- Device
- MAGE-A4 IHC 1F9 pharmDx
- Applicant
- Agilent Technologies, Inc.
- PMA number
- P230016
- Supplement
- S003
- Product code
- SBL
- Generic name
- Immunohistochemistry Assay, Antibody, Melanoma-associated antigen A4
- Decision date
- 2026-09-15
- Decision code
- APPR
- Date received
- 2026-05-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- MAGE-A4 IHC IF9 pharmDx is a qualitative immunohistochemical (IHC) assay using monoclonal mouse anti-MAGE-A4, Clone OTI1F9, intended for use in the detection of MAGE-A4 protein in formalin-fixed, paraffin-embedded (FFPE) synovial sarcoma tissue using the EnVision FLEX visualization system on Autostainer Link 48. MAGE-A4 protein expression in synovial sarcoma is determined by using the MAGE-A4 Tumor Intensity Proportion Score (TIPS), which is the overall percentage of viable tumor cells showing MAGE-A4 nuclear and/or cytoplasmic staining at staining intensity = 2+. The specimen should be considered positive if MAGE-A4 TIPS (= 2+) is = 75%.MAGE-A4 IHC 1F9 pharmDx is indicated as an aid in identifying patients with synovial sarcoma for whom TECELRA® (afamitresgene autoleucel), a MAGE-A4-directed genetically modified autologous T-cell immunotherapy, is being considered.