Agilent Technologies Inc. (NYSE: A) has announced FDA approval for its MAGE-A4 IHC 1F9 pharmDx (SK032) as a diagnostic tool to identify patients with synovial sarcoma who may qualify for TECELRA® (afamitresgene autoleucel, or afami-cel), a MAGE-A4-directed engineered TCR T-Cell therapy.
“This approval highlights Agilent’s leading role in developing companion diagnostics for innovative cancer treatments,” said Lou Welebob, Vice President and General Manager of Agilent’s Pathology Division.
MAGE-A4 (melanoma-associated antigen A4) is a cancer-testis antigen found in various cancers, including synovial sarcoma. The MAGE-A4 IHC 1F9 pharmDx is an immunohistochemistry (IHC) assay that detects MAGE-A4 expression in formalin-fixed paraffin-embedded (FFPE) synovial sarcoma tissue. Detecting MAGE-A4 positivity indicates eligibility for TECELRA® treatment. This is the first MAGE-A4 IVD available on the market.
“Given MAGE-A4’s significance in cancer research and its potential as a therapeutic target, the FDA’s approval will broaden treatment options for patients with synovial sarcoma,” Welebob added.
TECELRA® is a prescription medicine approved for advanced MAGE-A4 positive synovial sarcoma in adults with specific HLA types who have undergone prior chemotherapy. It is the first FDA-approved engineered TCR T-Cell therapy for solid tumors.
About Agilent Technologies
Agilent Technologies Inc. (NYSE: A) is a global leader in analytical and clinical laboratory technologies, providing solutions that support scientific advancement. Agilent offers a comprehensive range of instruments, software, services, and expertise to address complex questions. The company generated $6.83 billion in revenue in fiscal 2023 and employs approximately 18,000 people worldwide.
