Oncomine Comprehensive Assay
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Oncomine Comprehensive Assay

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Conduct concurrent DNA and RNA NGS analysis from FFPE samples, targeting 143 cancer genes relevant to clinical cancer research. Detect SNVs, indels, CNVs, and fusions.

A comprehensive next-generation sequencing (NGS) assay for translational and early clinical research

The Oncomine Comprehensive Assay v3 is a multi-biomarker NGS assay that covers 161 of the most relevant cancer genes, based on the Oncomine Knowledgebase and from collaborations with leading cancer research institutions and pharmaceutical companies. The low sample input requirement enables the analysis of even small and challenging formalin-fixed paraffin-embedded (FFPE) samples.

Highlights of the Oncomine Comprehensive Assay v3 include:
  • Only 10 ng of DNA or RNA sample input, making the Oncomine Comprehensive Assay v3 an ideal solution for the analysis of challenging FFPE samples
  • Detects relevant SNVs, CNVs, gene fusions, and indels from 161 unique cancer-associated genes in one streamlined workflow
  • High specificity, sensitivity, and reproducibility across different research laboratories, as demonstrated in translational and clinical research projects including the NCI Match Trial
  • Efficient workflow on Ion Chef System plus Ion GeneStudio S5 or Ion Torrent Genexus system with high multiplexing flexibility and fast time to results

"The requirement of a lower DNA input for the Oncomine assay is a significant advantage when primary samples are becoming increasingly limited."

—John Bartlett, PhD

Director of Transformative Pathology Platform
Ontario Institute for Cancer Research

Oncomine Comprehensive Assay v3 gene content

The Oncomine Comprehensive Assay v3 includes:

  • Hotspot SNVs and indels, CNVs, and gene fusions
  • Kinase domain coverage to span the entire kinase domain in several critical receptor tyrosine kinases. This increases the likelihood of detecting functionally relevant mutations in addition to known actionable and prevalent variants (ALK, BRAF, DDR2, EGFR, ERBB2, KIT, MET, PDGFRA, RET, ROS1).
  • Representation of genes involved in DNA repair (31 genes in DNA repair pathway)
  • Coverage of MAPK, PI3K, and cell cycle pathway genes
  • 161 genes categorized by somatic alteration type
    87 Hotspots genes
    43 Focal CNV gains
    48 Full CDS for DEL mutations
    51 Fusion drivers
     

     

    To see the full gene content of the Oncomine Comprehensive Assay v3, download the flyer.


    Oncomine Comprehensive Assay v3 performance on Ion GeneStudio S5 sequencer

     

    True positive

    False positive

    False negative

    Sensitivity

    Positive predictive value

    Hotspots

    504

    9

    4

    99.21%

    98.25%

    Indels

    31

    0

    1

    96.88%

    100%

    DeNovo SNV

    602

    11

    18

    97.10%

    98.21%

    De novo InDel

    24

    2

    4

    85.71%

    92.31%

    Fusions

    82

    4

    4

    95.35%

    95.35%

    Table 1. The performance of the Oncomine Comprehensive Assay v3 has been verified using 20 FFPE cancer tissue samples and commercially available standard material from HorizonDx and SeraCare.


    Assay analytical validation—results of the NCI Match Trial

    Assay analytical validation--results of the NCI Match Trial
    Data adapted from: Lih CJ, et al. Analytical validation of the NGS assay for a nationwide signal-finding clinical trial molecular analysis for therapy choice clinical trial. J Mol Diagn. 2017 Mar;19(2):313-327.



    Flexible configurations to fit your needs

    The Oncomine Comprehensive Assay v3 has been optimized for throughput of eight samples on the Ion GeneStudio S5 Systems or six samples on the Ion Torrent Genexus System. The assay is available on Ion GeneStudio S5 Systems in two configurations: manual and automated (using Ion Chef System for library preparation) and includes the DNA and RNA primer panel and library preparation reagents. The Genexus System combines preparation, templating, and sequencing in one system.

    Ordering information
    For Ion GeneStudio S5 systems

    N.° de Catálogo
    Nombre
    Tamaño
    Precio (EUR)
    A35805 Oncomine™ Comprehensive Assay v3M 24 samples
    8.390,00
    A35806 Oncomine™ Comprehensive Assay v3C 32 samples
    12.630,00


    For Genexus System

    N.° de Catálogo
    Nombre
    Tamaño
    MSDS
    Documentos
    Precio (EUR)
    Cantidad
    A46296 Oncomine™ Comprehensive Assay v3 GX 16 samples
    Contáctenos ›
    -
    *Prices are subject to change of rate or promotion

    Description

    A comprehensive next-generation sequencing (NGS) assay for translational and early clinical research

    The Oncomine Comprehensive Assay v3 is a multi-biomarker NGS assay that covers 161 of the most relevant cancer genes, based on the Oncomine Knowledgebase and from collaborations with leading cancer research institutions and pharmaceutical companies. The low sample input requirement enables the analysis of even small and challenging formalin-fixed paraffin-embedded (FFPE) samples.

    Highlights of the Oncomine Comprehensive Assay v3 include:
    • Only 10 ng of DNA or RNA sample input, making the Oncomine Comprehensive Assay v3 an ideal solution for the analysis of challenging FFPE samples
    • Detects relevant SNVs, CNVs, gene fusions, and indels from 161 unique cancer-associated genes in one streamlined workflow
    • High specificity, sensitivity, and reproducibility across different research laboratories, as demonstrated in translational and clinical research projects including the NCI Match Trial
    • Efficient workflow on Ion Chef System plus Ion GeneStudio S5 or Ion Torrent Genexus system with high multiplexing flexibility and fast time to results

    "The requirement of a lower DNA input for the Oncomine assay is a significant advantage when primary samples are becoming increasingly limited."

    —John Bartlett, PhD

    Director of Transformative Pathology Platform
    Ontario Institute for Cancer Research

    Oncomine Comprehensive Assay v3 gene content

    The Oncomine Comprehensive Assay v3 includes:

  • Hotspot SNVs and indels, CNVs, and gene fusions
  • Kinase domain coverage to span the entire kinase domain in several critical receptor tyrosine kinases. This increases the likelihood of detecting functionally relevant mutations in addition to known actionable and prevalent variants (ALK, BRAF, DDR2, EGFR, ERBB2, KIT, MET, PDGFRA, RET, ROS1).
  • Representation of genes involved in DNA repair (31 genes in DNA repair pathway)
  • Coverage of MAPK, PI3K, and cell cycle pathway genes
  • 161 genes categorized by somatic alteration type
    87 Hotspots genes
    43 Focal CNV gains
    48 Full CDS for DEL mutations
    51 Fusion drivers
     

     

    To see the full gene content of the Oncomine Comprehensive Assay v3, download the flyer.


    Oncomine Comprehensive Assay v3 performance on Ion GeneStudio S5 sequencer

     

    True positive

    False positive

    False negative

    Sensitivity

    Positive predictive value

    Hotspots

    504

    9

    4

    99.21%

    98.25%

    Indels

    31

    0

    1

    96.88%

    100%

    DeNovo SNV

    602

    11

    18

    97.10%

    98.21%

    De novo InDel

    24

    2

    4

    85.71%

    92.31%

    Fusions

    82

    4

    4

    95.35%

    95.35%

    Table 1. The performance of the Oncomine Comprehensive Assay v3 has been verified using 20 FFPE cancer tissue samples and commercially available standard material from HorizonDx and SeraCare.


    Assay analytical validation—results of the NCI Match Trial

    Assay analytical validation--results of the NCI Match Trial
    Data adapted from: Lih CJ, et al. Analytical validation of the NGS assay for a nationwide signal-finding clinical trial molecular analysis for therapy choice clinical trial. J Mol Diagn. 2017 Mar;19(2):313-327.



    Flexible configurations to fit your needs

    The Oncomine Comprehensive Assay v3 has been optimized for throughput of eight samples on the Ion GeneStudio S5 Systems or six samples on the Ion Torrent Genexus System. The assay is available on Ion GeneStudio S5 Systems in two configurations: manual and automated (using Ion Chef System for library preparation) and includes the DNA and RNA primer panel and library preparation reagents. The Genexus System combines preparation, templating, and sequencing in one system.

    Ordering information
    For Ion GeneStudio S5 systems

    N.° de Catálogo
    Nombre
    Tamaño
    Precio (EUR)
    A35805 Oncomine™ Comprehensive Assay v3M 24 samples
    8.390,00
    A35806 Oncomine™ Comprehensive Assay v3C 32 samples
    12.630,00


    For Genexus System

    N.° de Catálogo
    Nombre
    Tamaño
    MSDS
    Documentos
    Precio (EUR)
    Cantidad
    A46296 Oncomine™ Comprehensive Assay v3 GX 16 samples
    Contáctenos ›
    -

    *Prices are subject to change of rate or promotion