NextSeq 550Dx Instrument applications and methods

Supporting IVD testing and clinical research

Perform and develop diagnostic assays and fuel clinical research applications with sequencing and array scanning on one instrument

NovaSeq 550Dx flow cell

Key diagnostic applications

When used in diagnostic mode on the NextSeq 550Dx, Illumina DNA Prep with Enrichment Dx supports user-supplied probe panels that meet the required specifications, including fixed and custom panels of varying sizes.

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Library prep
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Sequence
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Analyze

VeriSeq NIPT Solution v2 detects aneuploidies 21, 18, and 13, rare autosomal aneuploidies, sex chromosome aneuploidies, and partial duplications and deletions ≥7 Mb for all autosomes as part of a clinical prenatal screening solution run on the NextSeq 550Dx Instrument.

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Library prep
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Sequence
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Analyze

Integrated on-instrument data analysis solution available preinstalled on the VeriSeq Onsite Server v2.

TruSight Oncology Comprehensive (EU) is a CE-marked IVD comprehensive genomic profiling (CGP) test for analyzing multiple DNA and RNA variants plus biomarker signatures such as TMB and MSI across multiple cancer types. Indicated for use on the NextSeq 550Dx Instrument, TruSight Oncology Comprehensive (EU) consolidates multiple biomarkers into a single test and enables targeted therapies and clinical trials with actionable, easy-to-interpret results.

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Library prep
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Sequence
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Analyze

Local Run Manager TruSight Oncology Comprehensive (EU) Analysis Module (on-instrument software)

Key clinical research applications (in Research Mode)

The TruSight Tumor 170 workflow covers 170 genes associated with common solid tumors. It simultaneously analyzes DNA and RNA, covering a wide range of genes and variant types.

Read interview

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Prep
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Sequence
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Analyze

Investigate the protein-coding regions of the genome to uncover genetic influences on disease and population health.

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Prep
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Sequence
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Analyze

Comprehensively target disease-associated regions of the exome with high analytical sensitivity and specificity.

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Prep
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Sequence
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Analyze

Intended Use for the NextSeq 550Dx Instrument

United States:

The NextSeq 550Dx Instrument is intended for targeted sequencing of DNA libraries from human genomic DNA extracted from peripheral whole blood or formalin-fixed, paraffin-embedded (FFPE) tissue when used with in vitro (IVD) diagnostic assays. The NextSeq 550Dx Instrument is not intended for whole genome or de novo sequencing. The NextSeq 550Dx Instrument is to be used with specific registered, certified, or approved in vitro diagnostic reagents and analytical software.

European Union:

The NextSeq 550Dx instrument is intended for sequencing of DNA libraries when used with in vitro diagnostic assays. The NextSeq 550Dx instrument is to be used with specific registered, certified, or approved in vitro diagnostic reagents and analytical software.