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    TEST:
    Bond Oracle HER2 IHC System

    Company:
    Danaher Corp
    Type:
    FDA Approved
    Related tests:
    Bond Oracle HER2 IHC System for BOND-MAX is a semi-quantitative immunohistochemical (IHC) assay to determine HER2 (Human Epidermal Growth Factor Receptor 2) oncoprotein status in formalin-fixed, paraffin-embedded breast cancer tissue processed for histological evaluation following automated staining on the BOND-MAX slide staining instrument. The Bond Oracle HER2 IHC System for BOND-MAX is indicated as an aid in the assessment of patients for whom Herceptin® (trastuzumab) treatment is being considered.
    Cancer:
    Breast Cancer
    Gene:
    HER-2 (Human epidermal growth factor receptor 2)
    Drug:
    Herceptin (trastuzumab)
    Method:
    Immunohistochemistry (IHC)
    Approvals
    Date
    Cancer
    Gene
    Drug
    By
    04/18/12
    BC
    HER-2
    trastuzumab
    FDA
    Confirmatory trial(s)
    PRESENT
    ,
    NCT01479244
    |
    J Clin Oncol