# Bond Oracle HER2 IHC System

Source: https://onco.cc/drugs/bond-oracle-her2-ihc/  
OnCo record `bond-oracle-her2-ihc` (Test). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Leica's HER2 stain for breast cancer, listed by the FDA as a companion to trastuzumab.

## Summary

Leica Biosystems' Bond Oracle HER2 IHC System was approved on 18 April 2012 (PMA P090015) and is listed as a companion diagnostic for trastuzumab in breast cancer, detecting HER2 protein overexpression.

## Fields

- Kind: Test
- Status: approved
- Last checked: 2026-11-03
- Tags: test
- Brand: Bond Oracle HER2 IHC System
- Modality: Immunohistochemistry companion diagnostic assay (HER2 protein, breast tumour tissue)
- Mechanism: Immunohistochemistry for HER2 protein in breast tumour tissue.
- Approvals: US 2012: HER2 protein overexpression to select trastuzumab in breast cancer

## Sources

- FDA PMA P090015: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P090015
- FDA: List of cleared or approved companion diagnostic devices: https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools

## Connected records

- drugs: [HER2 IHC and ISH companion assays (HercepTest, PATHWAY 4B5, HER2 Dual ISH)](https://onco.cc/drugs/her2-testing-assays/), [Trastuzumab](https://onco.cc/drugs/trastuzumab/)
- biomarkers: [HER2 IHC 3+ (HER2-positive by immunohistochemistry)](https://onco.cc/biomarkers/her2-ihc-3-plus/)
- cancers: [HER2-positive breast cancer](https://onco.cc/cancers/breast-her2-positive/)
- technologies: [Companion diagnostics](https://onco.cc/technologies/companion-diagnostic/), [Histopathology & immunohistochemistry](https://onco.cc/technologies/histopathology-ihc/)
- targets: [HER2](https://onco.cc/targets/her2/)
- companies: [Leica Biosystems (Danaher)](https://onco.cc/companies/leica-biosystems/)
- terms: [Companion diagnostic](https://onco.cc/terms/companion-diagnostic-term/), [HER2-positive (IHC 3+ or ISH-amplified)](https://onco.cc/terms/her2-positive/), [Immunohistochemistry (IHC)](https://onco.cc/terms/ihc/)

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