BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P170019 · Decision Nov 30, 2017
    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 CDx
    PMA Number
    P170019
    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
    November 30, 2017
    Date Received
    June 2, 2017
    Expedited Review
    Y
    Docket Number
    17M-6799

    Advisory Committee Statement

    Approval for the FoundationOne CDx (F1CDx). This device is a next generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens. The test is intended 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. Additionally, F1CDx 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. The F1CDx assay is a single-site assay performed at Foundation Medicine, Inc.Table 1: Companion diagnostic indicationsIndication: Non-small cell lung cancer (NSCLC). - Biomarker: EGFR exon 19 deletions and EGFR exon 21 L858R alterations. Therapy: Gilotrif® (afatinib), Iressa® (gefitinib), or Tarceva® (erlotinib). - Biomarker: EGFR exon 20 T790M alterations. Therapy: Tagrisso® (osimertinib). - Biomarker: ALK rearrangements. Therapy: Alecensa® (alectinib), Xalkori® (crizotinib), or Zykadia® (ceritinib). - Biomarker: BRAF V600E. Therapy: Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib).Indication: Melanoma. - Biomarker: BRAF V600E. Therapy: Tafinlar® (dabrafenib) or Zelboraf® (vemurafenib) - Biomarker: BRAF V600E and V600K. Therapy: Mekinist® (trametinib) or Cotellic® (cobimetinib) in combination with Zelboraf® (vemurafenib).Indication: Breast cancer. Biomarker: ERBB2 (HER2) amplification. Therapy: Herceptin® (trastuzumab), Kadcyla® (ado-trastuzumab-emtansine), orPerjeta® (pertuzumab).Indication: Colorectal cancer. - Biomarker: KRAS wild-type (absence of mutations in codons 12 and 13). Therapy: Erbitux® (cetuximab) - Biomarker: KRAS wild-type (absence of mutations in exons 2, 3, and 4) and NRAS wild type (absence of mutations in exons 2, 3, and 4). Therapy: Vectibix® (panitumumab)Indication: Ovarian cancer. Biomarker: BRCA1/2 alterations. Therapy: Rubraca® (rucaparib)

    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