BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    PMA: P230011 · Decision Aug 21, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12

    Basic Information

    Device Name
    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
    Trade Name
    TruSight Oncology Comprehensive
    PMA Number
    P230011
    Device Class
    FDA Class 3
    Product Code
    PQP
    Generic Name
    Next generation sequencing oncology panel, somatic or germline variant detection system
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 21, 2024
    Date Received
    March 20, 2023
    Expedited Review
    N

    Advisory Committee Statement

    TruSight Oncology Comprehensive is a qualitative in vitro diagnostic test that uses targeted next-generation sequencing to detect variants in 517 genes using nucleic acids extracted from formalin-fixed, paraffin embedded (FFPE) tumor tissue samples from cancer patients with solid malignant neoplasms using the Illumina® NextSeq™ 550Dx instrument. The test can be used to detect single nucleotide variants, multi- nucleotide variants, insertions, and deletions from DNA, and fusions in 24 genes and splice variants in one gene from RNA. The test also reports a Tumor Mutational Burden (TMB) score.The test is intended to be used as a companion diagnostic to identify cancer patients who may benefit from treatment with the targeted therapies listed in Table 1, in accordance with the approved therapeutic product labeling. In addition, the test is intended to provide tumor profiling information for use by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Genomic findings other than those listed in Table 1 of the intended use statement are not conclusive or prescriptive for labeled use of any specific therapeutic product.

    Classifications

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

    Product Code Device Name
    PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System