HER2 Gene Status Accurately Assessed in Breast Cancer Tissue

A fully automated system easily and accurately assesses HER2 gene status in breast cancer tissue.

The system uses an optimized ready-to-use HER2 fluorescence in situ hybridization (FISH) reagent kit with a BOND protocol to produce consistent, high quality stained slides. The system enhances the laboratory workflow, increasing efficiency, and enabling the laboratory to provide a responsive service to their clinicians and clients.


Designed by Leica Microsystems (Buffalo Grove, IL, USA) the HER FISH system detects amplification of the HER2/neu gene via FISH in formalin-fixed, paraffin-embedded (FFPE) human breast cancer-tissue specimens. The Leica HER2 FISH System is indicated as an aid in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered.

Designed for easy and accurate assessment of HER2 gene status in breast cancer tissue, the Leica HER2 FISH System combines the use of the gold standard PathVysion HER2 FISH probes, supplied by Abbott Molecular Inc. (Des Plaines, IL, USA) with Leica's industry-leading BOND automated platform, delivering accurate results for diagnostic confidence.

The Leica HER2 FISH System was compared to the Abbott Molecular PathVysion HER2 DNA probe kit assay on an independent set of samples and found to provide acceptably concordant results. The actual correlation of the results of the Leica HER2 FISH System to clinical outcome has not been established.

Related Links:
Leica Microsystems
Abbott Molecular Inc.