Agilent Technologies, Inc. announced on Friday that it has secured FDA approval for the MAGE-A4 IHC 1F9 pharmDx, a diagnostic tool aimed at identifying synovial sarcoma patients who may qualify for treatment with the newly approved TECELRA. This MAGE-A4-directed engineered TCR T-Cell therapy represents a significant advancement in the field.
The MAGE-A4 IHC 1F9 pharmDx is an immunohistochemistry (IHC) assay capable of detecting MAGE-A4 expression in formalin-fixed paraffin-embedded (FFPE) synovial sarcoma tissue. Notably, it is the first in vitro diagnostic (IVD) tool for MAGE-A4 that is available on the market.
TECELRA, developed by Adaptimmune Therapeutics plc, recently received FDA approval under the accelerated approval pathway for advanced MAGE-A4+ synovial sarcoma in adults with specific human leukocyte antigen (HLA) types, following prior chemotherapy.
Lou Welebob, Vice President and General Manager of Agilent's Pathology Division, remarked, "MAGE-A4 is pivotal in cancer research and shows great potential as a therapeutic target. The FDA's approval of Agilent's MAGE-A4 IHC 1F9 pharmDx will broaden treatment options for those diagnosed with synovial sarcoma."
As of the latest trading session, Agilent Technologies is priced at $139.62, reflecting a decrease of 3.24%.
