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    TEST:
    Oncomine Precision Assay

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

    News

    2d
    Successful simplified genomic profiling of cytology specimens using Aspyre Clinical Test for Lung (Tissue). (PubMed, Cancer Cytopathol)
    Aspyre Clinical Test for Lung performs effectively on samples derived from fine needle aspirate rinses and pleural fluid. Using these cytology-based specimens for biomarker testing enables pathologists to perform simplified genomic profiling while preserving valuable tissue specimens, potentially reducing the need for additional invasive procedures.
    Journal
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    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • MET (MET proto-oncogene, receptor tyrosine kinase)
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    EGFR exon 20 insertion • MET exon 14 mutation • EGFR exon 20 mutation
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    Aspyre® Lung • Oncomine Precision Assay
    12d
    Rapid On-Site Next-Generation Sequencing: An Alternative to Single-Gene and Send-Out Testing in Non-Small Cell Lung Cancer and Colorectal Cancer in a Community Pathology Laboratory Setting. (PubMed, J Mol Diagn)
    In CRC, TAT was 4.1, 5.3, and 10.2; QNS 0%, 0%, 7.5%; detection 63.9%, 62.5%, and 57.1%. OPA provides faster TAT and lower QNS rates with comparable detection of actionable alterations, supporting its use for community-based molecular testing in NSCLC and CRC.
    Journal • 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) • NRAS (Neuroblastoma RAS viral oncogene homolog) • 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)
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    KRAS mutation • KRAS G12C • BRAF mutation • HER-2 amplification • HER-2 mutation • RET fusion • MET exon 14 mutation • ALK fusion • ALK mutation • ROS1 fusion • KRAS G12
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    Oncomine Precision Assay
    4ms
    Liquid Biopsy Genotyping Using Oncomine Precision Assay GX in Advanced NSCLC (clinicaltrials.gov)
    P=N/A, N=22, Completed, Institute of Oncology Ljubljana
    New trial • Liquid biopsy • Circulating tumor DNA
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    Oncomine Precision Assay
    5ms
    Liquid Biopsy and Automated Next-Generation Sequencing: Achieving Results in 27 Hours Within a Community Setting. (PubMed, Diagnostics (Basel))
    This report demonstrates that fully automated cfDNA-based NGS can achieve clinically meaningful genomic profiling within 27 h in a community hospital. This advancement addresses the time and cost barriers of traditional NGS analysis and represents a significant step toward promoting precision medicine in community healthcare.
    Journal • Liquid biopsy • Next-generation sequencing
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    KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • GNA11 (G Protein Subunit Alpha 11)
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    TP53 mutation • KRAS mutation • PIK3CA mutation • KRAS G12R • KRAS G12
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    Oncomine Precision Assay
    6ms
    Dideoxy sequencing enhances detection of KIT mutations in GISTs initially evaluated by NGS hotspot panels. (PubMed, J Mol Diagn)
    Mutations were 12 to 39 nucleotide deletion or duplication variants. Our results suggest that short read, amplicon-based NGS assays may miss a significant number of clinically actionable KIT mutations and that follow-up of KIT and PDGFRA NGS-negative cases by alternative testing modalities should be considered.
    Journal • Next-generation sequencing
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    KIT (KIT proto-oncogene, receptor tyrosine kinase) • PDGFRA (Platelet Derived Growth Factor Receptor Alpha)
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    KIT mutation • KIT positive • PDGFRA mutation
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    Ion AmpliSeq™ Cancer Hotspot Panel v2 • Oncomine Precision Assay
    7ms
    Translating genomic insights into therapy: an NGS-based mutation profiling study in breast cancer. (PubMed, Med Oncol)
    The noteworthy observation is out of 7 Triple Negative Breast Cancer patients three patients were negative for any mutation. Hence, the association of genetic variation with clinicopathological parameters will be helpful in the selection of targeted treatment.
    Journal • Next-generation sequencing
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    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • FGFR (Fibroblast Growth Factor Receptor)
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    TP53 mutation • EGFR mutation • PIK3CA mutation • PTEN mutation • FGFR mutation
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    Oncomine Precision Assay
    8ms
    ESR1 analysis of liquid biopsy in breast cancer, one-year routine experience of an Italian clinical referral center. (PubMed, J Liq Biopsy)
    ESR1 mutations are detectable in approximately one-third of ER+/HER2- metastatic patients undergoing liquid biopsy. NGS platforms allow for sensitive and in-depth analysis, highlighting co-mutations of potential clinical and therapeutic relevance.
    Journal • Liquid biopsy
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
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    TP53 mutation • ER positive • HER-2 negative • PIK3CA mutation • ESR1 mutation
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    Oncomine Precision Assay • Oncomine™ Breast cfDNA Assay
    10ms
    MTAP expression by immunohistochemistry: a novel biomarker in non-small cell cancer of the lung. (PubMed, J Thorac Oncol)
    MTAP IHC seems to be better suited than OPA-NGS to assess the MTAP status in NSCLC, especially as the MTAP gene is not specifically covered within this panel. CDKN2A loss is not a reliable MTAP loss surrogate, as it overestimated MTAP loss in more than 25% of the cases in the TCGA cohort.
    Journal
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    CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • MTAP (Methylthioadenosine Phosphorylase)
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    Oncomine Precision Assay
    10ms
    Implementation of circulating tumor DNA (ctDNA) testing in precision oncology: A four-year experience from a tertiary cancer center in India. (PubMed, J Liq Biopsy)
    The comparison revealed high concordance, clinical relevance, and reliability of liquid biopsy-based genomic profiling in diverse oncologic settings. Study underscores substantial increase in the adoption of liquid biopsy and the real-world utility of ctDNA-based NGS testing in solid tumors contributing to improved patient care management.
    Journal • Circulating tumor DNA
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    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • CHEK2 (Checkpoint kinase 2)
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    TP53 mutation • KRAS mutation • EGFR mutation • BRAF mutation • PIK3CA mutation
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    Oncomine Precision Assay
    12ms
    Circulating tumor DNA profiling for non-invasive genomic analysis in Indian lung cancer patients: A real-world experience. (PubMed, J Liq Biopsy)
    The ctDNA assay demonstrates high accuracy and specificity, for both prevalent and rare genetic alterations. While further advancements are needed to enhance sensitivity and routine clinical application, our ctDNA profiling assay offers a reliable alternative for detecting genetic alterations in lung cancer patients, with significant potential for clinical integration in the Indian healthcare context.
    Journal • Real-world evidence • Circulating tumor DNA
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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) • TP53 (Tumor protein P53)
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    TP53 mutation • EGFR mutation
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    Oncomine Precision Assay
    1year
    Prevalence of EGFR gene mutations in patients with early-stage resectable non-small cell lung cancer in Spain: the ORIGEN study. (PubMed, Transl Lung Cancer Res)
    The prevalence of EGFR mutations in early stage (IA-IIIB), resectable, non-squamous NSCLC observed in our study is consistent with that reported in advanced NSCLC in Spain. Molecular testing is crucial in early-stage NSCLC and can be performed either with single-gene testing or NGS.
    Journal
    |
    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) • TP53 (Tumor protein P53) • PTEN (Phosphatase and tensin homolog) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A)
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    TP53 mutation • BRAF V600E • KRAS mutation • EGFR mutation • KRAS G12C • BRAF V600 • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • ATM mutation • PTEN mutation • ROS1 fusion • KRAS G12
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    Idylla™ EGFR Mutation Test • Oncomine Precision Assay
    1year
    Identification of Driver Mutations and Risk Stratification in Lung Adenocarcinoma via Liquid Biopsy. (PubMed, Cancers (Basel))
    Liquid biopsy holds promise for identifying high-risk lung adenocarcinoma cases and serves as a complementary diagnostic tool in advanced stages, enhancing disease management strategies.
    Journal • Liquid biopsy
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    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase)
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    KRAS mutation
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    Oncomine Precision Assay