Her2 by FISH (Breast, Gastroesophageal cancer)

Alphabetical Test listing

Her2 by FISH (Breast, Gastroesophageal cancer)-4280J

  
Her2 by FISH (Breast, Gastroesophageal cancer)
  
4280J
  
LAB4280J - CYTOGENETICS MALIGNANT TISSUE STUDIES
  
CG HER12
  
HER2/neu
HER-2
C-ERB
Breast Cancer
Gastric Cancer

Esophageal cancer
chromosome 17
17q12
  

Detects amplification of the HER-2/neu gene associated with breast, gastric and esophageal cancers. HER2 amplification status determines whether a patient may benefit from HER2 molecular targeted therapy (Trastuzumab).

  
Involved malignant tissue (solid tumor or other)
  

Sterile container filled with sterile culture medium, sterile Hanks Balance Salt Solution (HBSS) or sterile saline.

  
5 mm (3)
  

Specimens should be immersed in sterile culture medium, sterile Hanks Balance Salt Solution (HBSS) or sterile saline within one (1) hour of the procedure

  

Sterile container filled with sterile culture medium, sterile Hanks Balance Salt Solution (HBSS) or sterile saline.

  
Tumor tissue FFPE block
Tumor tissue FFPE slides
  
  1. Fix the tissue in 10% neutral buffered formalin for 6 - 72 hours
  2. Prepare a formalin-fixed, paraffin-embedded (FFPE) tissue block

Either the entire block (an H&E will be cut and stained, and assessed by an HPA pathologist), or two (2) 5 micron cuts mounted on positively charged slides and one (1) H&E stained slide can be submitted for testing

  

Formalin-fixed paraffin-embedded (FFPE) tissue block or

5 micron cuts mounted on positively charged slides

  
  • Cytogenetics oncology requisition or pathology Add-on form
  

Ambient

  
Slides - 6 months
Blocks will be returned post reporting
  
  • Improper label (unlabeled or mislabeled)
  • Wrong container (anticoagulant or solution)
  • Improper storage
  • Leaking container
  • Slides broken beyond repair
  
AHL - Cytogenetics: X
  
As needed
  
3 - 5 days
  

Fluorescence in situ hybridization (FISH)

  

Breast: (5 result categories)

Group

Result

HER2/CEP 17 ratio

Mean HER2 signals/cell

Group 1

Positive

≥2.0

≥4.0

Group 5

Negative

<2.0

<4.0

Group 2

Indeterminate

≥2.0

<4.0

Group 3

Indeterminate

<2.0

≥6.0

Group 4

Indeterminate

<2.0

≥4.0 and <6.0

Note: When indeterminate scores occur, additional cell counts and IHC results are used to move this result to either a positive or negative result.

 

Gastric and esophageal:

Positive for amplification: HER2/CEP17 Ratio ≥2.0 or mean HER2 signals/cell ≥6.0

Negative: HER2/CEP17 Ratio <2.0 with a mean HER2 signals/cell <6.0

  
88377 – Quantitative Morphometric FISH

This test includes a charge for application of the 2 FISH probes and professional interpretation of the results. If no cells are available for analysis, no analysis charges will be incurred.
  
02/16/2011
  
03/11/2021
  
04/06/2021