Leica Microsystems Releases a Complete Solution for HER2 IHC Testing Into the Europe, Middle East, Africa and Asia Pacific Regions

02 Jun 2008 - Newcastle, United Kingdom / Melbourne, Australia

Breast Carcinoma Tissue (3+ HER2 expression) Optimally stained using the Oracle HER2 Bond IHC System (TA9145)
Leica Microsystems is pleased to announce the release of an important new theranostic product: the Oracle™ HER2 Bond™ IHC System. This fully automated system runs on Leica Microsystems’ Bond automated staining platform and includes components for 60 tests. The Oracle system joins Leica Microsystems’ broad range of histology products and demonstrates the breadth of Leica’s theranostic capabilities. With the fully integrated Oracle HER2 Bond IHC System, laboratories now have a complete HER2 IHC solution.

The Oracle HER2 Bond IHC System is a semi-quantitative immunohistochemical assay to determine HER2 (Human Epidermal Growth Factor Receptor 2) oncoprotein status in human breast cancer tissue processed for histological evaluation. The Oracle HER2 Bond IHC System is indicated as an aid in the assessment of patients for whom Herceptin® (trastuzumab) treatment is being considered.

Oracle is the only fully automated system where the components are created specifically to work
together. The ready-to-use antibody (reformulated Clone CB11), Compact Polymer™ detection system and control slides were developed in-house using Novocastra™ science and the entire system is optimized specifically for the Leica Bond IHC and ISH stainer. This unmatched level of integration creates a robust system that can be relied on to produce consistent high quality results.

To further increase assay validation accuracy, each Oracle HER2 Bond IHC System includes control slides that demonstrate HER2 oncoprotein expression at four levels (0, 1+, 2+ and 3+). The cell lines were developed in-house using fully characterized formalin-fixed, paraffin embedded human breast cancer cells.

The Oracle HER2 Bond IHC System demonstrates Leica Microsystems’ expanding capabilities in the
emerging field of theranostics where prognostic testing is closely tied to personalized drug therapy. For breast cancer patients, HER2 status is used as a prognostic aid that can help select those who may benefit from Herceptin® drug treatment. With the ability to create completely integrated and fully automated systems, Leica Microsystems will play an important role in developing cutting-edge cancer diagnostics.

About Us
The Oracle HER2 Bond IHC System perfectly complements other fully automated histology products from the Biosystems Division, making it an ideal component in any Lean Histology™ workflow.

The Biosystems Division of Leica Microsystems brings histopathology labs and researchers the highest quality, most comprehensive product range. From patient to pathologist, the range includes the ideal product for each histology step and high-productivity workflow solutions for the entire lab. With complete histology systems featuring innovative automation and Novocastra reagents, Leica Microsystems creates better patient care through rapid turnaround, diagnostic confidence and close customer collaboration.