BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P250031 · Decision Jun 12, 2026
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    Classifications
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    FEI Numbers
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    Basic Information

    Trade Name
    VENTANA PTEN (SP218) RxDx Assay
    PMA Number
    P250031
    Product Code
    SHF
    Generic Name
    Immunohistochemistry Assay, Antibody, phosphatase and tensin homolog (PTEN)
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 12, 2026
    Date Received
    August 18, 2025
    Expedited Review
    N
    Docket Number
    26M-6735

    Advisory Committee Statement

    VENTANA PTEN (SP218) RxDx Assay is a qualitative immunohistochemical (IHC) assay using rabbit monoclonal anti-PTEN, clone SP218, intended for laboratory use in the assessment of phosphatase and tensin homolog (PTEN) protein in formalin-fixed paraffin-embedded (FFPE) prostatic adenocarcinoma tissue specimens by light microscopy. The assay is for use with OptiView DAB IHC Detection Kit on a BenchMark ULTRA instrument. The assay is indicated as a companion diagnostic to aid in identifying patients who may be eligible for treatment with TRUQAP (capivasertib) in combination with abiraterone acetate in accordance with the approved therapeutic product labeling. The clinical cutoff for PTEN Loss status is = 90% of viable malignant cells with no specific cytoplasmic staining.Test results should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls.This product is intended for in vitro diagnostic (IVD) use.