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Updated: Feb 6, 2026
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Cutting Procedures, Tensile Testing, and Ageing of Flexible Unidirectional Composite Laminates
Published on: April 27, 2019
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The FlexISH assay brings flexibility to cytogenetic HER2 testing
Gero Brockhoff1, Maria Bock2, Florian Zeman3
1Department of Gynaecology and Obstetrics, University of Regensburg, Regensburg, Germany. gero.brockhoff@ukr.de.
Histopathology
|March 25, 2016
Summary
This study validates a new dual-colour FISH assay for human epidermal growth factor receptor 2 (HER2) gene testing in breast cancer. The assay offers flexible overnight or rapid (<2 h) hybridization with excellent accuracy, comparable to established methods.
Area of Science:
- Oncology
- Molecular Diagnostics
- Genetics
Background:
- Fluorescence in-situ hybridization (FISH) is critical for human epidermal growth factor receptor 2 (HER2) gene testing in invasive breast cancer.
- Accurate HER2 testing significantly impacts patient diagnosis and treatment.
- Current FISH assays aim for rapid completion of diagnostic procedures.
Purpose of the Study:
- To evaluate the performance and utility of a novel dual-colour HER2/cen17 FISH assay.
- To assess the assay's flexibility for both rapid (<2 h) and overnight hybridization.
- To compare the novel assay with established HER2 FISH methods.
Main Methods:
- Quantitative and qualitative comparison of the FlexISH SPEC ERBB2/CEN 17 kit with established HER2 FISH assays.
- Testing on 90 malignant and 19 benign paraffin-embedded breast tissue specimens.
- Utilizing both short (2 h) and long (overnight) hybridization periods.
Main Results:
- Excellent correlation between FISH results from FlexISH, ZytoLight, and PathVysion probes.
- Consistent performance across short-run and long-run applications of FlexISH.
- High signal counts, signal-to-noise ratio, brightness, and distinctness of HER2 and cen17 signals.
Conclusions:
- The FlexISH probe kit demonstrates excellent accordance with other commercial FISH kits in all tested aspects.
- FlexISH offers high flexibility for laboratory management, allowing for rapid (<4.5 h) or standard overnight workflows.
- The assay provides reliable HER2 findings without compromising performance, specimen quality, or diagnostic outcomes.
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