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The all-in-one CGP research test from one vendor, with results as soon as next-day
The Oncomine Comprehensive Assay Plus, available on the Ion Torrent Genexus System and Ion GeneStudio S5 System, offers a complete, end-to-end comprehensive genomic profiling (CGP) solution. The assay detects a broad range of genomic alterations from 517 genes, including single-nucleotide variants (SNVs), insertions and deletions (indels), copy number variations (CNVs), and fusions.
Additionally, the assay detects genomic signatures such as homologous recombination deficiency (HRD), tumor mutational burden (TMB), and microsatellite instability (MSI). Leveraging proven Ion Torrent technology, the Oncomine Comprehensive Assay Plus delivers a complete, easy, fast, and robust solution to help you meet your laboratory research needs, even at varying levels of next-generation sequencing (NGS) expertise.
Oncomine Comprehensive Assay Plus features and benefits
Complete
1 end-to-end
vendor
for sample-to-report solutions, including instruments, consumables, analysis, and support
Simplifies implementation into your lab, helping to support efficiency
Easy
As little as 20-60 min of hands-on time*
with easy and automated workflows, regardless of experience
Helps reduce handling errors, free up precious time, and helps reduce labor costs
Fast
1-3-day CGP
results*
enabled by Ion Torrent technology for fast turnaround times
Timely results are critical for important insights and decisions
Robust
~94% success
rate1
based on AmpliSeq technology with low sample input requirements
High success rates mean more samples can be tested with informative results
*Timing varies by number of samples, sample type, and instrument used.
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The all-in-one CGP research test
Analytical performance of Oncomine Comprehensive Assay Plus in a multicenter study across tumor types
A multicenter evaluation of the Oncomine Comprehensive Assay Plus run on the Ion GeneStudio S5 systems was performed using a cohort of pan-cancer research samples from more than 13 different tumor types.
The 193 pan-cancer research samples (125 DNA and 68 RNA samples) were analyzed to evaluate concordance of the Oncomine Comprehensive Assay Plus with orthogonal methods (Figure 1). A high overall sequencing success rate of ~94% for DNA and RNA was achieved despite some samples only have 10-20% tumor cell content.1
Figure 1. Distribution of tumor types for the analytical evaluation
of the Oncomine Comprehensive Assay Plus.
The overall concordance between the Oncomine Comprehensive Assay Plus and orthogonal methods was 94.8% for SNVs and indels, 96.5% for CNVs, and 94.2% for fusions. The Oncomine Comprehensive Assay Plus also demonstrated high concordance with orthogonal methods for the detection of HRD, TMB, and MSI genomic signatures.
Based on this study, the Oncomine Comprehensive Assay Plus demonstrated excellent analytical performance as part of a sensitive and specific platform for CGP. Additionally, the Oncomine Comprehensive Assay Plus demonstrated a high level of reproducibility on replicate samples across the laboratories which highlights the potential of the assay to advance research in the field of personalized medicine.
| Genomic alteration or signature | Samples (n) | Concordance (%) |
| SNV/indels | 290 | 94.8 |
| CNVs | 57 | 96.5 |
| Fusions | 52 | 94.2 |
| HRD | 18 | 100 |
| TMB | 32 | 81.3 |
| MSI (pan-cancer/colorectal cancer) | 26/10 | 80.8/100 |
HRD assessment with the Oncomine Comprehensive Assay Plus
The Oncomine Comprehensive Assay Plus detects mutations in 47 genes associated with homologous recombination repair (HRR), including large genomic rearrangements (LGRs) in BRCA1 and BRCA2, which are known causes of HRD. In addition, the consequences of HRD are measured using a genomic instability metric (GIM).
The GIM is a numeric value between 0 and 100 that summarizes the unbalanced copy number changes across the autosomes resulting from HRD. Higher GIM values correlate with more genomic instability.
Oncomine Comprehensive Assay Plus HRD performance in ovarian cancer research samples
In a retrospective multicenter study of n=100 stage III–IV ovarian cancer research samples from the MITO16/MaNGO-OV2 clinical study, HRD status was determined based on the presence of pathogenic mutations in BRCA1 and BRCA2 in combination with GIM using a predefined threshold of ≥16 to define a high GIM.2
Oncomine Comprehensive Assay Plus run on the Ion GeneStudio S5 Systems had good overall concordance with various orthogonal methods for HRD assessment in ovarian cancer research samples.
| Reference Method | ||||
| Positive | Negative | Total | ||
| Oncomine Comprehensive Assay Plus | Positive | 51 | 7 | 58 |
| Negative | 1 | 27 | 28 | |
| Total | 52 | 34 | 86 | |
| HRD status (combined): | |
| Oncomine Comprehensive Assay Plus vs. reference method | |
| Sensitivity | 98.1% |
| Specificity | 79.4% |
| Overall concordance | 90.7% |
NGS systems for the Oncomine Comprehensive Assay Plus
The Oncomine Comprehensive Assay Plus is available on the Genexus System and additionally available for use on the Ion GeneStudio S5 systems with manual or automated library preparations.
Ordering information
For Ion GeneStudio S5 systems
For the Genexus System
Featured resources
References
1. Jantus-Lewintre E, Rappa A, Ruano D et al. (2025) Multicenter in-house evaluation of an amplicon-based next-generation sequencing panel for comprehensive molecular profiling. Mol Diagn Ther 29(2):249–261.
2. Normanno N. (2023) Future clinical perspective of HRD testing in ovarian cancer samples using NGS CGP. Genome Web Webinar; 2023 May.
CN: 57701
For Research Use Only. Not for use in diagnostic procedures.