oncominefocus

A solid tumor next-generation sequencing assay for biomarker analysis

The Oncomine™ Focus Assay is a targeted, multi-biomarker assay that enables you to target hotspots, SNVs, indels, CNVs, and gene fusions from DNA and RNA in a single workflow.

Designed for clinical and translational cancer research, the Oncomine Focus Assay leverages Ion AmpliSeq™ technology to enable robust results, low input amounts, and analysis of low quality samples, and is compatible with FFPE fine needle aspirates and core needle biopsies.

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Content

  • Simultaneous detection of hundreds of variants across 52 genes relevant to solid tumors
  • Targets relevant hotspots, SNVs, indels, CNVs, and gene fusions from DNA or RNA in a single workflow
  • Includes solid tumor genes targeted by on-market oncology drugs and published evidence
  • Content driven by the Oncomine™ Knowledgebase, which includes content aligned to approved therapies and indications

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Oncomine Focus Assay gene list

ABL1  ERBB2  GNAQ  MYC 
AKT1  ERBB4  HRAS  MYCN 
AKT3  ERBB3  IDH1  NRAS 
ALK  ERG  IDH2  NTRK1 
AR  ESR1  JAK1  NTRK2 
AXL  ETV1  JAK2  NTRK3 
BRAF  ETV4  JAK3  PDGFRA 
CCND1  ETV5  KIT  PIK3CA 
CDK4  FGFR1  KRAS  PPARG 
CDK6  FGFR2  MAP2K1  RAF1 
CTNNB1  FGFR3  MAP2K2  RET 
DDR2  FGFR4  MET  ROS1 
EGFR  GNA11  MTOR  SMO 

Performance

  • Reproducible and sensitive detection of variants across multiple cancer types
  • Compatible with as little as 10 ng sample, including FFPE fine needle biopsies and core needle aspirates
  • Enables results from up to 6 samples per run for DNA and RNA in a single workflow
  • NGS results in days rather than weeks, leveraging Ion Torrent™ sequencing technology and the Ion S5™ System or the Ion PGM™ System
  • Includes Ion Select consumables and reagents manufactured to rigorous standards in our ISO 13485-compliant facility

Analytical performance summary

Across variant types, the Oncomine Focus Assay achieves high sensitivity, specificity, and reproducibility using clinical research samples sequenced on the Ion S5 System.

Variant type Sample Sensitivity PPV (specificity) Two-operator reproducibility
SNV AOHC, QMRC-HD200 99.80% 99% 99%
Indel AOHC 100% 100% 100%
Fusion TriFusion, QMRC-HD784, FFPE tumor samples 97.70% 100% 97.60%
Copy number gain FFPE tumor samples 96.40% [100%] 96.20%

AOHC: Thermo Scientific™ AcroMetrix™ Oncology Hotspot Control (analytical control)
QMRC: Quantitative Multiplex Reference Standard (commercially available cell line mix)
TriFusion: Analytical control (cell line mix)

Reporting

Features enabled with Oncomine informatics:

  • Prioritize relevant variants, reducing calls from hundreds to just a few
  • Identify likely cancer driver variants
  • Quickly create custom, lab-generated reports
  • Driver and prevalence for individual variants
  • Summary files for cancer type
  • Pre-rendered supplementary information tables

Workflow

The Oncomine NGS oncology workflow enables you to go from hundreds of variants down to few relevant cancer drivers, with a report including interpretation of the findings

Oncomine Focus™ Assay Workflow