Illumina Receives FDA Premarket Clearance for MiSeqDx System

Illumina

today announced that it received premarket clearance from the U.S. Food and Drug Administration (FDA) for the MiSeqDx system, the first high-throughput DNA sequencing analyzer to receive FDA clearance. Illumina also received FDA premarket clearance for the MiSeqDx Cystic Fibrosis 139-Variant Assay, MiSeqDx Cystic Fibrosis Clinical Sequencing Assay, and MiSeqDx Universal Kit. The MiSeqDx benchtop sequencer offers users the ability to run diagnostic or research applications on a single, easy-to-use system. Designed and validated for the clinical market, the MiSeqDx with the portfolio of FDA-cleared in vitro diagnostic kits and assays leverage Illumina's sequencing by synthesis (SBS) chemistry for high confidence in results.