SAN DIEGO–(BUSINESS WIRE)–Illumina, Inc. (NASDAQ: ILMN) announced today 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 MiSeq™Dx 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.”
For additional information on the NextSeq 550Dx, please visit www.illumina.com/nextseq550dx.
The expanded intended use of the MiSeqDx instrument, which was the first FDA regulated NGS sequencer, enables the development of additional advanced diagnostic products and services at clinical labs by giving clinicians access to information generated on Illumina’s NGS technology. In addition to the updated intended use for the MiSeqDx system, Illumina also offers the regulated MiSeqDx Reagent Kit v3, the latest version of Illumina sequencing chemistry available to MiSeqDx customers, and the TruSeq™ Custom Amplicon Kit Dx for library preparation. These new products replace the MiSeqDx Universal Kit 1.0, which was regulated by the FDA in 2013 and allowed clinical labs to conduct DNA analysis using DNA obtained from human whole blood.
“The expansion and launch of these regulated platforms represent regulatory milestones important to the clinical community,” said Kathy Davy, Vice President of Marketing, Clinical Genomics at Illumina. “The most relevant genetic information that can help cancer patients is often contained in FFPE tissues removed during surgery. Information gleaned from these samples can inform clinicians about tumor biology and help guide therapeutic selection.”
Illumina has updated the existing intended use for the MiSeqDx system to include the use of FFPE sample inputs for assays performed on the instrument. This update will support the launch of the following new reagent kits:
- TruSeq Custom Amplicon Kit Dx
- TruSeq Custom Amplicon Dx – FFPE QC Kit
- MiSeqDx Reagent Kit v3 (2×300)
The MiSeqDx now has the following IVD menu:
- Cystic Fibrosis 139-Variant Assay
- Cystic Fibrosis Sequencing Assay
- Extended RAS Panel
- Germline Variant Module
- Somatic Variant Module
Illumina and its IVD development partners are now developing assays that use FFPE as a starting point on the MiSeqDx instrument and are working to bring additional IVD tests to the MiSeqDx. For more information on the expanded use of the MiSeqDx system, visit http://www.illumina.com/miseqdx.
Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as the global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical, and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture, and other emerging segments. To learn more, visit www.illumina.com and follow @illumina.
Use of forward-looking statements
This release contains forward-looking statements that involve risks and uncertainties. These forward-looking statements are based on our expectations as of the date of this release and may differ materially from actual future events or results. Among the important factors that could cause actual results to differ materially from those in any forward-looking statements are (i) our ability to further develop and commercialize our instruments and consumables, and to deploy new products such as the NextSeq 550Dx instrument, services and applications, and expand the markets for our technology platforms; (ii) our ability to manufacture robust instrumentation and consumables; (iii) our ability to successfully identify and integrate acquired technologies, products or businesses; (iv) the future conduct and growth of the business and the markets in which we operate; and (v) challenges inherent in developing, manufacturing, and launching new products and services, together with other factors detailed in our filings with the Securities and Exchange Commission, including our most recent filings on Forms 10-K and 10-Q, or in information disclosed in public conference calls, the date and time of which are released beforehand. We undertake no obligation, and do not intend, to update these forward-looking statements, to review or confirm analysts’ expectations, or to provide interim reports or updates on the progress of the current quarter.