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HER2/neu by FISH

PathVysion® HER-2DNAProbeKit

F HER2

Test Synonym:

HER2-neu, c-erbB2, (17p11.2) gene amplification

CPT Code:

88367 x2 - Morphometric analysis, in situ hybridization, each probe; using computer assisted technology

or
88368x2 - Morphometric analysis, in situ hybridization, each probe; manual

Turnaround Time:

3 days

Methodology:

Fluorescence in situ hybridization (FISH)

Specimen Requirements:

10% neutral buffered formalin fixed paraffin embedded tissue

Causes for Rejection:

Improper specimen labeling; insufficient sample; inadequate fixation and/or processing

Specimen Stability:

Paraffin block stable at 18-25°C Indefinately

Storage and Handling:

Ship at Ambient. In summer ship with an ice pack (do not allow ice pack to directly contact sample)

Reference Range:

Specimens with amplification of HER-2 show a HER-2/CEP17 ratio greater than or equal to 2.0.

Non-amplified tissue shows a ratio of less than 2.0.

Indication:

Her-2/neu, also known as erbB2 or HER-2, plays a key role in the regulation of cell growth. HER-2 is over-expressed through gene amplification in 25-30% of breast cancer patients. Over-expression of HER-2 has also been observed in ovarian, endometrial, gastric, and salivary gland carcinomas.

Clinical studies have shown that HER-2/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.

Results of the FDA approved HER2/neu PathVysion® kit are intended for use as an adjunct to existing clinical and pathologic information currently used as prognostic factors in stage II, node-positive breast cancer patients. The HER2/neu test is also an aid to predict disease-free and overall survival in patients with stage II, node positive breast cancer treated with adjuvant cyclophosphamide, doxorubicin, and 5-fluorouracil (CAF) chemotherapy.
The PathVysion Kit is indicated as an aid in the assessment of patients for whom HERCEPTIN® (Trastuzumab) treatment is being considered.

References:

  1. 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. http://jco.ascopubs.org/cgi/content/full/25/1/118
  2. 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
  3. Press et al. (1997). HER-2/neu gene amplification characterized by fluorescence in situ hybridization: Poor prognosis in node-negative breast carcinomas. J Clin Oncol 15:2894
  4. Pauletti et al. (1996). Detection and quantitation of HER-2/neu gene amplification in human breast cancer archival material using fluorescence in situ hybridization. Oncogene 13:63

Trademarks:

PathVysion is a registered trademark of Abbott Molecular Inc

HERCEPTIN is a registered trademark of Genentech, Inc.