Comprehensive
Genomic Profiling

Oncomine Comprehensive Assay Plus

Comprehensive
Genomic Profiling

Oncomine Comprehensive Assay Plus

Oncomine Comprehensive Assay Plus

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.

 

 

Comprehensive Genomic Profiling

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On-Demand Webinar Series

Hear from experts using
the Oncomine Comprehensive Assay Plus

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

Dr. Eloisa Jantus Lewintre, PhD
Associate Professor of Cell Biology, Polytechnic University of Valencia, Spain

Multicenter study of the Oncomine Comprehensive Assay Plus using clinical research samples across 5 laboratories showing high sequencing success rates, concordant results, and reproducibility.

 

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

Dr. Nicola Normanno, MD
Scientific Director, IRCCS Istituto Romagnolo per lo Studio dei Tumori, "Dino Amadori", Italy

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.

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Genomic instability metric (GIM) from Oncomine Comprehensive Assay Plus

Dr. Annette Staebler, MD
Head of Gynecological Pathology and Mammary Pathology Division
University Hospital Tuebingen, Germany

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.

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Oncomine Comprehensive Assay Plus
Features and Benefits

 

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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

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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

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Fast

3-day
CGP results

enabled by Ion Torrent technology and easy,
automated
workflows

Timely results are critical for important insights and decisions

icon-robust

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

The all-in-one CGP research test

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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 Prime 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.

 

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FFPE tumor research samples used for the
analytical evaluation

 

The assay demonstrated high analytical performance as part of a sensitive and specific platform for molecular profiling, including detection of complex genomic signatures.2

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.

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Oncomine Comprehensive Assay Plus concordance to orthogonal methods

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Measuring causes and consequences of HRD

HRD testing with Oncomine Comprehensive Assay Plus

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 values 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.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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Concordance of Oncomine Comprehensive Assay Plus HRD status with reference in ovarian cancer research samples

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Is comprehensive genomic profiling (CGP)
the answer to everything ?

No, one size does not fit all. For example, let’s take non-small cell lung cancer (NSCLC) samples. All biomarkers relevant for clinical research can be tested by one, 50 gene targeted panel. It’s cheaper, faster, and it requires less sample input, which is critical in NSCLC, where “tissue is still an issue”. There are four key scenarios in which comprehensive genomic profiling
would be most impactful.

Learn about them in The Pathologist Article “A Comprehensive Answer for Cancer”.

Learn more about the Oncomine Comprehensive Assay Plus

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

 

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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., et al. (2023). Multicentric evaluation of amplicon-based next-generation sequencing solution for local comprehensive molecular tumor profiling. ESMO Poster 219P.
3. Normanno, N. (2023). Future Clinical Perspective of HRD Testing in Ovarian Cancer Samples Using NGS CGP. Genome Web Webinar May 2023.