Leica TA9217 사용자 설명서

  

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Leica Biosystems  Leica HER2 FISH System - 30 Test Instructions for Use TA9217 EN-CE-Rev_D 08/04/2013

For in vitro diagnostic use

The Leica HER2 FISH System - 30 Test is designed to detect amplification of the HER2/neu 

gene via fluorescence in situ hybridization (FISH) in formalin-fixed, paraffin-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 amplification 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.

Leica  Biosystems  will  provide  training  in  specimen  preparation,  assay  procedure,  and 

interpretation of FISH testing of the HER2 gene for all users.

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 amplification 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). Specifically, amplification 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 amplification 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 affinity 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  amplification  (15-18).  For  quantification  of  HER2  gene 

amplification, FISH assesses the level of HER2 gene amplification directly in the tumor cells.