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.
On-Demand Webinar Series
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.
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.
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.
of sample-to-report solutions, including instruments, consumables, analysis, and support
Simplifies implementation into your lab, helping to support efficiency
compared to hybrid capture-based NGS assays, which require
labor-intensive steps
Helps reduce handling errors, free up precious time, and reduce labor costs
enabled by Ion Torrent technology and easy,
automated
workflows
Timely results are critical for important insights and decisions
with sample input requirements of only
20 ng
DNA/RNA
High success rates mean more samples can be tested with informative results
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.
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.
Oncomine Comprehensive Assay Plus concordance to orthogonal methods
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.
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.
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”.
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.
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