERBB2 (HER-2/neu) Gene Amplification by FISH will be added. Additional charges apply.
CPT Code(s): 88360; if reflexed, add 88368 x2
Cross References: 4B5 (ERBB2 (HER-2/neu) (4B5) with Reflex to ERBB2 (HER-2/neu) Gene Amplification by FISH if 2+) , 4B5 Reflex (ERBB2 (HER-2/neu) (4B5) with Reflex to ERBB2 (HER-2/neu) Gene Amplification by FISH if 2+)
 
 

 

 

 
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