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HER2/neu breast cancer by FISH

Test Code

FP HER2

Test 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.

Methodology

Fluorescence in situ Hybridization (FISH)

Turnaround Time

3-5 days

Specimen Requirements

10% neutral buffered formalin fixed paraffin embedded tissue.
5 mm^3 fresh tissue or 3.0 mL (min. 2.0 mL) FNA in MPLN RPMI media

Specimen Stability
Paraffin blocks stable at 18-25°C indefinitely
Fresh tissue or FNA stable at 2-8°C for 72 hours
Storage & Handling

Fresh tissue, FNA or paraffin embedded tissue, ship in a Styrofoam container with a cool/refrigerated pack (Do not allow cool pack to directly contact sample)

Causes for Rejection

Improper specimen labeling; Insufficient sample; Inadequate fixation and/or processing

Reference Range

Specimens with amplification of HER2 show a HER2/CEP17 ratio greater than or equal to 2.0. Non-amplified tissue shows a ratio of less than 2.0.

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, gastric and salivary gland carcinomas.

Clinical studies have shown that HER2/neu amplification as demonstrated by FISH is a statistically significant and independent predictor of tumor recurrence when compared to other commonly used prognostic markers such as tumor size, grade, patient age at diagnosis and hormone receptor status.

References

 

Trademarks
  • HERCEPTIN is a registered trademark of Genentech, Inc.