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Updated: May 15, 2026

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Building Up a High-throughput Screening Platform to Assess the Heterogeneity of HER2 Gene Amplification in Breast Cancers
Published on: December 5, 2017
Is it necessary to evaluate nuclei in HER2 FISH evaluation?
Carlos López1, Barbara Tomás, Anna Korzynska
1Molecular Biology and Research Section, Hospital de Tortosa Verge de la Cinta, IISPV, URV, Tortosa, Spain. clopezp.ebre.ics@gencat.cat
American Journal of Clinical Pathology
|December 29, 2012
Summary
A new digital imaging method simplifies HER2 fluorescence in situ hybridization (FISH) testing for breast cancer. This enhanced HER2 FISH assessment is faster, easier, and more accurate than traditional evaluations.
Area of Science:
- Oncology
- Pathology
- Medical Imaging
Background:
- Accurate HER2 (Human Epidermal growth factor Receptor 2) gene amplification assessment is critical for breast cancer diagnosis and treatment selection.
- Traditional fluorescence in situ hybridization (FISH) evaluation can be complex and time-consuming.
Purpose of the Study:
- To introduce and validate a novel digital imaging (DI) method for evaluating HER2 status in breast cancer.
- To compare the accuracy and efficiency of the new DI-based HER2 FISH method against traditional FISH and immunohistochemistry (IHC).
Main Methods:
- Digital images of 423 invasive breast cancer stained sections were analyzed.
- HER2 and CEP17 (centromeric probe) signals were manually counted on separated stacked DIs.
- Results were compared with conventional FISH and IHC results.
Main Results:
- The new DI-based FISH method showed 96.93% agreement with traditional FISH, indicating "almost perfect" concordance (weighted k = 0.956).
- The method evaluated at least three times more nuclei compared to traditional approaches.
- Excellent agreement was also observed between the DI-based method and IHC scores.
Conclusions:
- The proposed enhanced DI method offers a more representative, easier, and faster assessment of HER2/CEP17 copy numbers in breast cancer biopsy specimens.
- This digital approach significantly improves HER2 FISH evaluation, potentially optimizing patient management.

