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Fully automated HER2 fluorescence in situ hybridisation testing

The latest developments in automation will come to the aid of histopathology departments that offer fluorescence in situ hybridisation testing for HER2 gene amplification. Human epidermal growth factor 2 (HER2) is a transmembrane receptor with tyrosine kinase activity that exist in low levels on normal breast epithelial cells but is over-expressed in 20–30% of patients with invasive breast cancer. This is caused by amplification of the HER2 gene on chromosome 17, and there is a very good correlation between HER2 receptor protein over-expression and HER2 gene amplification in breast cancer.

Over the past two decades it has been shown that HER2 is an adverse prognostic indicator, associated with a particularly aggressive form of breast cancer. The development of the drug trastuzumab (Herceptin), which targets the HER2 receptor, reducing aberrant cell signalling and the characteristics associated with the malignant state in these aggressive cancers, has offered a major breakthrough in treatment. However, identifying those patients who will benefit from Herceptin treatment relies heavily on the application of immunohistochemistry (IHC) and fluorescence in situ hybridisation (FISH) methods, and the latter will benefit from the latest developments in automation.
 
Automated gene testing
Leica Microsystems has announced the European release of the fully automated Leica HER2 FISH system for the Leica BOND advanced staining system. 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, with Leica’s industry-leading BOND automated platform, delivering accurate results for diagnostic confidence.

Automation of labour-intensive FISH techniques reduces process variation while offering walkaway convenience. Samples can be processed continuously, eliminating the need to batch cases, offering fast turnaround times, saving valuable hands-on time and allowing rapid reporting. This fully automated system uses an optimised ready-to-use Leica HER2 FISH reagent kit with a robust 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 clinicians and patients.

Arnd Kaldowski, president of Leica Biosystems, commented: “Our HER2 FISH test provides improved workflow for the laboratory while maintaining the highest standards associated with HER2 FISH testing. Leica BOND users are now able to perform a full compliment of IHC and ISH breast testing on our BOND system, offered through our Theranostics and Novocastra product lines, delivering the diagnostic confidence needed for effective patient management.”

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