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Illumina Receives FDA Premarket Clearance for MiSeqDx System

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Illumina (NASDAQ: ILMN) 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.

See full press release

Posted-In: News Guidance Contracts FDA Management Global

 

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