Test Name
HER2/neu breast cancer, paraffin
Test Code
FP HER2
Synonyms
HER2/neu, CEP 17,17q11.2q12 amplification
Associations
HER2-positive tumors have shown to benefit from Herceptin treatment. Current recommendations for HER2 testing include using FISH as a follow up for all IHC 2+ cases.
CPT Codes
88377
Turnaround Time
5
Specimen Requirements
FFPE tissue is acceptable for FISH analysis. Preferred fixative is 10% neutral buffered formalin. Tissues preserved in B5 fixative or decalcified are usually not suitable for FISH. Tumor sections cut 3-5 µm thick and mounted on positively charged organosilane coated (silanized) slides work well. Request several unstained sections (two for each probe) and one H&E stained slide
Specimen Stability
Stable indefinitely when stored at 20°C to 25°C
Storage & Handling
4°C to 25°C during transit, but specimens may be transported on refrigerated gel packs. Do not allow the gel pack to come in contact with the specimen. Do not freeze. Extreme temperatures should be avoided.
Causes for Rejections
Improper fixative; Tissue not fixed; Insufficient tissue; Specimen exposed to extreme temperature
Description
Her2/neu, also known as erbB2 or HER2, plays a key role in the regulation of cell growth. HER2 is over expressed through gene amplification in 25-30% of breast cancer patients. Over expression of HER2 has also been observed in ovarian, endometrial, gastri
References
- Wolff et al. (2007). American Society of Clinical Oncology/College of American Pathologists Guideline Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer. J Clin Oncol. 25:118-145.
- Pauletti et al. (2000). Assessment of methods for tissue-based detection of the HER-2/neu alteration in human breast cancer. J Clin Oncol. 18:3651.
