HER2/neu PathVysion®
Test Code
F HER2
Test Synonyms
HER2/neu, CEP 17,17q11.2q12 amplification
Associations
Breast cancer
Methodology
Fluorescence in situ Hybridization (FISH)
CPT Codes
-
88367 x2 - Morphometric analysis, in situ hybridization, each probe, using computer assisted technology
88368 x2 - Morphometric analysis, in situ hybridization, each probe, manual
Turnaround Time
3 days
Specimen Requirements
Fix specimen in 10% neutral buffered formalin for at least 6 hours and no longer than 48 hours.
Specimen Stability
Paraffin block stable at 18-25°C indefinately
Storage & Handling
Ship at ambient. In summer, ship with an ice pack. (Do not allow ice 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.
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.
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.
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
- 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.
Trademarks
- PathVysion is a registered trademark of Abbott Molecular, Inc.
- HERCEPTIN is a registered trademark of Genentech, Inc.
