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    TEST:
    Oncomine Myeloid Assay GX

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

    News

    8ms
    A comparison of sequential polymerase chain reaction-based cascade testing vs next-generation sequencing in molecular profiling of myeloproliferative neoplasms: improving testing strategies in light of evolving molecular landscapes. (PubMed, Lab Med)
    Next-generation sequencing provides comprehensive molecular profiling in patients with MPNs, identifying additional prognostic and therapeutic markers. However, PCR remains superior for detecting low-variant allele frequency variants. We propose an updated MPN testing strategy that integrates PCR and NGS within a reflex algorithm to optimize diagnostics and therapeutic guidance.
    Journal • Next-generation sequencing • Polymerase Chain Reaction
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    ABL1 (ABL proto-oncogene 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • DNMT3A (DNA methyltransferase 1) • JAK2 (Janus kinase 2) • SF3B1 (Splicing Factor 3b Subunit 1) • TET2 (Tet Methylcytosine Dioxygenase 2) • CALR (Calreticulin)
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    SF3B1 mutation
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    Oncomine Myeloid Assay GX
    1year
    DNA and RNA NGS for Myeloid Neoplasms Using Oncomine Myeloid Assay GX v2 on GeneXus: An Assessment of Clinical Utility (AMP 2024)
    This DNA- and RNA-based 80-gene panel has proven to be a powerful tool for genomic profiling of myeloid neoplasms. The results were provided to hematopathologists/oncologists in timely fashion with the critical information for diagnosis confirmation, and disease classification, as well as assessment of patient response to treatment.
    Clinical • Next-generation sequencing
    |
    KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • FLT3 (Fms-related tyrosine kinase 3) • NRAS (Neuroblastoma RAS viral oncogene homolog) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • NPM1 (Nucleophosmin 1) • DNMT3A (DNA methyltransferase 1) • JAK2 (Janus kinase 2) • RUNX1 (RUNX Family Transcription Factor 1) • SF3B1 (Splicing Factor 3b Subunit 1) • ASXL1 (ASXL Transcriptional Regulator 1) • KMT2A (Lysine Methyltransferase 2A) • TET2 (Tet Methylcytosine Dioxygenase 2) • PTPN11 (Protein Tyrosine Phosphatase Non-Receptor Type 11) • SRSF2 (Serine and arginine rich splicing factor 2) • BCOR (BCL6 Corepressor) • U2AF1 (U2 Small Nuclear RNA Auxiliary Factor 1) • CEBPA (CCAAT Enhancer Binding Protein Alpha) • STAG2 (Stromal Antigen 2) • DDX41 (DEAD-Box Helicase 41) • CALR (Calreticulin) • ZRSR2 (Zinc Finger CCCH-Type, RNA Binding Motif And Serine/Arginine Rich 2)
    |
    FLT3-ITD mutation • NPM1 mutation • U2AF1 mutation • CEBPA mutation • JAK2 V617F
    |
    Oncomine Myeloid Assay GX
    1year
    Detection of Chronic Myeloid Leukemia Resistance with DNA Sequencing from Dried Blood Spots (AMP 2024)
    This project highlights the application of creative and robust methods of molecular diagnostics for LMICs, allowing for the treatment and monitoring of patients with previously limited access to assays and medications widely available in Western industrialized countries.
    ABL1 (ABL proto-oncogene 1)
    |
    ABL1 T315I • ABL1 Y253H
    |
    Oncomine Myeloid Assay GX
    1year
    Rapid and Accurate Detection of Myeloid Malignancy Mutations Using the Oncomine Myeloid Assay Gx V2 on the GeneXus System (AMP 2024)
    With the applied filters and cutoffs established during the validation, the Oncomine Myeloid V.2 assay performed on the GeneXus System provides a rapid, accurate, and reliable method for detecting actionable mutations in myeloid malignancies. Its high performance, coupled with a short turnaround time and compatibility with low input material, supports its utility in clinical practice for guiding personalized treatment decisions.
    FLT3 (Fms-related tyrosine kinase 3)
    |
    Oncomine Myeloid Assay GX
    over1year
    Association between B Cell Marker Expression and RUNX1 Lesions in Acute Myeloid Leukemia, beyond RUNX1 ::RUNX1T1 Fusion: Diagnostic Pitfalls with Mixed-Phenotype Acute Leukemia-B/Myeloid (AMP Europe 2024)
    All cases fulfilled criteria of MPAL-B/myeloid (i.e., ≥20% blasts expressing B and myeloid lineage antigens); however, detection of myelodysplasia-related genetic aberrations in 3 cases and history of cytotoxic therapy in the fourth case superseded the immunophenotypic features. Our findings suggest that various RUNX1 aberrations may impart an MPAL-like phenotype in AML that otherwise fulfil criteria for genetically defined subtypes of a myeloid malignancy.
    TP53 (Tumor protein P53) • CD19 (CD19 Molecule) • RUNX1 (RUNX Family Transcription Factor 1) • RUNX1T1 (RUNX1 Partner Transcriptional Co-Repressor 1) • CD22 (CD22 Molecule) • PAX5 (Paired Box 5) • CD79A (CD79a Molecule) • CBFA2T3 (CBFA2/RUNX1 Partner Transcriptional Co-Repressor 3)
    |
    Oncomine Myeloid Assay GX
    over1year
    Clinical validation of the Ion Torrent Oncomine Myeloid Assay GX v2 on the Genexus Integrated Sequencer as a stand-alone assay for single-nucleotide variants, insertions/deletions, and fusion genes: Challenges, performance, and perspectives. (PubMed, Am J Clin Pathol)
    This extensive clinical validation of the Oncomine Myeloid Assay GX v2 on the Genexus Integrated Sequencer with its built-in bioinformatics pipeline and Ion Torrent Oncomine Reporter shows robust performance in terms of variant calling accuracy, precision, and reproducibility, with the advantage of a rapid turnaround time of 2 days. The greatest limitation is the inability to detect variants in long homopolymer regions.
    Journal
    |
    Oncomine Myeloid Assay GX
    almost2years
    Detection of KMT2A-PTDs and KMT2A fusions using next generation sequencing (AACR 2024)
    We characterize the KMT2A fusions present in myeloid malignant samples. We also describe the abundance of KMT2A PTDs in both healthy donor and myeloid samples, with myeloid cases showing significantly higher PTD read counts. KMT2A PTD read count >2000 is present only in malignant samples but not in healthy donors.
    Next-generation sequencing
    |
    KMT2A (Lysine Methyltransferase 2A) • MLLT3 (MLLT3 Super Elongation Complex Subunit)
    |
    MLL rearrangement • MLL rearrangement • KMT2A-PTD • MLL fusion
    |
    Oncomine Myeloid Assay GX
    almost2years
    A comprehensive genomic profiling of myeloid malignancies demonstrates mutational spectrum of DNA variants, FLT3-ITDs, and gene fusions (AACR 2024)
    The Oncomine Myeloid Assay is a fast, robust, and reproducible solution for comprehensive genomic profiling of myeloid malignancies. We describe the mutational spectrum of DNA variants and RNA fusions in a range of clinical research samples. (For research use only.
    TP53 (Tumor protein P53) • FLT3 (Fms-related tyrosine kinase 3) • ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • FGFR1 (Fibroblast growth factor receptor 1) • DNMT3A (DNA methyltransferase 1) • MYD88 (MYD88 Innate Immune Signal Transduction Adaptor) • RUNX1 (RUNX Family Transcription Factor 1) • ASXL1 (ASXL Transcriptional Regulator 1) • KMT2A (Lysine Methyltransferase 2A) • TET2 (Tet Methylcytosine Dioxygenase 2) • SRSF2 (Serine and arginine rich splicing factor 2) • CREBBP (CREB binding protein) • CEBPA (CCAAT Enhancer Binding Protein Alpha) • ZMYM2 (Zinc Finger MYM-Type Containing 2) • CALR (Calreticulin) • KAT6A (Lysine Acetyltransferase 6A) • ANKRD26 (Ankyrin Repeat Domain Containing 26)
    |
    FLT3-ITD mutation • ASXL1 mutation • TET2 mutation • SRSF2 mutation • FGFR1 fusion
    |
    Oncomine Myeloid Assay GX • Oncomine Myeloid Research Assay
    almost2years
    Evaluation of Percentage of p53-Positive Dark Cells and Inter-Rater Reliability in Cases of TP53-Positive Myeloid Neoplasms: A Single Academic Institution Experience (USCAP 2024)
    P53 IHC in BM has good to excellent interobserver reproducibility. IHC evaluation of p53 shows high sensitivity and specificity for TP53ms; further work validating cutoffs in specific disease entities is ongoing. A high negative predictive value could be helpful as a biomarker for real-time stratification based on TP53m+ status.
    Clinical
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation
    |
    Oncomine Myeloid Assay GX
    almost2years
    Performing NGS Testing for Myeloid Malignancies in an Academic Medical Center Improves Turnaround Time and Cost (ACMG 2024)
    Our experience demonstrates that a successful NGS-based testing program can be developed and executed within an academic medical center setting with quality, price, and TATs that are competitive with large commercial reference laboratories. The ability to implement NGS testing in smaller clinical settings continues to make the promise of personalized medicine more accessible to the patients that need it.
    Next-generation sequencing
    |
    Oncomine Myeloid Assay GX
    2years
    A Comprehensive Genomic Profiling of Myeloid Malignancies Demonstrates Mutational Spectrum of DNA Variants Including FLT3-ITDs, and Gene Fusions (ASH 2023)
    "Not for use in diagnostic procedures. )"
    TP53 (Tumor protein P53) • FLT3 (Fms-related tyrosine kinase 3) • ABL1 (ABL proto-oncogene 1) • NRAS (Neuroblastoma RAS viral oncogene homolog) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • FGFR1 (Fibroblast growth factor receptor 1) • NPM1 (Nucleophosmin 1) • DNMT3A (DNA methyltransferase 1) • JAK2 (Janus kinase 2) • MYD88 (MYD88 Innate Immune Signal Transduction Adaptor) • RUNX1 (RUNX Family Transcription Factor 1) • SF3B1 (Splicing Factor 3b Subunit 1) • ASXL1 (ASXL Transcriptional Regulator 1) • KMT2A (Lysine Methyltransferase 2A) • TET2 (Tet Methylcytosine Dioxygenase 2) • SRSF2 (Serine and arginine rich splicing factor 2) • CREBBP (CREB binding protein) • RUNX1T1 (RUNX1 Partner Transcriptional Co-Repressor 1) • BCOR (BCL6 Corepressor) • PML (Promyelocytic Leukemia) • CEBPA (CCAAT Enhancer Binding Protein Alpha) • CALR (Calreticulin) • KAT6A (Lysine Acetyltransferase 6A) • MLLT3 (MLLT3 Super Elongation Complex Subunit) • ANKRD26 (Ankyrin Repeat Domain Containing 26)
    |
    FLT3-ITD mutation • TET2 mutation • FGFR1 fusion
    |
    Oncomine Myeloid Assay GX • Oncomine Myeloid Research Assay
    2years
    Detection of KMT2A Partial Tandem Duplications ( KMT2A-PTDs) in Healthy Donors Using Next Generation Sequencing (ASH 2023)
    "Not for use in diagnostic procedures. )"
    Clinical
    |
    KMT2A (Lysine Methyltransferase 2A)
    |
    KMT2A-PTD • MLL fusion • MLL-PTD
    |
    Oncomine Myeloid Assay GX