Ion Torrent Oncomine Comprehensive assays are members of the family of Oncomine assays for clinical cancer research.  Oncomine assays are multiple-biomarker next-generation sequencing (NGS)-based assays that have been adopted by leading cancer institutions around the world and used to profile thousands of samples in different translational and clinical research projects including the NCI MATCH trial, delivering consistently reliable results.

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 Download flyer with gene list comparison of Oncomine Comprehensive Assay v1 and v3 ›

Oncomine Comprehensive assays, based on Ion Ampliseq technology and enabled by the Ion Torrent platform, provide:

  • The most relevant content based on evidence from Oncomine Knowledgebase, one of the largest curated sets of evidence in oncology research, and collaboration with leading oncology research institutions as well as pharma companies
  • Multiple biomarker type analysis including hotspot SNVs, indels, CNVs, and gene fusions across a range of cancer types
  • Proven and reliable performance with high specificity, sensitivity, and reproducibility across different research laboratories, enabled by the robust design and enhanced manufacturing quality of reagents in our ISO13485-compliant facility, including enhanced QC
  • Robust results from even those challenging FFPE tissue samples, including FNAs, with sample input as low as 10 ngs of DNA and RNA
  • Efficient workflow on Ion Chef and Ion S5 systems with high multiplexing flexibility and fast time to results
  • Enhanced bioinformatics and reporting solutions developed for the Ion Torrent platform and optimized Oncomine assays, including Oncomine Knowledgebase Reporter, enabling contextual investigation of sample-specific variants to understand their relevance in the latest oncology research and use with respect to labels, guidelines, and current global clinical trials


Oncomine Comprehensive assays content

The content is based on the latest scientific and clinical research evidence and in collaboration with key academic institutions and pharma companies.

The Oncomine Comprehensive Assay v3, launched in May 2017, has expanded:

  • 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


Oncomine Comprehensive assays performance

 

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.


Oncomine comprehensive assays workflow

The streamlined workflow is flexible, enabling use of different platfoms and throughput. The Oncomine Comprehensive Assay v3 has been optimized for throughput of 8 samples on the Ion S5 System, with automated library preparation using the Ion Chef System. The assay is available 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.

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