MAGE-A4 IHC 1F9 pharmDx

Code SK032

MAGE-A4 IHC 1F9 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 diagnostically positive if MAGE-A4 TIPS at ≥ 2+ staining intensity 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.

MAGE-A4 IHC 1F9 pharmDx Kit
The kit contains optimized reagents and protocol required to perform an IHC staining run on FFPE specimens using the PT Link Pre-Treatment Module and Autostainer Link 48. The materials provided are sufficient for 50 tests (50 slides incubated with the primary antibody to the MAGE-A4 protein, and 50 slides incubated with Negative Control Reagent (100 slides in total).

TECELRA® is a registered trademark of Adaptimmune Limited and its affiliates.

MAGE A4 mouse monoclonal antibody clone OTI1F9 is licensed from OriGene Technologies.