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Leica Biosystems Leica HER2 FISH System - 30 Test Instructions for Use TA9217 EN-CE-Rev_D 08/04/2013
English
Intended Use
For in vitro diagnostic use
The Leica HER2 FISH System - 30 Test is designed to detect amplication of the HER2/neu
gene via uorescence in situ hybridization (FISH) in formalin-xed, parafn-embedded human
breast cancer tissue specimens. The Leica HER2 FISH System - 30 Test is indicated as an aid
in the assessment of patients for whom Herceptin
®*
(trastuzumab) treatment is being considered
(see Herceptin
package insert). The Leica HER2 FISH System - 30 Test is not intended for use
to screen for or diagnose breast cancer. All other available clinical information should also be
taken into consideration, such as tumor size, number of involved lymph nodes, and steroid
receptor status. No treatment decision for breast cancer patients should be based on HER2
gene amplication status alone.
Note: All of the patients in the Herceptin clinical trials were selected using an investigational
immunocytochemical Clinical Trial Assay (CTA). None of the patients in those trials were
selected using the Leica HER2 FISH System - 30 Test. The Leica HER2 FISH System - 30 Test
has been compared to the Abbott Molecular PathVysion
®*
HER-2 DNA Probe Kit assay on an
independent set of samples and found to provide acceptably concordant results, as indicated
in the Clinical Concordance Summary. The actual correlation of the results of the Leica HER2
FISH System - 30 Test to clinical outcome has not been established.
* Herceptin
®
is a trademark of Genentech, Inc. and F. Hoffmann-La Roche Ltd. PathVysion
®
is a trademark of Abbott Molecular
Inc. All Rights Reserved. Used under License.
Required training
Leica Biosystems will provide training in specimen preparation, assay procedure, and
interpretation of FISH testing of the HER2 gene for all users.
Summary and Explanation
Background
The HER2 gene, alternatively known as neu or c-erbB2, is located on the long arm of
chromosome 17 at position 17q11-12 (1). Both the HER2 gene and its 185 kD encoded protein
have been shown to play a major role in malignant transformation and tumor progression of
breast cancer (2).
HER2 functions as a prognostic marker, with gene amplication and protein over expression
being linked to an increased rate of disease recurrence and higher mortality. HER2
also functions as a predictive marker for selected systemic chemotherapy and targeted
treatments (3). Specically, amplication of the HER2 gene has been shown to be an indicator
of poor prognosis in node-positive breast cancer (4-8). Furthermore, one study indicates
the prognostic value of HER2 to be stronger among patients treated with chemotherapy (7).
However, in predicting disease-free and overall survival in individual patients, other established
prognostic factors such as tumor size, number of positive lymph nodes and steroid receptor
status must also be taken into consideration.
Overexpression of the HER2 oncoprotein, as a result of gene amplication found in breast cancer
cells, suggests HER2 as a target for an antibody-based therapy (3). Herceptin (trastuzumab),
a humanized monoclonal antibody (9) that binds with high afnity to the HER2 oncoprotein has
been shown to inhibit the proliferation of human tumor cells that overexpress HER2 oncoprotein
both in vitro and in vivo (10–12). Since the development of Herceptin, the detection of both
the HER2 gene and protein have become essential tools in the assessment of breast tumors,
directing both therapy selection and subsequent patient management (13,14).
In both interphase and metaphase cells derived from human breast carcinoma cell lines, FISH
has been used to show HER2 gene amplication (15-18). For quantication of HER2 gene
amplication, FISH assesses the level of HER2 gene amplication directly in the tumor cells.