ERBB2 (HER2/neu) Gene Amplification by Dual in-situ Hybridization
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+).
•Preferred alternative to FISH.
Dual in situ Hybridization
3-5 days  
New York DOH Approval Status
This test is New York DOH approved.
Submit With Order
Specimen Required
Patient Preparation
Tumor tissue.  
Specimen Preparation
Formalin fix (10 percent neutral buffered formalin) specimen no later than 30 minutes after removal from patient and paraffin-embed tissue. Fixative duration: 8-48 hours. Transport tissue block or 5 unstained (3- to 5-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)522-5257. (Min: 3 slides) If sending precut slides, do not oven bake.  
Storage/Transport Temperature
Room temperature. Also acceptable: Refrigerated. Ship in cooled container during summer months.  
Unacceptable Conditions
Paraffin block with no tumor tissue remaining. Specimens with fixation delayed for more than 30 minutes. Specimens fixed in any other fixative other than 10 percent neutral buffered formalin. Specimens fixed in heavy metal fixatives (B-4 or B-5). Tissue fixed for less than 8 hours or greater than 48 hours. Cytology specimens fixed in alcohol. Frozen specimens. Decalcified specimens.  
Pathology report including tissue source and tumor origin must be submitted. Document time from tissue acquisition to fixation and fixation duration on requisition or enter at time of order.  
Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable  
Reference Interval
Interpretive Data
Refer to report  
CPT Code(s)
Component Test Code*Component Chart NameLOINC
0049219HER2/ neu:CEP 17 Ratio49683-6
0049243HER2 - Number of Tumor Cells Counted19076-9
0049261HER2 - Number of Observers19099-1
2005262Percent of Amplified Invasive Tumor 
2005263Her2 Genetic Heterogeneity 
2007411ERBB2 by DUAL ISH Result 
2007412CEP17 signals per cell 
2007413ERBB2 (HER2) signals per cell 
2007417ERBB2 by Dual ISH Comments 
* 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.
  • c-erbB2 Dual ISH
  • ERBB2 Dual ISH
  • HER-2/neu Dual ISH
  • INFORM Dual In-situ Hybridization Probe