BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Nucleic Acid Based Assay, Microsatellite Instability

    PMA: P240026 · Decision Nov 5, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Nucleic Acid Based Assay, Microsatellite Instability
    Trade Name
    OncoMate® MSI Dx Analysis System
    PMA Number
    P240026
    Device Class
    FDA Class 3
    Product Code
    SFL
    Generic Name
    Nucleic Acid Based Assay, Microsatellite Instability
    Medical Specialty
    Unknown
    Advisory Committee
    Medical Genetics
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 5, 2025
    Date Received
    July 26, 2024
    Expedited Review
    N
    Docket Number
    FDA-6100

    Advisory Committee Statement

    Approval for the OncoMate® MSI Dx Analysis System. The OncoMate® MSI Dx Analysis System is a qualitative multiplex polymerase chain reaction (PCR) test intended to detect the deletion of mononucleotides in five microsatellite loci (BAT-25, BAT-26, NR-21, NR-24 and MONO-27) for the identification of microsatellite instability (MSI) using DNA obtained from formalin-fixed, paraffin-embedded (FFPE) endometrial carcinoma tissue specimens, and DNA isolated from matched normal FFPE specimen or whole blood. The OncoMate® MSI Dx Analysis System is for use with the Applied Biosystems® 3500 Dx Genetic Analyzer and OncoMate® MSI Dx Analysis Software.The OncoMate® MSI Dx Analysis System is indicated for use as a companion diagnostic test to identify patients with microsatellite stable (MSS; defined as not MSI-high [not MSI-H]) endometrial carcinoma who may benefit from treatment with KEYTRUDA® (pembrolizumab) in combination with LENVIMA® (lenvatinib) in accordance with the approved therapeutic product labeling.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    SFL Nucleic Acid Based Assay, Microsatellite Instability