BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P160018 · Supplement: S001 · Decision Apr 6, 2018
    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
    FoundationFocus CDx BRCA HRD
    PMA Number
    P160018
    Supplement Number
    S001
    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
    April 6, 2018
    Date Received
    September 28, 2017
    Supplement Type
    Panel Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N
    Docket Number
    18M-1446

    Advisory Committee Statement

    Approval for the FoundationFocus™ CDx BRCA LOH. The device is an assay that uses next-generation sequencing (NGS) for qualitative detection of BRCA1 and BRCA2 sequence alterations and genomic loss of heterozygosity (LOH) from formalin-fixed, paraffin-embedded (FFPE) ovarian tumor tissue. Results of the test are used as an aid in identifying ovarian cancer patients with deleterious tumor BRCA variants (tBRCA-positive), who may be eligible for treatment with Rubraca (rucaparib). Positive homologous recombination deficiency (HRD) status (defined as tBRCA-positive or LOH high) in ovarian cancer patients is associated with improved progression-free survival (PFS) from Rubraca (rucaparib) maintenance therapy. See the RUBRACA product label for information about guiding therapy in specific clinical circumstances. This test is to be performed at Foundation Medicine, Inc., a single laboratory site, located at 150 Second Street, Cambridge, Massachusetts.

    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