Oncomine Precision Assay | Thermo Fisher Scientific

Next-generation oncology solution

The Oncomine Precision Assay on the Ion Torrent Genexus System is a next-generation genomic profiling solution that can allow every laboratory to deliver a genomic profile with a one-day, hands-free workflow.^†

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The Oncomine Precision Assay on the Ion Torrent Genexus System is a next-generation solution for genomic profiling that’s accessible for laboratories of all sizes. Now labs can employ a hands-off workflow to detect key biomarkers such as EGFR, ALK, BRAF, ROS1, NTRK, RET, or ERBB2 from formalin-fixed paraffin-embedded (FFPE) tissue or liquid biopsy specimens in one day.

Mutation, CNV, and fusion variant types across 50 key genes such as EGFR, ALK, BRAF, ROS1, RET, KRAS, PIK3CA, and ERBB2, among others
One-day, hands-free workflow with only two touch points and 10 minutes of hands-on time
Only 10 ng of DNA/RNA required, allowing for more samples to be tested
Compatible with FFPE tissue as well as liquid biopsy samples

Oncomine Precision Assay content

Featuring the most prevalent and potentially relevant cancer driver variants across 50 genes, including potentially important resistance driving variants, this assay is ideal for fast genomic profiling in clinical cancer research.

Key Cancer Driver Genes and Variants for Clinical Research

Low input, high success rate

Some NGS send-out labs have test failure rates of 20% due to their high input requirement. At that rate, one out of every five samples submitted will not pass due to lack of tissue, and many more are never submitted for testing at all.

Not with Oncomine Solutions.

You can experience a sequencing success rate of over 95% with Oncomine assays, because we only require 10 ng of nucleic acid input. That means you can get an NGS result for most of the precious samples you have.

FFPE tissue and liquid biopsy compatible

In the drive to profile every important cancer sample, the tissue is still an issue, especially in some types of cancer such as non-small cell lung cancer (NSCLC). The Oncomine Precision Assay can deliver results from FFPE tissue as well as liquid biopsy if tissue is not available and can also be used for follow up to monitor the cancer profile development

FusionSync detection technology

There are a number of known and recurrent fusion isoforms that constitute a majority of the fusions detected. Having specific designs for these isoforms is important to maximize detection, even in challenging situations when sample input or transcript levels are low.

The optimized, synced design of the Oncomine Precision Assay enables comprehensive, sensitive fusion detection (including novel fusions in select driver genes) at low transcript or input levels.

Targeted known-fusion detectionfor the most common and prevalent fusion isoforms (e.g., EML4 -ALK, ETV6-NTRK3, KIF5B-RET, etc.)
Non-targeted detection of novel fusion combinations of targeted driver and partner genes
Novel fusionsdetection by proprietary exon tiling imbalance method

Oncomine Precision Assay performance

Performance of Oncomine Precision Assay on FFPE controls

Sample	Range	Variant type	# of variants per sample	# of sample replicates	Sensitivity	PPV
Internal FFPE Control	4.8% + 2.3% SD AF*	SNV	67	32	99.6%	99.6%
Internal FFPE Control	4.8% + 2.3% SD AF*	INDEL	4	32	100%	100%
Horizon Structural Multiplex FFPE Reference Standard	3.5% to 17% AF*	SNV/INDEL	15	32	100%	100%
Horizon Structural Multiplex FFPE Reference Standard	4.5 copies	CNV	1	32	93.8%	100%
SeraSeq FFPE Tumor Fusion RNA Reference Material	10–258 copies	FUSION	13	32	98.6%	99.3%
SeraSeq FFPE NTRK Fusion RNA Reference Material	94–377 copies	FUSION	15	32	99.2%	99.2%
SeraSeq® Lung & Brain CNV Mix	+ 3 copies (5 copies)	CNV	2	32	100%	100%
SeraSeq® Breast CNV Mix	+ 3 copies (5 copies)	CNV	2	32	100%	100%

Note: Testing was performed at multiple internal R&D laboratories as part of product verification testing. Samples were run at different plexy levels. Additional verification and validation testing will be performed using the Oncomine Precision Assay and FFPE controls; therefore final performance values can change.
* Indicates observed allele frequency using Oncomine Precision Assay on Genexus System.

Performance of Oncomine Precision Assay on liquid biopsy controls

Range	Variant type	# of variants per sample	# of sample replicates	Sensitivity	PPV
0.33% + 0.17% SD AF*	SNV	67	32	89.2%	100%
0.33% + 0.17% SD AF*	INDEL	4	32	100%	100%
1.16X fold change	CNV	1	32	100%	100%
1% Tri-Fusion and MET Exon 14 Skip in Total RNA	FUSION	1	32	97.7%	96.4%

NOTE: Testing was performed at multiple internal R&D laboratories as part of product verification testing. Samples were run at different plexy levels. Additional verification andvalidation testing will be performed using the Oncomine Precision Assay and FFPE controls; therefore final performance values can change.
* Indicates observed allele frequency using Oncomine Precision Assay on Genexus System.

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