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Agilent's MAGE-A4 IHC 1F9 pharmDx Gets FDA Approval as Diagnostic Tool for New TCR T-Cell Therapy

NextEdge Admin

03 Aug 2024

2 min 3 sec

Agilent Technologies Inc. has announced that it has received FDA approval for its MAGE-A4 IHC 1F9 pharmDx (SK032) as a diagnostic tool to identify patients with synovial sarcoma who may be eligible for treatment with TECELRA® (afamitresgene autoleucel, also known as afami-cel or ADP-A2M4), a MAGE-A4-directed engineered TCR T-Cell therapy.

MAGE-A4, a cancer-testis antigen, is overexpressed in various cancers, including synovial sarcoma. The MAGE-A4 IHC 1F9 pharmDx is an immunohistochemistry (IHC) assay designed to detect MAGE-A4 expression in formalin-fixed paraffin-embedded (FFPE) synovial sarcoma tissue. Detection of MAGE-A4 in synovial sarcoma serves as a biomarker indicating potential eligibility for TECELRA® treatment. This marks MAGE-A4 IHC 1F9 pharmDx as the first in vitro diagnostic (IVD) test for MAGE-A4 available on the market.

Lou Welebob, Agilent’s vice president and general manager of the Pathology Division, emphasized that MAGE-A4's significant role in cancer research highlights its potential as a therapeutic target. The FDA's approval enhances treatment options for patients with synovial sarcoma and underscores Agilent’s leadership in developing companion diagnostics for innovative cancer therapies.

TECELRA® is an FDA-approved prescription therapy for advanced MAGE-A4 positive synovial sarcoma in adults with specific HLA types who have undergone prior chemotherapy. It represents the first FDA-approved engineered TCR T-Cell therapy for solid tumor cancers.