^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners

    TEST:
    VENTANA ALK (D5F3) CDx Assay

    Company:
    Roche
    Type:
    FDA Approved
    Related tests:
    VENTANA ALK (D5F3) CDx Assay is intended for the qualitative detection of the anaplastic lymphoma kinase (ALK) protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung carcinoma (NSCLC) tissue stained with a BenchMark XT or BenchMark ULTRA automated staining instrument. It is indicated as an aid in identifying patients eligible for treatment with XALKORI® (crizotinib), ZYKADIA® (ceritinib), or ALECENSA® (alectinib).
    Cancer:
    Non Small Cell Lung Cancer
    Gene:
    ALK (Anaplastic lymphoma kinase)
    Drug:
    Alecensa (alectinib), Lorbrena (lorlatinib), Xalkori (crizotinib), Zykadia (ceritinib)
    Method:
    Immunohistochemistry (IHC)
    Approvals
    Date
    Cancer
    Gene
    Drug
    By
    06/12/15
    NSCLC
    ALK
    crizotinib
    FDA
    05/26/17
    NSCLC
    ALK
    ceritinib
    FDA
    11/06/17
    NSCLC
    ALK
    alectinib
    FDA
    03/03/21
    NSCLC
    ALK
    lorlatinib
    FDA
    Confirmatory trial(s)
    PROFILE 1001
    ,
    NCT00585195
    |
    Ann Oncol