BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P160045 · Decision Jun 22, 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
    Oncomine Dx Target Test
    PMA Number
    P160045
    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
    June 22, 2017
    Date Received
    October 17, 2016
    Expedited Review
    N
    Docket Number
    17M-3928

    Advisory Committee Statement

    Approval for the The Oncomine Dx Target Test is a qualitative in vitro diagnostic test that uses targeted high throughput, parallel-sequencing technology to detect single nucleotide variants (SNVs) and deletions in 23 genes from DNA and fusions in ROS1 from RNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples from patients with non-small cell lung cancer (NSCLC) using the Ion PGM Dx System. The test is indicated to aid in selecting NSCLC patients for treatment with the targeted therapies listed in Table 1 in accordance with the approved therapeutic product labeling.Table 1. List of variants for therapeutic useGene Variant Targeted therapyBRAF BRAF V600E TAFINLAR® (dabrafenib) in combination with MEKINIST® (trametinib)ROS1 ROS1 fusions XALKORI® (crizotinib)EGFR L858R, Exon 19 deletions IRESSA® (gefitinib)Safe and effective use has not been established for selecting therapies using this device for the variants in Table 1 in tissue types other than NSCLC.Results other than those listed in Table 1 are indicated for use only in patients who have already been considered for all appropriate therapies (including those listed in Table 1). Analytical performance using NSCLC specimens has been established for the variants listed in Table 2.Table 2. List of variants with established analytical performance onlyGene Variant ID Nucleotide changeKRAS COSM512 c.34_35delGGinsTTKRAS COSM516 c.34G>TMET COSM707 c.3029C>TPIK3CA COSM754 c.1035T>AThe test is not indicated to be used for standalone diagnostic purposes, screening, monitoring, risk assessment, or prognosis.

    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