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    TEST:
    Oncomine Focus Assay

    Company:
    Thermo Fisher Scientific
    Type:
    Laboratory Developed Test
    Related tests:
    Details
    Evidence

    News

    8d
    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
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    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
    6ms
    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
    6ms
    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
    7ms
    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)
    7ms
    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
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    Oncomine Focus Assay
    8ms
    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
    12ms
    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
    12ms
    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
    1year
    Negative hyperselection and mechanisms of acquired resistance to first-line chemotherapy plus anti-EGFR in pMMR RAS/BRAF wild-type (wt) metastatic colorectal cancer (mCRC) patients (pts): a translational analysis of the TRIPLETE trial (AIOM 2024)
    TRIPLETE is a phase III trial where 435 pts with RAS/BRAF wt – per local assessment – mCRC were randomized to receive first-line FOLFOX/ panitumumab (pan) or mFOLFOXIRI/pan... In contrast to previous data, negative hyperselection both through tissue and plasma analysis failed to demonstrate a prognostic role among pMMR RAS/BRAF wt mCRC pts treated with first-line chemotherapy plus pan. The confounding effect of the associated chemotherapy is a potential explanation for this finding. Tissue and plasma analyses at baseline failed to provide fully concordant results.
    Clinical • Preclinical • Metastases
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    BRAF (B-raf proto-oncogene) • MAP2K1 (Mitogen-activated protein kinase kinase 1)
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    BRAF V600E • MSI-H/dMMR • BRAF V600 • BRAF wild-type • RAS mutation • RAS wild-type
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    FoundationOne® CDx • Oncomine™ Pan-Cancer Cell-Free Assay • Oncomine Focus Assay
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    5-fluorouracil • Vectibix (panitumumab) • leucovorin calcium
    1year
    Comparison of Clinical Sensitivity for Kinase Fusion Detection in Thyroid Carcinoma by Paired Primer Targeted Methods (AMP 2024)
    AFP, the targeted, breakpoint/fusion partner agnostic panel, outperformed 3 other established panels using real-world, fusion-driven thyroid cancers by an average detection frequency of 39%. Such findings demonstrate the importance in sequencing panel selection for fusion-driven thyroid cancer detection, and the potential downstream consequences for diagnostic utility and therapeutic intervention.
    Clinical
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    BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • RET (Ret Proto-Oncogene) • FGFR2 (Fibroblast growth factor receptor 2) • 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)
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    NTRK1 fusion • FGFR2 fusion • ALK fusion
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    FusionPlex® Dx • Illumina Focus Panel • Oncomine Focus Assay
    1year
    COMPREHENSIVE GENOMIC PROFILING OF PATIENTS DIAGNOSED WITH SARCOMA IN BRAZIL: MOLECULAR PROFILE AND ACTIONABILITY (CTOS 2024)
    To the best of our knowledge, we provide the largest single-institution analysis of CGP in sarcoma in Latin America. Our study identified actionable alterations in 35% of tumor samples of 85 patients diagnosed with sarcoma submitted to CGP. A high level of evidence of clinical activity according to OncoKB criteria was noted in 17% of actionable alterations.
    Clinical • Tumor mutational burden • MSi-H Biomarker
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    TP53 (Tumor protein P53) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • RB1 (RB Transcriptional Corepressor 1)
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    MSI-H/dMMR
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    TruSight Oncology 500 Assay • Oncomine Focus Assay
    1year
    Integrating Genetic Alterations and Histopathological Features for Enhanced Risk Stratification in Non-Muscle-Invasive Bladder Cancer. (PubMed)
    In multivariate Cox regression, MAI was the strongest predictor for PFS. Integrating genetic alterations and histopathological features may improve risk stratification in NMIBC.
    Journal
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    Oncomine Focus Assay