BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

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

    PMA: P210040 · Decision Dec 12, 2022
    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
    RESOLUTION ctDx FIRST
    PMA Number
    P210040
    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    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    December 12, 2022
    Date Received
    December 28, 2021
    Expedited Review
    N
    Docket Number
    22M-3219

    Advisory Committee Statement

    Approval for the Agilent Resolution ctDx FIRST assay. The device is a qualitative next generation sequencing-based, in vitro diagnostic test that uses targeted hybrid-capture sequencing technology to detect and report single nucleotide variants (SNVs) and deletions in two genes. The Agilent Resolution ctDx FIRST assay utilizes circulating cell-free DNA (cfDNA) isolated from plasma of peripheral whole blood collected in Streck Cell-Free DNA Blood Collection Tubes (BCTs). The test is intended as a companion diagnostic to identify patients with non-small cell lung cancer (NSCLC) who may benefit from treatment with the targeted therapy listed in Table 1, in accordance with the approved therapeutic labeling.Table 1. Companion Diagnostic IndicationIndication: Non-small cell lung cancer (NSCLC); Biomarker: KRAS G12C; Therapy: KRAZATI (adagrasib) A negative result from a plasma specimen does not assure that the patient’s tumor is negative for genomic findings. Patients with NSCLC who are negative for the biomarker listed in Table 1 should be reflexed to tissue biopsy testing for Table 1 biomarker using an FDA-approved tumor tissue test, if feasible.Additionally, the test is intended to provide tumor mutation profiling for SNVs and deletions in the EGFR gene for use by qualified health care professionals in accordance with professional guidelines in oncology for patients with NSCLC. The test is for use with patients previously diagnosed with NSCLC and in conjunction with other laboratory and clinical findings.Genomic findings other than those listed in Table 1 are not prescriptive or conclusive for labeled use of any specific therapeutic product.The Agilent Resolution ctDx FIRST assay is a single-site assay performed at Resolution Bioscience, Inc.

    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