An EU IVDR 2017/746-compliant, scalable whole-genome sequencing solution for clinical diagnostic testing.
The TruSight Whole Genome assay requires installation of the TruSight Whole Genome Analysis Application on your NovaSeq 6000Dx instrument by an Illumina Representative. Contact your Illumina representative to schedule this installation prior to running the assay.
This product is only available in select locations. Please select the location where you would like this product to be shipped to see availability.
The TruSight Whole Genome assay enables clinical laboratories to add WGS to their menu of diagnostic applications and offers:
TruSight Whole Genome offers an EU IVDR–compliant and comprehensive, DNA-to-variant call format (VCF) workflow solution for clinical WGS. This validated solution facilitates adoption of WGS for clinical applications by removing the burdens of developing controls, building bioinformatic pipelines, and performing costly and time-consuming analytical validation studies.
Analytical validation of the TruSight Whole Genome assay was performed in accordance with Clinical and Laboratory Standards Institute (CLSI) guidelines with over 450 clinical samples and over 150 sequencing runs. QC metrics and confidence regions included in the development of the assay identify poor performing samples and filter data. This reduces false-positive and false-negative calls and significantly improves performance.
TruSight Whole Genome is a qualitative in vitro diagnostic device intended for whole-genome sequencing and detection of single nucleotide variants, insertion/deletions, copy number variants, runs of homozygosity, short tandem repeat expansions, and mitochondrial variations in human genomic DNA extracted from blood.
TruSight Whole Genome includes the TruSight Whole Genome Dx Library Prep with UD Indexes and the TruSight Whole Genome Analysis Application Software. The device is intended to be used with compatible downstream germline applications to develop in vitro diagnostic assays, and by qualified laboratory personnel and assay developers.
TruSight Whole Genome is intended to be used on the NovaSeq 6000Dx Instrument.
| Assay time | < 3 days |
|---|---|
| Input quantity | 280ng gDNA |
| Instruments | NovaSeq 6000Dx Instrument |
| Method | Whole-genome sequencing |
| Nucleic acid type | DNA |
| Sample throughput | 6 samples per S2 Dx flow cell and 16 samples per S4 Dx flow cell |
| Species category | Human |
| Technology | Sequencing |
TruSight Whole Genome requires a NovaSeq 6000Dx Reagent Kit and associated buffer cartridge and library tube.
· For a single NovaSeq 6000Dx S2 Reagent Kit v1.5 (300 cycles), 1 NovaSeq 6000Dx S2 Buffer Cartridge and 1 NovaSeq 6000Dx Library Tube is required.
· For a single NovaSeq 6000Dx S4 Reagent Kit v1.5 (300 cycles), 1 NovaSeq 6000Dx S4 Buffer Cartridge and 1 NovaSeq 6000Dx Library Tube is required.
The TruSight Whole Genome Analysis Application must be installed on the NovaSeq 6000Dx instrument in order to run TruSight Whole Genome. This installation must be performed by an Illumina Representative.
TruSight Whole Genome Dx Library Prep
TruSight Whole Genome Analysis Application via DRAGEN server with Illumina Run Manager*
* Must be installed by an Illumina Representative on the NovaSeq 6000Dx instrument
QC based on run and sample performance specifications, metrics, including coverage, uniformity, and base quality, fails poor performing samples to ensure optimal analytical performance without the need for external batch controls.
TruSight™ Whole Genome Dx Library Prep with UD Indexes, 24 sample
20093209
This is an In Vitro Diagnostic (IVD) next generation sequencing library prep that supports the TruSight Whole Genome assay workflow. This kit provides the necessary library prep reagents and indexes to support 24 samples and can only be used with the NovaSeq 6000Dx instrument. The NovaSeq 6000Dx core consumables are not provided in this kit and must be purchased separately. Required software for analysis must be installed by Illumina personnel.
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TruSight Whole Genome Customer Training – Customer Site
20122846
A 1.5-day onsite training for the complete TruSight Whole Genome Dx Library Preparation workflow, with detailed hands-on instruction. Participants will learn all steps of the workflow including sample and library preparation, quality control, best practices, and troubleshooting. Training on Illumina-supported sequencing and data analysis tools specific to the TruSight Whole Genome workflow will be included.
NovaSeq 6000Dx S2 Reagent Kit v1.5 (300 cycles) IVD
20046931
Includes one S2 flow cell (with four lanes), one cluster cartridge, and one sequencing by synthesis (SBS) cartridge to support one 300-cycle run on the NovaSeq 6000Dx. Requires separate purchase of one buffer cartridge and one library tube for each run. All products registered for In Vitro Diagnostic sequencing.
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NovaSeq 6000Dx S2 Buffer Cartridge
20062292
Includes one S2 buffer reagent cartridge to dilute denatured libraries prior to sequencing, required to support each S2 flow cell 300-cycle run.
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NovaSeq 6000Dx S4 Reagent Kit v1.5 (300 cycles) IVD
20046933
Includes one S4 flow cell (with four lanes), one cluster cartridge, and one sequencing by synthesis (SBS) cartridge to support one 300-cycle run on the NovaSeq 6000Dx. Requires separate purchase of one buffer cartridge and one library tube for each run. All products registered for In Vitro Diagnostic sequencing.
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NovaSeq 6000Dx S4 Buffer Cartridge
20062293
Includes one S4 buffer reagent cartridge to dilute denatured libraries prior to sequencing, required to support each S4 flow cell 300-cycle run.
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NovaSeq 6000Dx Library Tube, IVD
20062290
Includes one NovaSeq 6000Dx Library Tube, IVD, required for each S2 or S4 flow cell 300-cycle run.
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NovaSeq 6000Dx Library Tubes Accessory Pack (24 tubes) IVD
20062291
Includes 24 NovaSeq 6000Dx Library Tubes.
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