Illumina’s MiSeqDxTM Receives FDA Premarket Clearance with Two Cystic
Fibrosis Assays and Universal Kit for Open Use
Premarket Clearance is an Industry First for a Next-Generation Sequencing
SAN DIEGO -- November 19, 2013
Illumina, Inc. (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.
The MiSeqDx Cystic Fibrosis 139-Variant Assay is designed for simultaneous
detection of 139 clinically relevant disease-causing mutations and variants
within the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
The assay includes all cystic fibrosis-causing variants recommended for
carrier screening purposes by the American College of Medical Genetics and
Genomics (ACMG) and the American College of Obstetricians and Gynecologists
The MiSeqDx Cystic Fibrosis Clinical Sequencing Assay leverages Illumina’s
targeted resequencing chemistry to provide highly accurate sequencing data for
the protein coding regions and intron/exon boundaries of the CFTR gene.
The MiSeqDx Universal Kit enables clinical laboratories to develop their own
diagnostic tests. The kit includes library preparation reagents, sample index
primers, and sequencing consumables needed for laboratories to develop
amplicon assays on the in vitro diagnostic platform.
“Illumina is proud to be the first company to obtain FDA clearance for a
high-throughput DNA sequencing analyzer and next-generation sequencing-based
assays,” said Greg Heath, Senior Vice President and General Manager of
Illumina’s Diagnostics business. “With the FDA clearance of the MiSeqDx,
Illumina is providing clinicians and clinical laboratories with the tools
needed to obtain comprehensive and reliable results from a DNA sequencing
analyzer and enabling them to create and deploy NGS-based molecular diagnostic
tests for cystic fibrosis and a wide-range of other applications.”
The MiSeqDx, MiSeqDx Cystic Fibrosis 139-Variant Assay, MiSeqDx Cystic
Fibrosis Clinical Sequencing Assay, and MiSeqDx Universal Kit are now
available for immediate order with shipment before the end of 2013 in the
United States and Europe. For more information, visit
Illumina (www.illumina.com) is a leading developer, manufacturer, and marketer
of life science tools and integrated systems for the analysis of genetic
variation and function. We provide innovative sequencing and array-based
solutions for genotyping, copy number variation analysis, methylation studies,
gene expression profiling, and low-multiplex analysis of DNA, RNA, and
protein. We also provide tools and services that are fueling advances in
consumer genomics and diagnostics. Our technology and products accelerate
genetic analysis research and its application, paving the way for molecular
medicine and ultimately transforming healthcare.
This release may contain forward looking statements that involve risks and
uncertainties. Important factors that could cause actual results to differ
materially from those in any forward-looking statements are 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 do
not intend to update any forward-looking statements after the date of this
Press spacebar to pause and continue. Press esc to stop.