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 Inc, with Leica’s industry-leading BOND automated platform, delivering accurate results for diagnostic confidence.
Automation of labor intensive FISH techniques reduces process variation while offering walk-away 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 of patient results. This fully automated system uses an optimized 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 their clinicians and clients.
Arnd Kaldowski, President of Leica Biosystems, commented: “Our HER2 FISH test provides improved workflow for the laboratory while maintaining the highest standard 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.”
Leica Microsystems is a world leader in microscopes and scientific instruments. Founded as a family business in the nineteenth century, the company’s history was marked by unparalleled innovation on its way to becoming a global enterprise. Its historically close cooperation with the scientific community is the key to Leica Microsystems’ tradition of innovation, which draws on users’ ideas and creates solutions tailored to their requirements. At the global level, Leica Microsystems is organized in four divisions, all of which are among the leaders in their respective fields: the Life Science Division, Industry Division, Biosystems Division and Medical Division.
Leica Microsystems' Biosystems Division, also known as Leica Biosystems, offers histopathology laboratories the most extensive product range with appropriate products for each work step in histology and for a high level of productivity in the working processes of the entire laboratory.
Leica Microsystems is represented in over 100 countries with 12 manufacturing facilities in 7 countries, sales and service organizations in 19 countries and an international network of dealers. The company is headquartered in Wetzlar, Germany.
The Leica HER2 FISH System (Leica-Microsystems.com) is designed to detect amplification of the HER2/neu gene via fluorescence in situ hybridization (FISH) in formalin-fixed, paraffin-embedded 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 (see Herceptin package insert).
The Leica HER2 FISH System is not intended for use to screen for or diagnose breast cancer. All other available clinical information should also be taken into consideration, such as tumor size, number of involved lymph nodes, and steroid receptor status. No treatment decision for breast cancer patients should be based on HER2 gene amplification status alone.
Note: All of the patients in the Herceptin clinical trials were selected using an investigational immunocytochemical Clinical Trial Assay (CTA). None of the patients in those trials were selected using the Leica HER2 FISH System. The Leica HER2 FISH System has been 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.
*PathVysion® is a trademark of Abbott Molecular Inc. All Rights Reserved. Used under License.
**Herceptin® is a trademark of Genentech, Inc. and F. Hoffmann-La Roche Ltd.