BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P160045 · Supplement: S019 · Decision Sep 4, 2020
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    Oncomine Dx Target Test
    PMA Number
    P160045
    Supplement Number
    S019
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 4, 2020
    Date Received
    April 1, 2020
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    20M-1988

    Advisory Committee Statement

    Approval to expand the intended use of the Oncomine Dx Target Test to include a companion diagnostic indication for the detection of RET fusions in non-small cell lung cancer patients who may benefit from treatment with GAVRETO (pralsetinib).