l******u
发帖数: 936 | 1 http://investor.illumina.com/phoenix.zhtml?c=121127&p=irol-news
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
System
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 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
(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.
About Illumina
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.
Forward-Looking Statements
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.
Illumina, Inc.
Investors:
Rebecca Chambers
858-255-5243
r*******[email protected]
or
Media:
Jennifer Temple
858-882-6822
[email protected] | a********k
发帖数: 2273 | 2 哎，最后也只是approve了一个139的genotyping测试
比传统的multiplex PCR的genotyping贵，慢。保险公司也不多报销一分钱。
and
throughput
FDA
【在 l******u 的大作中提到】
: http://investor.illumina.com/phoenix.zhtml?c=121127&p=irol-news
: 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
: System
: 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,
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