# MAGE-A4 IHC 1F9 pharmDx

Source: https://onco.cc/drugs/mage-a4-ihc-1f9-pharmdx/  
OnCo record `mage-a4-ihc-1f9-pharmdx` (Test). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The stain that shows whether a synovial sarcoma makes MAGE-A4, the target of the engineered T-cell therapy afamitresgene autoleucel.

## Summary

Agilent's MAGE-A4 IHC 1F9 pharmDx was approved on 1 August 2024 (PMA P230016) as the companion diagnostic for afamitresgene autoleucel in synovial sarcoma with MAGE-A4 protein overexpression. Eligibility also needs a matching HLA type, tested separately with the SeCore CDx HLA Sequencing System.

## Fields

- Kind: Test
- Status: approved
- Last checked: 2026-11-03
- Tags: test
- Brand: MAGE-A4 IHC 1F9 pharmDx
- Modality: Immunohistochemistry companion diagnostic assay (MAGE-A4 protein, sarcoma tissue)
- Mechanism: Immunohistochemistry with the 1F9 antibody for MAGE-A4 protein in synovial sarcoma tissue.
- Approvals: US 2024: Companion diagnostic for afamitresgene autoleucel in synovial sarcoma (MAGE-A4 protein)

## Sources

- FDA PMA P230016: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230016
- 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: [Afamitresgene autoleucel](https://onco.cc/drugs/afamitresgene-autoleucel/), [SeCore CDx HLA Sequencing System](https://onco.cc/drugs/secore-cdx-hla/)
- biomarkers: [HLA-A*02:01 (HLA typing for TCR therapies)](https://onco.cc/biomarkers/hla-a-02-01/)
- cancers: [Synovial sarcoma](https://onco.cc/cancers/synovial-sarcoma/)
- technologies: [Companion diagnostics](https://onco.cc/technologies/companion-diagnostic/), [Histopathology & immunohistochemistry](https://onco.cc/technologies/histopathology-ihc/)
- targets: [MAGE-A4](https://onco.cc/targets/mage-a4/)
- 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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