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    TEST:
    OncoGuide™ NCC Oncopanel System

    Company:
    Sysmex Corp
    Type:
    Other Approval
    Related tests:
    Details
    Evidence

    News

    8d
    Clinical Utility of Comprehensive Genomic Profiling for Advanced Non-Small Cell Lung Cancer: A Single-Center Retrospective Study. (PubMed, Thorac Cancer)
    CGP testing can identify actionable mutations missed by conventional diagnostics and may provide additional therapeutic opportunities in NSCLC.
    Retrospective data • Journal
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    EGFR (Epidermal growth factor receptor)
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    EGFR mutation
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    FoundationOne® Liquid CDx • OncoGuide™ NCC Oncopanel System
    14d
    Pembrolizumab for MSI-high/TMB-high bone and soft tissue sarcomas: a retrospective single-institution study. (PubMed, Front Oncol)
    Comprehensive genomic profiling should be considered in refractory cases. Further studies are warranted to validate these results and explore additional biomarkers.
    Retrospective data • Journal • Tumor mutational burden • MSi-H Biomarker • PD(L)-1 Biomarker • IO biomarker • MSI-H
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    TMB (Tumor Mutational Burden) • MSI (Microsatellite instability)
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    TMB-H • MSI-H/dMMR
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    OncoGuide™ NCC Oncopanel System
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    Keytruda (pembrolizumab)
    14d
    Differences Among Genomic Profiling Tests for Bone and Soft-Tissue Sarcomas in a Universal Health Insurance System. (PubMed, J Bone Joint Surg Am)
    In this cohort, the DNA+RNA-based panel showed a higher detection rate for TK fusions, although the panels were applied to different patient groups and the sensitivity and specificity could not be determined. Future studies evaluating different test types on the same tumor specimens are warranted to clarify whether the dual-sequencing approaches can improve the identification of actionable genetic events.
    Reimbursement • US reimbursement • Journal
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    BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • EML4 (EMAP Like 4) • FGFR1 (Fibroblast growth factor receptor 1) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2) • NTRK (Neurotrophic receptor tyrosine kinase) • RBPMS (RNA-binding protein with multiple splicing)
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    ALK fusion • NTRK fusion
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    FoundationOne® CDx • OncoGuide™ NCC Oncopanel System
    |
    Vitrakvi (larotrectinib) • Rozlytrek (entrectinib)
    17d
    Adrenocortical Carcinoma in Peutz-Jeghers Syndrome With a Rare STK11 Pathogenic Germline Variant: A Case Report. (PubMed, Cancer Rep (Hoboken))
    This is the second report of ACC associated PJS in a rare germline variant of STK11. Although rare, loss of STK11 function may lead to cancers outside expected sites in PJS cases.
    Journal
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    STK11 (Serine/threonine kinase 11)
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    STK11 mutation
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    OncoGuide™ NCC Oncopanel System
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    cisplatin • doxorubicin hydrochloride • etoposide IV • Lysodren (mitotane)
    1m
    Feasibility of Comprehensive Genomic Profiling for Biliary Tract Cancer Using Transpapillary Biopsy Samples: A Prospective Study. (PubMed, J Hepatobiliary Pancreat Sci)
    Introducer-assisted multipass TPB may increase the rate of obtaining adequate CGP specimens, but its suitability remains limited and strongly panel dependent. Since FF samples have better DNA quality, establishing a system detailing their use is desirable.
    Journal
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    FoundationOne® CDx • OncoGuide™ NCC Oncopanel System
    2ms
    Tumor Cell Count and Total Cell Count as Surrogate Indicators of Comprehensive Genomic Profiling Success in Pancreatic Cancer Specimens Collected by Endoscopic Ultrasonography-Guided Tissue Acquisition. (PubMed, J Hepatobiliary Pancreat Sci)
    Tumor cell counts ≥ 2300 and total cell counts ≥ 6000 may serve as surrogate criteria for tissue area to determine EUS-TA specimen suitability for CGP in pancreatic cancer. Given that tumor cell count is a more biologically relevant indicator, total cell count should be used as a supplementary indicator.
    Journal
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    OncoGuide™ NCC Oncopanel System
    3ms
    Limited reliability of H3K27M detection using a commercially available blood-based comprehensive genomic profiling test in patients with diffuse midline gliomas: analysis of the nationwide C-CAT database in Japan. (PubMed, Int J Clin Oncol)
    Our findings indicate a critical limitation of F1 Liquid in detecting the H3K27M and other significant mutations in diffuse midline glioma.
    Journal
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    TP53 (Tumor protein P53) • PDGFRA (Platelet Derived Growth Factor Receptor Alpha) • NF1 (Neurofibromin 1)
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    IDH wild-type
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    FoundationOne® CDx • Guardant360® CDx • FoundationOne® Liquid CDx • OncoGuide™ NCC Oncopanel System
    3ms
    Real-world insights from comprehensive genomic profiling in patients with metastatic castration-resistant prostate cancer. (PubMed, Jpn J Clin Oncol)
    CGP identified BRCA PVs, MSI-high, or TMB-high in 20% of patients with metastatic CRPC, supporting its value in guiding precision oncology. However, only some patients received matched therapy, supporting earlier CGP testing. Routine integration of CGP may facilitate precision oncology-guided treatment decision-making in this population.
    Journal • Real-world evidence • Tumor mutational burden • BRCA Biomarker • MSi-H Biomarker • PD(L)-1 Biomarker
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    TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • BRCA (Breast cancer early onset)
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    TMB-H • MSI-H/dMMR
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    FoundationOne® Liquid CDx • OncoGuide™ NCC Oncopanel System
    |
    Keytruda (pembrolizumab)
    4ms
    Refining Tumor Mutational Burden as a Predictive Biomarker for Pembrolizumab: A Real-World Analysis in Japanese Patients. (PubMed, Cancer Sci)
    These findings support the clinical utility of TMB as a biomarker for predicting ICI response in routine oncology practice. In particular, excluding hotspot mutations from TMB calculations may improve response prediction in patients whose TMB values are near the threshold.
    Journal • Real-world evidence • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
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    TMB (Tumor Mutational Burden)
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    TMB-H • TMB-L
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    FoundationOne® CDx • OncoGuide™ NCC Oncopanel System
    |
    Keytruda (pembrolizumab)
    11ms
    Multi-Cancer Genome Profiling for Neurotrophic Tropomyosin Receptor Kinase (NTRK) Fusion Genes: Analysis of Profiling Database of 88,688 Tumors. (PubMed, Cancers (Basel))
    In contrast, the detection rates of the ALK and RET fusion genes were significantly higher in F1L. GMT, which is equipped with RNA sequencing analysis, might show a useful diagnostic ability for NTRK fusions, especially for NTRK2 fusion genes.
    Journal
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    ALK (Anaplastic lymphoma kinase) • RET (Ret Proto-Oncogene) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • FGFR3 (Fibroblast growth factor receptor 3) • FGFR1 (Fibroblast growth factor receptor 1) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2) • NTRK (Neurotrophic receptor tyrosine kinase)
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    RET fusion • NTRK fusion
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    FoundationOne® CDx • Guardant360® CDx • FoundationOne® Liquid CDx • OncoGuide™ NCC Oncopanel System
    12ms
    Comprehensive Genomic Profiling Testing for Castration-Resistant Prostate Cancer in Advanced Elderly Patients: A Single-Center Retrospective Cohort Study. (PubMed, Prostate)
    CGP testing appears to offer clinical benefits for patients with CRPC, regardless of age.
    Retrospective data • Journal
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    HRD (Homologous Recombination Deficiency)
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    FoundationOne® Liquid CDx • OncoGuide™ NCC Oncopanel System
    1year
    Factors associated with actionable gene aberrations in pancreatic cancer based on the C-CAT database. (PubMed, J Gastroenterol)
    Actionable gene aberrations were more likely in cases of ACC, KRASWT, and F1CDx usage. The choice of CGP test should be made on a case-by-case basis, as other factors beyond actionable gene aberrations also need to be considered.
    Journal • BRCA Biomarker
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    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • BRCA2 (Breast cancer 2, early onset)
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    KRAS mutation • KRAS wild-type • RAS wild-type
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    FoundationOne® CDx • OncoGuide™ NCC Oncopanel System