ERBB2 (HER2/neu) Gene Amplification by PCR
0049390
 
Ordering Recommendation
Resolves discrepancies between ERBB2 FISH, dual-ISH and immunohistochemistry (IHC) results.
Mnemonic
HER2 PCR
Methodology
Polymerase Chain Reaction
Performed
Varies
Reported
7-12 days
New York DOH Approval Status
This test is New York DOH approved.
Specimen Required
Patient Preparation
 
Collect
Tumor tissue.  
Specimen Preparation
Formalin fix (10 percent neutral buffered formalin) and paraffin embed tissue. Protect from excessive heat. Transport tissue block or 4 unstained (Min: 2 slides) Transport block 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 or refrigerated. Ship in cooled container during summer months.  
Unacceptable Conditions
Specimens fixed/processed in alternative fixatives (alcohol, Prefer®) or heavy metal fixatives (B-4 or B-5). Decalcified specimens.  
Remarks
Include surgical pathology report. Tissue block will be returned after testing.  
Stability
Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable  
Reference Interval
By report
Interpretive Data
Refer to report.

This test is performed pursuant to an agreement with Roche Molecular Systems, Inc.

See Compliance Statement B: www.aruplab.com/CS
Note
CPT Code(s)
88381; 81479
Components
Component Test Code*Component Chart Name
0049199Client Case or Ref #
0049207Source:
0049391ERBB2 Amplification Results
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, contact interface support at interface.support@aruplab.com.
Cross References
  • HER2
  • Herceptin therapy response