MAGE-A4 IHC 1F9 pharmDx

FDA premarket approval P230016 · Immunohistochemistry Assay, Antibody, Melanoma-associated antigen A4

PMA numberP230016

Approval

Applicant
Agilent Technologies, Inc.
Received
May 1, 2023
Decision date
August 1, 2024 (APPR)
Supplements
3, latest September 11, 2026
Product code
SBL – Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4

Official FDA PMA record

Approval order statement

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 tissues 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 adult patients with synovial sarcoma for whom TECELRA® (afamitresgene autoleucel), a MAGE-A4 directed genetically modified autologous T- cell immunotherapy is being considered.