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    TEST:
    FoundationFocus CDxBRCA Assay

    Company:
    Roche
    Type:
    FDA Approved
    Related tests:
    FoundationFocus™ CDxBRCA LOH 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. This laboratory test is used to determine if patients previously treated for ovarian cancer may benefit from treatment with Rubraca™ (rucaparib).
    Cancer:
    Ovarian Cancer
    Gene:
    BRCA1 (Breast cancer 1, early onset), BRCA2 (Breast cancer 2, early onset)
    Drug:
    Rubraca (rucaparib)
    Method:
    Next-Generation Sequencing (NGS)
    Approvals
    Date
    Cancer
    Gene
    Drug
    By
    12/19/16
    OC
    BRCA1
    rucaparib
    FDA
    BRCA2
    01/19/17
    OC
    -
    CE
    Confirmatory trial(s)
    NCT01482715
    |
    Int J Gynecol Cancer