NEW YORK (GenomeWeb) – Illumina today launched the NextSeq 550Dx, a US Food and Drug Administration-regulated next-generation sequencer, and said that it has expanded the intended use for the existing MiSeq Dx platform to include formalin-fixed paraffin-embedded tissues.
"NGS is beginning to play a significant role in the clinic," said Garret Hampton, Illumina's executive vice president of clinical genomics, in a statement. "Illumina is working to provide clinical solutions that support the diagnosis and management of complex diseases, as well as expanding the [in vitro diagnostic] menu."
"The expansion and launch of these regulated platforms represent regulatory milestones important to the clinical community," said Kathy Davy, vice president of marketing for 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."
The NextSeq 550Dx is the company's second FDA-regulated and CE-IVD marked sequencer, following the MiSeq Dx, which received premarket clearance from the FDA in 2013, the first NGS platform to do so. In 2014, Thermo Fisher Scientific listed its Ion PGM Dx NGS system with the FDA as a Class II medical device.
NextSeq 550Dx has a diagnostic mode and a research mode, enabling its use in clinical research and for developing in vitro diagnostic assays.
Illumina said that the setup of workflows for different applications is "fully integrated" into the instrument's software, and that it "offers fully-integrated onboard analysis software with modular software architecture to support current and future assays."
Under the expanded intended use, the MiSeqDx instrument is now available for use with DNA libraries generated from FFPE tissues. In addition, Illumina now offers the regulated MiSeqDx Reagent Kit v3 as well as the TruSeq Custom Amplicon Kit Dx for library prep for the instrument. These products replace the MiSeqDx Universal Kit 1.0, which was cleared by the FDA in 2013 and enabled clinical labs to analyze DNA from human whole blood.
Illumina said that with its IVD development partners, it is now working on assays for the MiSeqDx that start with FFPE tissues and is developing additional IVD tests.