BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P200011 · Decision Jul 30, 2021
    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
    ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA)
    PMA Number
    P200011
    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
    Approved
    Decision Code
    APPR
    Decision Date
    July 30, 2021
    Date Received
    February 18, 2020
    Expedited Review
    N
    Docket Number
    21M-0853

    Advisory Committee Statement

    Approval of the ONCO/RevealTM Dx Lung and Colon Cancer Assay (O/RDx-LCCA). The device is a qualitative next generation sequencing based in vitro diagnostic test that uses amplicon-based target enrichment technology for detection of single nucleotide variants (SNVs) and deletions in 2 genes from DNA isolated from formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) tumor tissue specimens. The test is intended as a companion diagnostic to identify patients with NSCLC or CRC who may benefit from treatment with the targeted therapies listed in Table 1 in accordance with the approved therapeutic product labeling. The O/RDx-LCCA is intended to be used on the Illumina MiSeqDx® instrument.Table 1. List of somatic variants for therapeutic useIndication Gene Variant Targeted therapyColorectal Cancer (CRC) KRAS KRAS wild-type (absence of mutations in codons 12 and 13) ERBITUX® (cetuximab), orVECTIBIX® (panitumumab)Non-Small Cell Lung Cancer(NSCLC) EGFR Exon 19 Deletions and Exon 21 L858R Substitution Mutations EGFR Tyrosine Kinase Inhibitors approved by FDA**For the most current information about the therapeutic products in this group, go to: https://www.fda.gov/medicaldevices/productsandmedicalprocedures/invitrodiagnostics/ucm301431.htm

    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