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    TEST:
    OmniSeq INSIGHT

    Company:
    LabCorp
    Type:
    Other Approval
    Related tests:
    Details
    Evidence

    News

    2ms
    Labcorp announces new strategic service offerings within precision oncology portfolio (LabCorp Press Release)
    "Labcorp...announced new strategic service offerings within its precision oncology portfolio. This expansion will extend availability of the service through owned laboratories in Geneva and Shanghai to support research and investigational use in global clinical trials, streamlining access for patients to oncology clinical trials, broadening the patient population, and helping improve logistical efficiencies through Labcorp's global network."
    Clinical
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    OmniSeq INSIGHT • PGDx elio™ tissue complete assay
    3ms
    Poorly Differentiated Thyroid Cancer: A Rare Entity (ENDO 2024)
    Tyrosine kinase inhibitors i.e, sorafenib and lenvatinib, have been used in cases of progressive, recurrent, or metastatic disease not responsive to 131I therapy. PDTC accounts for 3–5% of all thyroid carcinomas. The 5, 10-, and 15-year survival rates of patients are 50–85%, 34–50%, and 0%, respectively. RAS gene alterations are found in 25–35%, BRAF mutation in 15–27%, TERT promoter mutation in 40% and mutant TP53 in 16–28% of PDTCs.
    PD(L)-1 Biomarker • BRCA Biomarker • IO biomarker
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    BRAF (B-raf proto-oncogene) • TP53 (Tumor protein P53) • BRCA1 (Breast cancer 1, early onset) • RET (Ret Proto-Oncogene) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2) • TERT (Telomerase Reverse Transcriptase) • NKX2-1 (NK2 Homeobox 1)
    |
    PD-L1 expression • TP53 mutation • BRAF V600E • BRCA1 mutation • NTRK1 fusion • NTRK3 fusion • NTRK2 fusion • RET fusion • RET mutation • TERT mutation • NTRK1 mutation • TERT promoter mutation • NTRK3 mutation
    |
    OmniSeq INSIGHT
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    sorafenib • Lenvima (lenvatinib)
    6ms
    Tissue genomic profiling of pleural mesothelioma patients treated with immunotherapy: Unraveling genetic alterations and complexity (ELCC 2024)
    Conclusions Our study did not identify predictive or prognostic factors for IO outcomes in unresectable PM, emphasizing the complexity and heterogeneity of PM. Further research with larger cohorts is crucial to unveil biomarkers in this setting.
    Clinical • Tumor mutational burden • IO biomarker
    |
    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • BAP1 (BRCA1 Associated Protein 1) • NF2 (Neurofibromin 2) • FANCA (FA Complementation Group A)
    |
    PIK3CA mutation • BAP1 mutation • NF2 mutation • FANCA mutation
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    FoundationOne® CDx • OmniSeq INSIGHT
    9ms
    Findings of clinically significant variants (Tier IA) with OmniSeq INSIGHT ® in a breast cancer cohort of 987 patients (SABCS 2023)
    CGIP for breast cancer patients identified one or more clinically significant Tier IA genomic alterations that directs targeted therapy in ~ 37.5% of patients in a cohort of real world patients tested during the standard course of clinical care. This highlights the need for comprehensive genomic testing in breast cancer patients to drive therapeutic decision making.
    Clinical • Tumor mutational burden • PD(L)-1 Biomarker • BRCA Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • MSI (Microsatellite instability) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • PALB2 (Partner and localizer of BRCA2)
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    PD-L1 expression • NTRK1 fusion • NTRK3 fusion
    |
    OmniSeq INSIGHT
    2years
    Labcorp expands access to comprehensive genomic testing through new lung cancer program (LabCorp Press Release)
    "Labcorp...is announcing a new sponsored testing program aimed at helping advanced non-small cell lung (NSCLC) cancer patients and their physicians make informed treatment and care management decisions through comprehensive genomic insights...The program will use Labcorp’s OmniSeq INSIGHTSM test, a pan-cancer, tissue-based sequencing test, to provide comprehensive genomic and immune profiling for cases that meet eligibility criteria."
    Clinical
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    OmniSeq INSIGHT
    over2years
    GenomOncology Pathology Workbench to Support OmniSeq INSIGHT, a Genomic and Immune Profiling Test That Identifies Potential Treatment and Clinical Trial Options for Solid Tumors (PRNewswire)
    "GenomOncology announced today that GenomOncology (GO) Pathology Workbench has been selected by Labcorp's OmniSeq to support the analysis and reporting of OmniSeq INSIGHT℠, a comprehensive genomic and immune profiling test for solid tumors....OmniSeq INSIGHT examines the full coding region of 523 genes by next generation sequencing for mutations, copy number alterations, fusions microsatellite instability (MSI), tumor mutation burden (TMB), and expression of 64 immune genes in the tumor microenvironment. The test also includes PD-L1 by immunohistochemistry."
    Clinical
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    OmniSeq INSIGHT
    3years
    OmniSeq receives New York State approval for cancer genomic, immune profiling test (OmniSeq Press Release)
    "OmniSeq said on Tuesday that it has received approval from the New York State Department of Health's Clinical Laboratory Evaluation Program for its Insight cancer genomic and immune profiling test...With the approval, the test, which detects genomic variants, genomic signatures, and immune gene expression to inform cancer treatment decisions, will be available to patients in New York."
    Regulatory
    |
    OmniSeq INSIGHT