# EGFR pharmDx

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

## TL;DR

The 2004 EGFR protein stain approved with cetuximab for bowel cancer; the FDA database records it as withdrawn in 2024.

## Summary

Dako's EGFR pharmDx Kit (Dako is now part of Agilent) was approved on 12 February 2004 (PMA P030044) for cetuximab in colorectal cancer, and a supplement on 27 September 2006 added panitumumab. The FDA PMA database records a withdrawal date of 11 April 2024, although the kit still appeared on the FDA companion diagnostic list when both were read on 3 November 2026.

## Fields

- Kind: Test
- Status: withdrawn
- Last checked: 2026-11-03
- Also known as: Dako EGFR pharmDx Kit; DakoCytomation EGFR pharmDx
- Tags: test
- Brand: Dako EGFR pharmDx Kit
- Modality: Immunohistochemistry companion diagnostic assay (EGFR protein, colorectal tumour tissue)
- Mechanism: Immunohistochemistry for EGFR (HER1) protein in colorectal tumour tissue.
- Approvals: US 2004: EGFR protein expression for cetuximab in colorectal cancer; US 2006: EGFR protein expression for panitumumab in colorectal cancer

## Notes

- PMA P030044 shows a withdrawal date of 11 April 2024 in the FDA PMA database (read 3 November 2026).

## Sources

- FDA PMA P030044: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030044
- 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

- cancers: [Colorectal cancer](https://onco.cc/cancers/colorectal/)
- technologies: [Companion diagnostics](https://onco.cc/technologies/companion-diagnostic/), [Histopathology & immunohistochemistry](https://onco.cc/technologies/histopathology-ihc/)
- targets: [EGFR](https://onco.cc/targets/egfr/)
- drugs: [Cetuximab](https://onco.cc/drugs/cetuximab/), [Panitumumab](https://onco.cc/drugs/panitumumab/)
- companies: [Agilent Technologies (Dako)](https://onco.cc/companies/agilent/)
- terms: [Companion diagnostic](https://onco.cc/terms/companion-diagnostic-term/), [Immunohistochemistry (IHC)](https://onco.cc/terms/ihc/)

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