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ERBB2 (HER2/neu) Gene Amplification by FISH with Reflex, Tissue
2008603
Ordering Recommendation

Aid in prediction of response to HER2-directed therapy in patients with breast or gastric cancer.

Mnemonic
ERBB2 FISH
Methodology
Fluorescence in situ Hybridization
Performed
Monday-Friday
Reported
3-9 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. Fixative duration: 6-72 hours.  Protect paraffin block from excessive heat. Transport block or 7 unstained (4 micron thick sections) positively charged slides in a tissue transport kit (ARUP supply #47808) available online through eSupply using ARUP Connect™ or contact ARUP Client Services at (800) 522-2787 (kit recommended but not necessary). (Min 4 slides) 
Storage/Transport Temperature
Room temperature. Also acceptable: Refrigerated. Ship in cooled container during summer months. 
Unacceptable Conditions
Specimens fixed or processed in alternative fixatives (alcohol, Prefer) or heavy metal fixatives (B-4 or B-5). No tumor in tissue. Decalcified specimens.  Tissue fixed for less than 6 hours or greater than 72 hours. 
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
Breast tissue results of FISH group 2, 3, or 4 will be reflexed to ERBB2 (HER2/neu) (HercepTest) with Interpretation by Immunohistochemistry, Tissue (ARUP test code 0049174). Additional charges apply. Gastric and other non-breast tissue results of Equivocal will be reflexed to an alternate probe in an effort to resolve amplification status. Additional charges apply.
Hotline History
View Hotline History
CPT Code(s)
88377, if reflexed add 88360 or 88377
Components
Component Test Code*Component Chart NameLOINC
0049241ERBB2 (HER2) by FISH42783-1
* 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
  • CEP17
  • ERRB2 FISH
  • HER-2/neu FISH
  • Her-2/neu Gene Amplification or Overexpression
  • HER2/CEP17 Ratio
  • PathVysion FISH