BEUDAMED
    FDA PMA FDA Class 3 🇺🇸 United States

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

    PMA: P200016 · Decision Nov 6, 2020
    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
    FoundationOne Liquid CDx
    PMA Number
    P200016
    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
    Medical Genetics
    Decision Code
    APCB
    Decision Date
    November 6, 2020
    Date Received
    March 9, 2020
    Expedited Review
    N
    Docket Number
    20M-2191

    Advisory Committee Statement

    Approval for the FoundationOne® Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test that uses targeted high throughput hybridization-based capture technology to detect and report substitutions, insertions and deletions (indels) in 311 genes, including rearrangements in four (4) genes, and copy number alterations in three (3) genes. FoundationOne® Liquid CDx utilizes circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of cancer patients collected in FoundationOne® Liquid CDx cfDNA blood collection tubes included in the FoundationOne® Liquid CDx Blood Sample Collection Kit. The test is intended to be used as a companion diagnostic to identify patients who may benefit from treatment with the targeted therapies listed in Table 1 in accordance with the approved therapeutic product labeling. Table 1: Companion diagnostic indicationsTumor Type Biomarker(s) Detected TherapyNon-small cell lung cancer (NSCLC) ALK Rearrangements ALECENSA® (alectinib) EGFR Exon 19 deletions andEGFR Exon 21 L858R alteration IRESSA® (gefitinib)TAGRISSO® (osimertinib)TARCEVA® (erlotinib)Prostate cancer BRCA1, BRCA2, and ATM alterations LYNPARZA® (olaparib) BRCA1, BRCA2 alterations RUBRACA® (rucaparib)Ovarian Cancer BRCA1, BRCA2 alterations RUBRACA® (rucaparib)Breast Cancer PIK3CA mutations C420R, E542K, E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R, H1047L, H1047R, and H1047Y PIQRAY® (alpelisib)Additionally, FoundationOne® Liquid CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms.A negative result from a plasma specimen does not mean that the patients tumor is negative for genomic findings. Patients who are negative for the mutations listed in Table 1 should be reflexed to routine biopsy and their tumor mutation status confirmed using an FDA-approved tumor tissue test, if feasible.Genomic findings other than those listed in Table 1 of the intended use statement are not prescriptive or conclusive for labeled use of any specific therapeutic product. FoundationOne® Liquid CDx is a single-site assay performed at Foundation Medicine, Inc. in Cambridge, MA.

    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