TruSight Oncology Comprehensive IVD Solutions

Maximize actionable biomarker content

Bring precision medicine to your lab with an IVD kitted CGP solution

Two diverse female healthcare providers standing in an office hallway, one holding a tablet, having a discussion.

One test.
One report.
One goal.

TruSight Oncology Comprehensive products are IVD test kits for comprehensive genomic profiling (CGP) based on DNA and RNA, consolidating multiple iterative tests into one. Using a single test for hundreds of current and emerging biomarkers, including a pan-cancer companion diagnostic, qualified healthcare professionals can access a clinically relevant report with actionable results to help redefine the journey for patients with cancer.

Learn how this IVD test can help guide personalized care decisions by maximizing actionable biomarker content in a single test to help drive better outcomes through precision medicine.

TruSight Oncology Comprehensive products

TruSight Oncology Comprehensive (EU)

CE-marked IVD kitted solution for comprehensive genomic profiling for multiple solid tumor types.

TruSight Oncology Comprehensive (US)

FDA-approved IVD kitted solution for comprehensive genomic profiling for multiple solid tumor types.

Key features and benefits

Generate genomic profiles

Get mutational information on more than 500 genes to match patients with optimal therapeutic options. Detect DNA and RNA variants plus genomic signatures across multiple solid tumor types.

Help inform critical decisions

Test results help inform therapy decisions according to clinical guidelines. Content includes key biomarkers associated with drug labels, major clinical guideline recommendations, and clinical trials.

Offer in-house testing

Keep data in-house and avoid losing samples to send-out services. A streamlined four- to five-day sample-to-answer workflow helps serve more patients locally.

Conserve biopsy samples

Minimize risk of quantity not sufficient (QNS) issues by maximizing the genetic insights from each sample with comprehensive genomic coverage from a single test.

Consolidate multiple tests

Get comprehensive results in a single easy-to-interpret report, without waiting weeks for sequential results from separate tests. Leverage NGS to interrogate potential variants across different classes in a single test.

Maximize actionability

Obtain coverage of multiple variant classes in coding regions of cancer-related genes and genomic signatures. Stay ahead of expanding guidelines and new scientific literature with a comprehensive assay.

Key genes

Selection of key genes detected by TruSight Oncology Comprehensive^a products:

Pan-cancer genes: BRAF NTRK1 NTRK2 NTRK3 RET

Genes with biomarkers of significance
Breast	AKT1	BRCA1	BRCA2	ESR1	PALB2	PIK3CA	PTEN
Colorectal	KRAS	NRAS	POLD1	POLE
Bone	ERG	ETV1	ETV4	EWSR1	FEV	FLI1	FUS	HEY1
Bone	IDH1	NCOA2	PATZ1
Lung	ALK^b	EGFR	KRAS	MET^b	MTOR	ROS1^b
Melanoma	KIT	NRAS	ROS1^b
Ovarian	BRCA1	BRCA2
CNS	APC	ATRX	CDKN2A	CDKN2B	CTNNB1	EGFR	H3F3A	HIST1H3B
	HIST1H3C	IDH1	IDH2	MYCN	NF1	PTCH1	TERT	TP53
	SMO
Prostate	ATM	ATR	BARD1	BRCA1	BRCA2	BRIP1	CDK12	CHEK1
	CHEK2	FANCA	FANCL	FGFR3	MLH1	MRE11	NBN	PALB2
	PTEN	RAD51B	RAD51C	RAD51D	RAD54L	TACC3
Thyroid	TERT
Uterine and cervical	BCOR	BRCA2	ESR1	FOXO1	GREB1	NCOA1	NCOA2	NCOA3
	NUTM2A	NUTM2B	PAX3	PAX7	POLE	SMARCA4	TP53	YWHAE
	ZC3H7B

TruSight Oncology Comprehensive products also contain many genes with biomarkers of potential clinical significance based on scientific literature evidence, presence in clinical trials, or linked to labels or guidelines in other histologies (content analysis provided by Velsera Knowledgebase v8.20, September 2024). These genes are in addition to the genes with biomarkers of clinical significance linked to current drug labels or guidelines.
Small DNA variants only in the US version of TSO Comprehensive.

From sample to report in just 4–5 days

Implement a streamlined, IVD sample-to-answer solution, empowering you to generate accurate test results locally and improve the chances patients will be matched to targeted therapies or clinical trials.

Step 1: Sample specimen

TruSight Oncology Comprehensive products provide more information from less sample, in less total time compared to current iterative testing methods.

Step 2: DNA and RNA extraction

TruSight Oncology Comprehensive products can use DNA and RNA extracted simultaneously from the same sample as input material. (Extraction kits must be purchased separately).

Step 3: Library preparation

Library preparation is based on proven hybrid–capture chemistry using biotinylated probes and streptavidin- coated magnetic beads to purify selected targets from DNA- and RNA-based libraries.

Step 4: Sequencing to clinical report

Test results, supported by an expertly curated Knowledgebase, are presented in a single, streamlined results report.

Fully automated workflow on-instrument

Sequencing
Base calling and QC
Variant calling
Interpretation and final report: Get a clear, easy-to-read, clinically relevant final report that accurately identifies actionable mutations and can help inform therapy decisions.

View sample TSO Comprehensive report

Pipeline of companion diagnostic indications under development

TruSight Oncology Comprehensive products are indicated as companion diagnostic tests. See the product’s package insert for information on approved indications. Illumina has partnered with pharma companies to develop a growing pipeline of additional companion diagnostic indications.

The power of in-house CGP

Offer a turnaround time of 4-5 days versus multiple weeks for sendout testing
Automatically generate an intuitive report by leveraging integrated, on-board design
Streamline implementation efforts with validated IVD reagents
Maintain control of the original samples and data; reanalyze data when a new guideline, drug, or clinical trial becomes available
Improve access by offering tests at locations closer to the patient

Resources

Precision medicine unlocked for all

In this video, healthcare experts discuss how CGP testing maximizes the information available in each tissue sample and helps support precision medicine as the new standard of care.

Bring cancer into focus with CGP

Learn more about CGP and its benefits in identifying potentially clinically relevant genomic alterations across a variety of tumor types.

CGP empowers broader access to precision oncology

Download this infographic and see how CGP can improve detection of actionable genomic alterations in just one test.

Speak to a specialist

Contact an Illumina representative to learn more about the TruSight Oncology product line and find the right solutions for your needs.

Reference

Content analysis provided by Pierian Knowledgebase v8.5, February 2023.

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MiSeq i100 Series

MiSeq i100 Series

MiSeq i100 Series

MiSeq i100 Series

MiSeq i100 Series

MiSeq i100 Series

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For every lab, everywhere

For every lab, everywhere

TruSight Oncology Comprehensive IVD Solutions

One test.One report.One goal.

TruSight Oncology Comprehensive products

Key features and benefits

Generate genomic profiles

Help inform critical decisions

Offer in-house testing

Conserve biopsy samples

Consolidate multiple tests

Maximize actionability

Key genes

From sample to report in just 4–5 days

Step 1: Sample specimen

Step 2: DNA and RNA extraction

Step 3: Library preparation

Step 4: Sequencing to clinical report

One test.
One report.
One goal.