Related Experiment Video
Updated: Jul 11, 2026

Robust Detection of Gene Amplification in Formalin-Fixed Paraffin-Embedded Samples by Fluorescence In Situ Hybridization
Published on: July 12, 2024
Evaluation of FISH image analysis system on assessing HER2 amplification in breast carcinoma cases
Zenonas Theodosiou1, Ioannis N Kasampalidis, Georgia Karayannopoulou
1Department of Informatics, Aristotle University of Thessaloniki, Box 451, 54124 Thessaloniki, Greece.
Abstract:
HER2-positive breast cancer is characterized by aggressive growth and poor prognosis. Women with metastatic breast cancer with over-expression of HER2 protein or excessive presence of HER2 gene copies are potential candidates for Herceptin (Trastuzumab) targeted treatment that binds to HER2 receptors on tumor cells and inhibits tumor cell growth. Fluorescence in situ hybridization (FISH) is one of the most widely used methods to determine HER2 status. Typically, evaluation of FISH images involves manual counting of FISH signals in multiple images, a time consuming and error prone procedure. Recently, we developed novel software for the automated evaluation of FISH images and, in this study, we present the first testing of this software on images from two separate research clinics. To our knowledge, this is the first concurrent evaluation of any FISH image analysis software in two different clinics. The evaluation shows that the developed FISH image analysis software can accelerate evaluation of HER2 status in most breast cancer cases.
Insights
Automated software for HER2 FISH image analysis accelerates HER2 status evaluation in breast cancer. This novel tool reduces time and errors compared to manual counting, improving efficiency for targeted Herceptin treatment decisions.
Area of Science:
- Oncology
- Medical Imaging
- Biotechnology
Background:
- HER2-positive breast cancer exhibits aggressive behavior and poor prognosis.
- Targeted therapy with Herceptin (Trastuzumab) is effective for metastatic breast cancer overexpressing HER2.
- Fluorescence in situ hybridization (FISH) is crucial for determining HER2 status, but manual image evaluation is time-consuming and error-prone.
Purpose of the Study:
- To evaluate a novel software for automated analysis of FISH images for HER2 status determination.
- To assess the software's performance in a multi-clinic setting for the first time.
Main Methods:
- Development of novel software for automated FISH image analysis.
- Testing the software on FISH images from two independent research clinics.
- Comparison of automated evaluation with traditional manual counting methods (implied).
Main Results:
- The developed FISH image analysis software demonstrated the ability to accelerate HER2 status evaluation.
- Concurrent evaluation across two clinics confirmed the software's applicability in different settings.
- The software shows potential to improve efficiency in diagnosing HER2-positive breast cancer.
Conclusions:
- Automated FISH image analysis software offers a significant improvement over manual methods for HER2 status evaluation.
- This technology has the potential to expedite diagnosis and treatment decisions for HER2-positive breast cancer patients.
- The software's validation in multiple clinics suggests its broad utility in clinical practice.

