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).

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

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.

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

• Improper label (unlabeled or mislabeled)
• Wrong container (anticoagulant or solution)
• Improper storage
• Leaking container
• Slides broken beyond repair

Fluorescence in situ hybridization (FISH)

Breast: (5 result categories)

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