Both FDA-regulated and CE-in vitro diagnostic (IVD) marked, the NextSeq 550Dx instrument enables clinical laboratories to develop and perform a wide range of applications, from NGS IVD assays using targeted panels, to clinical research applications that include methods from targeted panels to whole genomes.

Image Credit: Illumina, Inc

Flexibility of dual operating modes

Work within a regulated sequencing workflow for developing diagnostic tests and leveraging future NGS IVD tests in the pipeline while retaining the flexibility to work in a research environment and use the full range of Illumina sequencing methods for a wide range of applications.

NextSeq™ 550Dx sequencer

Image Credit: Illumina, Inc

Consistency of a clinical instrument

The instrument and sequencing reagents are CE-marked and regulated by the FDA, developed under design control principles, manufactured under Current Good Manufacturing Practices (cGMPs), and verified for consistent assay performance.

For In Vitro Diagnostic Use. Not available in all regions and countries.