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    TEST:
    Oncomine Focus Assay

    Company:
    Thermo Fisher Scientific
    Type:
    Research Use Only
    Related tests:
    Details
    Evidence

    News

    7d
    Retrospective Comparison of Operational Metrics Across Diagnostic Approaches for Molecular Testing in Lung and Colon Cancers in a Community-Based Setting. (PubMed, Arch Pathol Lab Med)
    OFA balances TAT, QNS, and detection, whereas SO-NGS offers comprehensive detection with longer TAT and higher QNS. An optimized assay combining SGP's speed, OFA's reliability, and SO-NGS's comprehensiveness could improve outcomes.
    Retrospective data • Journal
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    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • NRAS (Neuroblastoma RAS viral oncogene homolog) • MSI (Microsatellite instability) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2) • TYK2 (Tyrosine Kinase 2) • NTRK (Neurotrophic receptor tyrosine kinase)
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    KRAS G12C • HER-2 amplification • HER-2 mutation • MET exon 14 mutation • KRAS G12 • KRAS amplification • NRAS G12
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    Oncomine Focus Assay
    8d
    Genomic Profile of Non-Small Cell Lung Cancer in a Spanish Cohort: A 2-Year Descriptive Study Using Next-Generation Sequencing. (PubMed, Genes (Basel))
    Our real-world data confirm the feasibility and clinical value of routine NGS testing for NSCLC. The findings highlight specific genomic patterns in this population and demonstrate that smoking status should not preclude comprehensive molecular testing for canonical drivers.
    Journal • Next-generation sequencing
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    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • TP53 (Tumor protein P53)
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    EGFR mutation • KRAS G12C • ALK fusion • KRAS G12
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    Oncomine Focus Assay
    16d
    Synonymous Variants of Potential Significance Identified by a 52-Gene Clinical Sequencing Panel in Non-Small Cell Lung Cancer. (PubMed, Genes Chromosomes Cancer)
    This cohort demonstrates both expected and distinct genomic features, including novel synonymous variants in oncogenic pathways. These findings suggest regional variation in NSCLC genomics and support further study of synonymous variants in disease progression.
    Journal
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    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • NRAS (Neuroblastoma RAS viral oncogene homolog) • FGFR2 (Fibroblast growth factor receptor 2) • FGFR3 (Fibroblast growth factor receptor 3) • NF1 (Neurofibromin 1)
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    Oncomine Focus Assay
    2ms
    MGDB: A Novel Bioinformatics Quality Control Tool for Clinical Next-Generation Sequencing. (PubMed, Cancer Inform)
    MGDB offers a robust and user-friendly solution for enhancing quality control in clinical NGS workflows, contributing to greater accuracy and reliability in variant detection. The tool is freely available on GitHub: https://github.com/acri-nb/GeneticVariantsDB.
    Journal • Next-generation sequencing
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    Oncomine Focus Assay
    3ms
    Comprehensive Molecular Diagnostic Tests in Non-Small Cell Lung Cancer: Frequency of ALK, ROS1, RET, and Other Gene Fusions/Rearrangements in a Romanian Cohort. (PubMed, Cancers (Basel))
    These alterations were mutually exclusive with common drivers such as EGFR or KRAS. Detection of rare fusions highlights the therapeutic potential of comprehensive NGS profiling in Romanian NSCLC patients.
    Journal
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • FGFR3 (Fibroblast growth factor receptor 3) • EML4 (EMAP Like 4) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2) • CD74 (CD74 Molecule) • TACC3 (Transforming acidic coiled-coil containing protein 3) • ETV6 (ETS Variant Transcription Factor 6) • PTPRZ1 (Protein Tyrosine Phosphatase Receptor Type Z1)
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    EGFR mutation • EGFR L858R • ALK positive • RET fusion • ALK fusion • ROS1 fusion
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    Oncomine Focus Assay
    9ms
    Molecular Profiling Project (clinicaltrials.gov)
    P=N/A, N=500, Recruiting, National Cancer Centre, Singapore | Trial primary completion date: Dec 2024 --> Dec 2025
    Trial primary completion date
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    Oncomine™ Comprehensive Assay v3M • Oncomine Focus Assay
    9ms
    MaGenTA: Map of Tumor Genetic Actionability in Argentina (clinicaltrials.gov)
    P=N/A, N=100, Active, not recruiting, Hospital Italiano de Buenos Aires
    New trial
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    Oncomine Focus Assay
    10ms
    Liquid and tissue biopsies for identifying MET exon 14 skipping NSCLC: Analyses from the Phase II VISION study of tepotinib. (PubMed, Clin Cancer Res)
    Tepotinib had robust, durable activity in TBx-positive/LBx-negative and TBx-positive/LBx-positive patients. While LBx is a complementary method to TBx for detecting METex14, it may preferentially select patients with higher tumor burden and poorer prognosis. Undetectable METex14 in baseline ctDNA (due to low ctDNA shedding) may define more favorable treatment outcomes.
    P2 data • Journal
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    MET (MET proto-oncogene, receptor tyrosine kinase)
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    MET exon 14 mutation
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    Guardant360® CDx • ArcherMET • Oncomine Focus Assay
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    Tepmetko (tepotinib)
    10ms
    Comprehensive molecular profiling of advanced NSCLC using NGS: Prevalence of druggable mutations and clinical trial opportunities in the ATLAS study. (PubMed, Lung Cancer)
    The ATLAS study demonstrates the utility of comprehensive NGS testing, which detects clinically relevant mutations in more than one-third of patients and may extend therapy options.
    Journal • Next-generation sequencing
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    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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    BRAF V600E • KRAS mutation • EGFR mutation • KRAS G12C • BRAF V600 • MET amplification • RET fusion • MET exon 14 mutation • ROS1 fusion • MET mutation • KRAS G12 • ALK translocation
    |
    Oncomine Focus Assay
    11ms
    Real-world application of targeted next-generation sequencing for identifying molecular variants in Asian non-small-cell lung cancer. (PubMed, BMC Cancer)
    This study demonstrates the robust performance of the OFA in identifying clinically relevant genetic alterations in NSCLC. The findings support its clinical utility in precision oncology and provide valuable insights into the genetic landscape of Asian NSCLC, enhancing personalized treatment strategies for lung cancer patients.
    Journal • Real-world evidence • Next-generation sequencing
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    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1)
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    KRAS mutation • EGFR mutation • KRAS G12C • BRAF mutation • RET fusion • MET exon 14 mutation • ALK fusion • RET mutation • ROS1 fusion • MET mutation • KRAS G12
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    Oncomine Focus Assay
    1year
    Analytical Validation and Performance Evaluation of Amplicon-Based Next-Generation Sequencing Assays for Detecting ERBB2 and Other Gene Amplifications in Solid Tumors. (PubMed, Cancers (Basel))
    This study highlights the strengths and limitations of amplicon-based NGS assays in detecting amplifications using real-world data.
    Journal • Next-generation sequencing
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 amplification
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    Oncomine™ Comprehensive Assay v3M • Oncomine Focus Assay • Oncomine™ Comprehensive Assay Plus
    1year
    Targeted Sequencing in Rosai-Dorfman Disease from Microdissected Specimens Reveals Higher Incidence of MAP2K1 Mutations (ASH 2024)
    The incidence of MAP2K1 mutations was higher in the current study than in previous studies (Garces et al. 2017), though not statistically significant, at 29% (4/14) compared to 16% (8/49; p=0.15).These results highlight the value of stringent tissue microdissection for identifying targetable molecular alterations in RDD and suggest that such approaches may help uncover additional neoplastic drivers and/or mutations implicated in therapeutic resistance.
    KRAS (KRAS proto-oncogene GTPase) • MAP2K1 (Mitogen-activated protein kinase kinase 1)
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    KRAS mutation • KRAS G12D • KRAS G12 • MAP2K1 E203K • KRAS A146P • MAP2K1 G128D
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    Oncomine Focus Assay