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Updated: May 28, 2026
Protocol for HER2 FISH Using a Non-cross-linking, Formalin-free Tissue Fixative to Combine Advantages of Cryo-preservation and Formalin Fixation
Published on: December 25, 2017
Determination of HER2 gene status by fully automated fluorescence microscopy
Michael W Kilpatrick1, Christine E Sheehan, William A Marganski
1Department of Pathology and Laboratory Medicine, Albany Medical College, Albany, New York 12208, USA.
Objective:
To examine fluorescence in situ hybridization (FISH) in HER2 amplification in response rates to trastuzumab therapy and both taxane and anthracycline-based chemotherapy regimens.
Study Design:
A total of 400 tumor sections were analyzed over an 8-month period. The sections were hybridized with probes for the HER2 gene and chromosome 17 centromere using standard FISH methods and analyzed on an automated fluorescence microscopy system.
Results:
Reliable and valid methods for identification of the patients that will respond to treatment with trastuzumab are needed in order to achieve maximum therapy efficacy and maintain cost efficiency. FISH-based analysis is potentially an objective and reproducible approach to determination of HER2 gene status; however, manual FISH counting is a laborious task and subject to inter and intraobserver variability.
Conclusion:
The system described in this paper is a valuable tool in providing a consistent approach to the interpretation of breast tumor tissue analyzed by FISH analysis. In addition to consistency, an automated system provides a record of the images produced that can be of immediate benefit in multiple review of a difficult or equivocal case and long-term benefit in terms of providing a permanent case record.
Insights
Automated fluorescence in situ hybridization (FISH) provides a consistent method for HER2 gene analysis. This improves patient selection for trastuzumab therapy and chemotherapy, enhancing treatment efficacy and cost-efficiency.
Area of Science:
- Oncology
- Biotechnology
- Medical Diagnostics
Background:
- Accurate HER2 gene amplification status is crucial for predicting response to trastuzumab therapy in breast cancer.
- Manual fluorescence in situ hybridization (FISH) for HER2 analysis is labor-intensive and prone to variability.
Purpose of the Study:
- To evaluate an automated fluorescence in situ hybridization (FISH) system for HER2 amplification analysis.
- To assess the utility of FISH in predicting response to trastuzumab and chemotherapy regimens.
Main Methods:
- Analyzed 400 tumor sections using standard FISH methods with probes for the HER2 gene and chromosome 17.
- Employed an automated fluorescence microscopy system for FISH analysis.
Main Results:
- Manual FISH counting presents challenges with inter- and intraobserver variability.
- Automated FISH analysis offers a reproducible and objective method for determining HER2 gene status.
Conclusions:
- The automated FISH system ensures consistent interpretation of breast tumor tissue.
- This automated approach provides a permanent digital record, aiding in case review and long-term data management.
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