Home·Explore by Test·Bond Oracle HER2 IHC System
FDA-approved companion diagnostic

Bond Oracle HER2 IHC System

Fully automated IHC assay on the BOND platform that semi-quantitatively assesses HER2 oncoprotein expression in breast cancer tissue to guide HER2-targeted treatment decisions.

IVD-developed CDxMethod: IHCSpecimen: Tissue (FFPE)Biomarker: HER2
Ready to order?

Casandra.ai provides a unified ordering experience so you can request this test directly from the performing lab, without changing your workflow.

Ordering is available where Casandra has an active integration with the performing lab. Labs that offer this test can connect with us to enable digital ordering.

About this test

FDA approval details
PMA number
P090015
Supplements
Manufacturer
Leica Biosystems
Approval date
April 18, 2012
Test specifications
Methodology
IHC
Specimen
Tissue (FFPE)
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
HER2
What this test is

Bond Oracle HER2 IHC System is an FDA-approved, semi-quantitative immunohistochemical assay that uses a monoclonal anti-HER2 antibody on the fully automated BOND stainer to determine HER2 oncoprotein status in formalin-fixed, paraffin-embedded breast cancer tissue. Standardized 0–3+ scoring supports accurate classification of HER2-negative, equivocal, and positive tumors for treatment planning and possible reflex testing.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Breast CancerERBB2 (HER2)HER-2 protein overexpressionHERCEPTIN

IVD Manufacturer

Leica Biosystems

Leica Biosystems is a cancer diagnostics company and a global leader in anatomic and digital pathology solutions. The company offers a comprehensive product range for each step in the pathology process, from sample preparation and staining to imaging and reporting. As the only company to own the full workflow from biopsy to diagnosis, Leica Biosystems is uniquely positioned to break down the barriers between each step. The company’s mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of its corporate culture. Leica Biosystems is proud to be a Danaher Corporation subsidiary.

Order this test

If your organization is connected to Casandra, you can place an electronic order forBond Oracle HER2 IHC System directly from your existing workflow.

Casandra connects providers, labs, and sponsored programs so that companion diagnostics can be ordered consistently and documented cleanly, regardless of which system you start from.

CDxTests.com is an informational resource for providers. Always refer to the official FDA labeling and laboratory documentation when making treatment decisions.

© 2025 Casandra.ai

Bond Oracle HER2 IHC System - CDxTests.com | CDx Tests