# HER2 FISH pharmDx Kit

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

## TL;DR

Dako's HER2 gene test, listed as companion to trastuzumab, pertuzumab and trastuzumab emtansine.

## Summary

The HER2 FISH pharmDx Kit (Dako, now part of Agilent) was approved on 3 May 2005 (PMA P040005) for trastuzumab in breast cancer. Supplements extended it to trastuzumab in gastric and gastro-oesophageal cancer (20 October 2010), pertuzumab in breast cancer (8 June 2012) and trastuzumab emtansine in breast cancer (22 February 2013).

## Fields

- Kind: Test
- Status: approved
- Last checked: 2026-11-03
- Tags: test
- Brand: HER2 FISH pharmDx
- Modality: FISH companion diagnostic test (HER2 gene amplification, tumour tissue)
- Mechanism: Fluorescence in situ hybridisation measuring HER2 (ERBB2) gene amplification in breast or gastric tumour tissue.
- Approvals: US 2005: Companion diagnostic for trastuzumab in breast cancer; US 2010: Trastuzumab in gastric and gastro-oesophageal cancer; US 2012: Pertuzumab in breast cancer; US 2013: Trastuzumab emtansine in breast cancer

## Sources

- FDA PMA P040005: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P040005
- 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/), [PathVysion HER-2 DNA Probe Kit](https://onco.cc/drugs/pathvysion-her2/), [Pertuzumab](https://onco.cc/drugs/pertuzumab/), [Trastuzumab](https://onco.cc/drugs/trastuzumab/), [Trastuzumab emtansine](https://onco.cc/drugs/trastuzumab-emtansine/)
- biomarkers: [HER2 ISH amplified (ERBB2 gene amplification)](https://onco.cc/biomarkers/her2-ish-amplified/)
- cancers: [HER2-positive breast cancer](https://onco.cc/cancers/breast-her2-positive/), [HER2-positive gastric cancer](https://onco.cc/cancers/gastric-her2-positive/)
- technologies: [Companion diagnostics](https://onco.cc/technologies/companion-diagnostic/), [Cytogenetics and FISH](https://onco.cc/technologies/cytogenetics-fish/)
- targets: [HER2](https://onco.cc/targets/her2/)
- companies: [Agilent Technologies (Dako)](https://onco.cc/companies/agilent/)
- terms: [Companion diagnostic](https://onco.cc/terms/companion-diagnostic-term/), [FISH / ISH (in situ hybridisation)](https://onco.cc/terms/fish/), [HER2-positive (IHC 3+ or ISH-amplified)](https://onco.cc/terms/her2-positive/)

---
JSON: https://onco.cc/api/v1/entities/her2-fish-pharmdx.json