BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cancer-Related Germline Gene Mutation Detection System

    PMA: P190014 · Supplement: S011 · Decision Mar 10, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Cancer-Related Germline Gene Mutation Detection System
    Trade Name
    MyChoice® CDx
    PMA Number
    P190014
    Supplement Number
    S011
    Device Class
    FDA Class 3
    Product Code
    PJG
    Generic Name
    Cancer-related germline gene mutation detection system
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 10, 2026
    Date Received
    September 16, 2025
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval to update the MyChoice CDx assay labeling from a complementary diagnostic to a companion diagnostic to aid in identifying ovarian cancer patients with deleterious or suspected deleterious germline or somatic BRCA1 and BRCA2 mutations and/or a positive genomic instability score, who are eligible or may become eligible for treatment with Zejula (niraparib).

    Classifications

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

    Product Code Device Name
    PJG Cancer-Related Germline Gene Mutation Detection System