Download Leica Microsystems Releases Fully Automated HER2 FISH Test

Press Release
April 12, 2011
Leica Microsystems Releases Fully Automated HER2 FISH Test
Newcastle, United Kingdom. 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.”
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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.
Dr. Kirstin Henze
Tel.: +49(0)6441/29-2550
Fax: +49(0)6441/29-2527
[email protected]
Leica Microsystems GmbH
Ernst-Leitz-Straße 17-37
D – 35578 Wetzlar
www.leica-microsystems.com
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Press Release
The company 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.
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Intended Use
The Leica HER2 FISH System 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).
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Note
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® HER-2 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.
For further product or technical information, please contact:
Sarah Barnett
Theranostics Product Manager
Leica Biosystems Newcastle Ltd
Balliol Business Park West
Benton Lane
Newcastle Upon Tyne NE12 8EW
United Kingdom
Tel:
Fax:
+44 (0) 191 215 0567
+44 (0) 191 215 1152
[email protected]
95.10421 Rev A 04/11
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