Premarket Clearance is an Industry First for a Next-Generation
SAN DIEGO--(BUSINESS WIRE)--Nov. 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
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 (ACOG).
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 www.illumina.com/FirstNGSIVD.
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 release.
Source: Illumina, Inc.