Illumina has announced the introduction of its NextSeq 550Dx instrument, the company's second FDA-regulated and CE-IVD marked next-generation sequencing (NGS) system.

The company also announced that the intended use for the MiSeqDx instrument has been updated to include the use of DNA libraries generated from formalin-fixed paraffin embedded (FFPE) tissues, paving the way for clinical labs to use FFPE samples when developing clinical tests for new applications. With the NextSeq 550Dx and the MiSeqDx, Illumina now has a highly robust diagnostic NGS product portfolio capable of covering a broad range of clinical applications to serve almost any clinical lab need for NGS-based in vitro diagnostic (IVD) products.

Illumina introduces the NextSeq 550Dx instrument, which is the second FDA regulated CE-IVD market platform to deliver the power of high-throughput NGS to the clinical laboratory. With dual boot functionality, the NextSeq 550Dx platform includes a diagnostic mode (Dx mode) and a research mode, which provides the flexibility to perform both clinical research and develop a range of IVD assays on a single instrument. For large clinical laboratories, the NextSeq 550Dx instrument offers a validated high-throughput platform and will soon provide access to an expanding pipeline of clinical applications in oncology and reproductive health.

Assays that are run on the NextSeq 550Dx instrument follow a simple process including sequencing and data analysis. The setup of workflows for different applications are fully integrated in NextSeq 550Dx software. The instrument also offers fully-integrated onboard analysis software with modular software architecture to support current and future assays.

"NGS is beginning to play a significant role in the clinic," said Garret Hampton, executive vice president of Clinical Genomics at Illumina. "Illumina is working to provide clinical solutions that support the diagnosis and management of complex diseases, as well as expanding the IVD menu."