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    TEST:
    VENTANA CLDN18 (43-14A) Assay

    Company:
    Roche
    Type:
    FDA Approved
    Related tests:
    VENTANA CLDN18 (43-14A) Assay is intended for the immunohistochemical detection of the Claudin 18 (CLDN18) protein in formalin-fixed, paraffin-embedded (FFPE) neoplastic tissues stained with BenchMark IHC/ISH instruments. This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls. This antibody is intended for in vitro diagnostic (IVD) use.
    Cancer:
    Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
    Gene:
    CLDN18 (Claudin 18)
    Method:
    Immunohistochemistry (IHC)
    Approvals
    Date
    Cancer
    Gene
    Drug
    By
    10/10/24
    GC
    CLDN18
    zolbetuximab-clzb
    CE
    GC
    10/18/24
    GC
    CLDN18
    zolbetuximab-clzb
    FDA
    GC
    Confirmatory trial(s)
    Spotlight
    ,
    NCT03504397
    |
    ECP 2023
    GLOW
    ,
    NCT03653507
    |
    ECP 2023