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

Truly comprehensive genomic profiling without compromises

Comprehensive genomic profiling (CGP) is advancing precision oncology research through the analysis of multiple relevant biomarkers in a single next-generation sequencing (NGS) test. Current CGP solutions are hindered by technology limitations such as large sample input volumes, high quantity not sufficient (QNS) rates, and complex workflows with bioinformatics challenges. Oncomine Comprehensive Assay Plus provides CGP without the sacrifices.

Key highlights of the Oncomine Comprehensive Assay Plus:

  • Profile 500+ unique genes for single gene and multiple gene biomarker insights
  • Detect single gene biomarkers from all variant types including SNVs, indels, CNVs, gene fusions, and splice variants
  • Analyze complex multi-gene biomarkers for mutational signatures, including tumor mutational burden (TMB) and microsatellite instability (MSI) for immunotherapy research
  • Ensure more samples are successfully tested due to low "quantity not sufficient" (QNS) readings and high sequencing success rates of >95%
  • Streamlined bioinformatics analysis pipeline optimized for Oncomine Comprehensive Assay Plus delivers insights in days

Analyze multiple biomarkers simultaneously

Detect and analyze all single and multiple gene biomarkers simultaneously from just 20 ng FFPE sample with the Oncomine Comprehensive Assay Plus. 


Single gene biomarkers

Detect all types of single-gene variants for targeted-therapy research, such as single-nucleotide variants (SNVs), indels, fusions, splice variants, and copy number variants (CNVs), including both CNV gain and CNV loss


Multiple gene biomarkers

Study potential response to immunotherapies with TMB assessment, study predisposition to genetic hypermutability by comparing MSI regions, and analyze mutational signatures for insights into etiological factors in tumorigenesis

Every gene is relevant

The Oncomine Comprehensive Assay Plus covers over 500 unique genes, including key cancer driver genes such as EGFR, BRAF, KRAS, ERBB2, and MET, fusions involving ALK, ROS1, RET, and NTRK1/2/3, and more.  Each and every gene is carefully 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. 

There is no CGP without CNV

Copy number variation (CNV) is a structural variant detected in oncogenes and tumor suppressor genes that results in duplication, deletion, or inversion of genetic sequences.  Currently, 116 unique CNV genes are studied in over 1,000 active clinical trials. These variants are critical to understanding of tumorigenesis and this importance is underscored with this statistic.  The exclusion of CNVs in genomic profiling means you are missing valuable insights and does not translate into truly comprehensive genomic profiling.

From FFPE sample to biomarker insights

Even with a broad, 500+ gene assay, the Oncomine workflow takes you from 20 ng FFPE sample to biomarker insights in just four days. After sample preparation, four samples and one negative control can be multiplexed on the Ion 550 Chip and sequenced on the Ion GeneStudio S5 systems. The raw sequencing data is then analyzed with Oncomine informatics, a streamlined bioinformatics solution that turns sequencing data into annotated biomarker insights.  This analysis solution will help you:

  • Prioritize and call variants
  • Identify and annotate cancer drivers for further investigation
  • Quickly create custom, lab-generated reports
  • Help guide decisions for your research

Assay performance

Performance of the Oncomine Comprehensive Assay Plus was evaluated with commercially sourced reference controls and FFPE samples.  Highly accurate and sensitive detection for all gene variants are shown, with CNV gain and CNV loss demonstrating exceptional 100% specificity.

Variant type Sensitivity Specificity
SNVs 98.9% 99.7%
Indels 100% 96.6%
CNV gain 100% 100%
CNV loss 93% 100%
Fusions 95.4% 95.4%

Figure 1. The performance of the Oncomine Comprehensive Assay Plus verified using both commercially sourced reference controls and FFPE samples.

Exceptional sensitivity in variant detection with FFPE samples

Assay performance was evaluated for variant detection across different mutational types using a pool of commercially sourced, orthogonally validated FFPE samples. Variant types were detected with 100% sensitivity in all samples. All alterations were successfully detected with just 20 ng input.

 Click image to enlargeFigure 2.

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 3. TMB performance of Oncomine Comprehensive Assay Plus. Fig 3A. 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. 3A) via scatter plots between the targeted assay (y-axis) and WES (x-axis) mutation counts which was downloaded from TCGA MC33. Fig 3B. 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.

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Ordering information

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