Comprehensive and simultaneous genomic profiling across 500+ genes, TMB, and MSI from 10ng FFPE sample

Comprehensive genomic profiling without compromises

Comprehensive genomic profiling (CGP) leverages next-generation sequencing (NGS) to simultaneously profile hundreds of genes for key biomarkers associated with research of targeted therapies and immunotherapies, in a single assay. Current on-market research solutions for CGP are limited by high sample input requirements that impede successful testing. Up to 25% of samples fail or are not tested due to insufficient input material, resulting in quantity not sufficient (QNS) readings.

With the Ion Torrent Oncomine Comprehensive Assay Plus, you no longer have to worry about insufficient samples or QNS. Oncomine Comprehensive Assay Plus helps minimize these barriers to testing and enables you to profile over 500 genes to deliver a comprehensive genomic profile from each 20 ng FFPE sample.

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Key highlights of the Oncomine Comprehensive Assay Plus:

  • Profile 500+ unique genes across variant types and key immuno-oncology biomarkers such as TMB and MSI
  • Detect relevant SNVs, indels, CNVs, gene fusions, splice variants, key IO biomarkers and analyze mutational signatures from 20 ng FFPE input
  • Ensure more samples are successfully tested due to low QNS and high sequencing success rates of >95%
  • Streamlined bioinformatics analysis pipeline optimized for Oncomine Comprehensive Assay Plus delivers insights in days

Comprehensive, highly curated gene content

The Oncomine Comprehensive Assay Plus content is composed of key cancer driver genes across all variant classes. These can include mutations in EGFR (L858R, T790M, and Exon 19 deletions), BRAF, KRAS, ERBB2, and MET, fusions involving ALK, ROS1, RET, and NTRK1/2/3, and many other alterations and biomarkers relevant to clinical oncology research.

This assay content is selected based on information in the Oncomine Knowledgebase, one of the world’s largest collections of curated oncology data, and confirmed with industry-leading pharmaceutical partners.

OCA-Plus-Gene-Content


Streamlined in-house NGS workflow

Even with a broad, 500+ gene assay, the Oncomine workflow can take you from 20 ng FFPE sample to variant data in just four days. After sample preparation, up to four samples and one negative control can be multiplexed on the Ion 550 Chip and sequenced on the Ion GeneStudio S5 Plus or Ion GeneStudio S5 Prime systems. Our streamlined Oncomine informatics workflow is an optimized, sample-to-report solution for data analysis that delivers consistent and accurate results. From initial sequence analysis through annotation of relevant biomarkers to creation of a clear and concise report, this complete workflow solution creates efficiencies and enables you to quickly filter to variants of interest and focus on the meaning of your data.


Assay performance

(A) Assay performance on reference controls

Variant type Sensitivity Specificity
SNV 98.9% 99.7%
INDEL 100% 96.6%

(B) Assay performance on CNVs

Variant type Sensitivity Specificity
CNV gain 100% 100%
CNV loss 100% 100%

Figure 1. The performance of the Oncomine Comprehensive Assay Plus verified using (A) commercially available standard material and (B) reference cell lines


Assay performance with FFPE samples

Assay performance was evaluated using real-world commercially sourced FFPE samples against a list of known variants that were confirmed with orthogonal assays.  All alterations were successfully detected with just 20 ng input.


Tumor mutational burden (TMB) assessment

in-silico OCA Plus target regions with whole exome sequencing (WES)

Comparison of OCA Plus with Assay F

TMB harmonization studies

Figure 2. TMB performance of Oncomine Comprehensive Assay Plus. Fig 2A. Whole exome sequencing (WES) has traditionally been the method of choice for TMB quantitation. In-silico analysis against WES was performed to characterize TMB performance of Oncomine Comprehensive Assay Plus. High correlation was demonstrated (Fig. 2A) via scatter plots between the targeted assay (y-axis) and WES (x-axis) mutation counts which was downloaded from TCGA MC33. Fig 2B. Orthogonal TMB vs observed TMB from Oncomine Comprehensive Assay Plus.  A second comparison was conducted using a commercially available with FFPE samples, and demonstrated high correlation in TMB values. And lastly, was independently evaluated against WES and the Oncomine Tumor Mutation Load Assay as part of Friends of Cancer Research’s TMB Harmonization Studies.


Ordering Information

Catalog# Name Size Price (USD)
A46721 Oncomine™ Comprehensive Assay Plus 24 samples 9,528.00