Indications For BREAST CANCER: HER-2 FISH (PathVysion™)

This blood test allows identification of HER-2 over expression by immunohistochemistry in conjunction with gene amplification detected by FISH is associated with a comprehensive positive response to the humanized, monoclonal antibody Herceptin® in patients that have failed standard chemotherapy treatment.  The detection of HER-2/neu gene amplification by FISH analysis is linked with rapid cancer cell proliferation, decreased disease-free survival and poor overall survival in both node-negative and node-positive ductal breast cancers.  In patients with advanced breast carcinoma, HER-2 amplification predicts responsiveness to transtuzumab (Herceptin®) therapy and poor response to standard chemotherapy. 

Collection Procedure
Fixed Paraffin Block with Corresponding H&E:

  • Tissue should be well fixed and well processed.  Formalin fixation preferred unless otherwise indicated.  If alternative fixative is used, it should be noted on requisition
  • 0.2cm x 0.2cm x .2cm tissue
  • Store specimen at room temperature (>16°)

Specimen Requirements

Unstained Slides:

  • Send all slides within 6 weeks of cutting
  • Minimum of 4 slides for FISH testing
  • Pre-cut slides from paraffin block in 5 micron sections and mounted on poly-l-lysine coated or plus (+) slides
  • IHC+ region indicated and  IHC score
  • Air dry.  Do not oven dry
  • Store specimens at room temperature (>16°)

Specimen Container

Send slides in protective case to prevent damage. 


Laboratory testing for HER-2/neu gene amplification involves Microscopic analysis, digital image capture

Causes for Rejection

Inappropriate processing of tissue or IHC negative result 


Room temperature 

Turnaround Time

2-3 days