Leica Oracle™ HER2 Bond™ IHC


Overview


The Leica Oracle HER2 Bond IHC System offers a fully automated, robust and dependable test for the accurate assessment of HER2 status in breast cancer tissue. Now you can rely on a system with Novocastra™ science optimized for Bond automated staining. With a complete package integrating antibody (Clone CB11, improved formulation), control slides and ancillary reagents, Oracle is the wise choice for consistently accurate HER2 assessment.

Note: This product is not available in North America. Please check with you local sales representative for availability and regulatory approval in your region.


Key features

  • Accurate – control slides with four cell lines (0, 1+, 2+ and 3+) increase assay
    validation confidence
  • Sensitive – Compact Polymer™ detection for consistency, specificity and
    diagnostic clarity
  • Complete – an integrated system of reagents and automation for consistent,
    high-quality results


    • Detailed Description


    The Leica 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 (see Herceptin® package insert).

    The Oracle HER2 Bond IHC System contains components required to complete an immunohistochemical staining procedure for formalin-fixed, paraffin-embedded tissues. Each system includes the ready-to-use HER2 Primary Antibody (clone CB11, reformulated), Compact Polymer detection system and hematoxylin counterstain. Control slides with four formalin-fixed, paraffin-embedded human breast cancer cell lines are provided to validate staining runs. The four cell lines demonstrate HER2 oncoprotein expression at 0, 1+, 2+ and 3+ intensities. The staining intensity of these cell lines has been correlated to both HER2 oncoprotein receptor load per cell and HER2 gene status. The Oracle HER2 Bond IHC System is for use on the Leica Bond-max™ fully automated advanced staining system.

    The order code for the Oracle HER2 Bond IHC System is TA9145 and each system includes: