The all-in-one CGP research test from one vendor, with results in as little as three days

The Ion Torrent Oncomine Comprehensive Assay Plus, available on the Ion GeneStudio S5 System, offers a complete, end-to-end comprehensive genomic profiling (CGP) solution. The assay detects a broad range of genomic alterations, including single-nucleotide variants (SNVs), insertions and deletions (indels), copy number variations (CNVs), and fusions from 517 genes.

 

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

of sample-to-report solutions, including instruments, consumables, analysis, and support

 

Simplifies implementation into your lab, helping to support efficiency

 

Easy

90% less hands-on time1

compared to hybrid capture-based NGS assays, which require
labor-intensive steps

 

Helps reduce handling errors, free up precious time, and reduce labor costs

 

Fast

3-day CGP
results

enabled by Ion Torrent technology and easy, automated workflows

 

Timely results are critical for important insights and decisions

 

Robust

~94% success
rate2

with sample input requirements of only
20 ng DNA/RNA

 

High success rates mean more samples can be tested with informative results

Multicenter study of the Oncomine Comprehensive Assay Plus for local comprehensive genomic profiling

Multicenter study of the Oncomine Comprehensive Assay Plus using clinical research samples across five laboratories showing high sequencing success rates, concordant results, and reproducibility.

Dr. Eloisa Jantus Lewintre, PhD

Associate Professor of Cell Biology

Polytechnic University of Valencia

Spain

Dr. Eloisa Jantus Lewintre

Future clinical perspective of HRD testing in ovarian cancer samples using NGS CGP

Retrospective multicenter study evaluating the Oncomine Comprehensive Assay Plus on a cohort of ovarian cancer research samples supporting good overall concordance with the reference for BRCA1/2, genomic instability, and HRD.

Dr. Nicola Normanno, MD

Scientific Director

IRCCS Istituto Romagnolo per lo Studio dei Tumori, "Dino Amadori"

Italy

Dr. Nicola Normanno, MD

Genomic instability metric (GIM) from Oncomine Comprehensive Assay Plus

Analytical validation of GIM in ovarian cancer research samples at Tuebingen University with known reference standards and how to assess borderline cases when evaluating continuous variables.

Dr. Annette Staebler, MD

Head of Gynecological Pathology and Mammary Pathology Division

University Hospital Tuebingen

Germany

Annette Staebler

The all-in-one CGP research test

Analytical performance of Oncomine Comprehensive Assay Plus in a multicenter study across tumor types

In a multicenter study across five different countries in Europe using the Oncomine Comprehensive Assay Plus and the Ion GeneStudio S5 System, 193 precharacterized clinical research FFPE samples from >13 different tumor types were analyzed. A high overall sequencing success rate of ~94% for DNA and RNA was achieved despite some samples only have 10-20% tumor cell content.2

 

Concordance was calculated relative to orthogonal methods which included NGS, WGS, fragment analysis, FISH, RT-PCR, and MLPA.

oncomine assay plus analytical performance

The assay demonstrated high analytical performance as part of a sensitive and specific platform for molecular profiling, including detection of complex genomic signatures.The overall performance of the Oncomine Comprehensive Assay Plus in detecting genomic alterations from over 400 variants was >95% concordance.

 

Additionally, concordance for genomic signatures, HRD, TMB, and MSI was high compared to orthogonal methods which highlights the potential of the assay to advance research in the field of personalized medicine.

Alteration/signature Samples (n) Concordance (%)
SNVs 258 95.3
Indels 32 90.6
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 testing with 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 or genomic scarring are measured using a genomic instability metric (GIM).

 

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.

 

hrd testing

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.3

Oncomine Comprehensive Assay Plus had good overall concordance with various orthogonal methods for HRD assessment in ovarian cancer research samples. 


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If you are interested in learning more about Oncomine CGP solutions for solid tumors and see a demo, please request contact from a local representative.

 

For Research Use Only. Not for use in diagnostic procedures.

References

1. One hr hands-on time for the Oncomine Comprehensive Assay Plus for library prep and sequencing compared to competitor literature stating 10.5 hr needed for manual workflow—current as of August 2024.

2. Jantus-Lewintre, E., Rappa, A., Ruano, D., van Egmond, D., Gallach, S., Gozuyasli, D., Durães, C., Costa, J. L., Camps, C., Lacroix, L., Kashofer, K., van Wezel, T., & Barberis, M. (2025). Multicenter In-House Evaluation of an Amplicon-Based Next-Generation Sequencing Panel for Comprehensive Molecular Profiling. Molecular diagnosis & therapy, 29(2), 249–261. https://doi.org/10.1007/s40291-024-00766-2

3. Normanno, N. (2023). Future Clinical Perspective of HRD Testing in Ovarian Cancer Samples Using NGS CGP. Genome Web Webinar May 2023.

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