ERBB2 (HER2/neu) Gene Amplification by FISH, Tissue
2008603
Ordering Recommendation
•Aids in prediction of response to trastuzumab (Herceptin) therapy in patients with breast or gastric cancer.
•Use to confirm equivocal HercepTest or 4B5 immunohistochemistry (IHC) result (2+).
Mnemonic
ERBB2 FISH
Methodology
Fluorescence in situ Hybridization
Performed
Varies
Reported
4-12 days  
New York DOH Approval Status
This test is New York DOH approved.
Submit With Order
Specimen Required
Patient Preparation
  
Collect
Tumor tissue.  
Specimen Preparation
Formalin fix (10 percent neutral buffered formalin) and paraffin embed tissue. Transport tissue block or 6 unstained 5 micron slides. (Min: 3 slides) Protect paraffin block from excessive heat. Transport block(s) and/or slide(s) in a tissue transport kit (ARUP supply #47808) available online through eSupply using ARUP Connect™ or contact ARUP Client Services at (800) 522-2787.  
Storage/Transport Temperature
Room temperature. Also acceptable: Refrigerated. Ship in cooled container during summer months.  
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.  
Remarks
Include surgical pathology report.  
Stability
Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable  
Reference Interval
   
Interpretive Data
Refer to report. ARUP uses the most recent ASCO/CAP interpretation criteria for evaluating ERBB2 (HER2) status.  
Note
 
CPT Code(s)
88367
Components
Component Test Code*Component Chart Name
0049241ERBB2 (HER2) by FISH
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
Aliases
  • c-erbB2 FISH
  • ERRB2 FISH
  • HER-2/neu FISH
  • Her-2/neu Gene Amplification or Overexpression
  • PathVysion FISH