FDA Greenlights Agilent's MAGE-A4 IHC 1F9 PharmDx For Use With Newly Approved TECELRA

(RTTNews) - Agilent Technologies, Inc. (A) on Friday announced that it has obtained FDA approval for MAGE-A4 IHC 1F9 pharmDx, a diagnostic tool designed to identify patients with synovial sarcoma who may be eligible for treatment with newly approved TECELRA, a MAGE-A4-directed engineered TCR T-Cell therapy.

MAGE-A4 IHC 1F9 pharmDx is an immunohistochemistry (IHC) assay that detects MAGE-A4 expression in formalin-fixed paraffin-embedded (FFPE) synovial sarcoma tissue and is the first in vitro diagnostic (IVD) tool for MAGE-A4 available on the market.

TECELRA, developed by Adaptimmune Therapeutics plc (ADAP) received FDA approval under accelerated approval pathway as recently as yesterday for advanced MAGE-A4+synovial sarcoma in adults with certain human leukocyte antigens (HLA) types who have received prior chemotherapy.

Lou Welebob, vice president and general manager of Agilent's Pathology Division, said, "MAGE-A4 plays a significant role in cancer research and holds promise as a therapeutic target. The FDA's approval of Agilent's MAGE-A4 IHC 1F9 pharmDx will expand treatment options for individuals diagnosed with synovial sarcoma."

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