) announced that it has abided by all the prerequisites of the
IVD Directive and has applied for the CE mark for the extended
use of the MiSeqDx system in clinical laboratories.
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This conformity is a significant turning point for Illumina. It
enables ILMN to acquire the permit to commercialize the new role
of MiSeqDx, enabled by the MiSeqDx Universal Kit, in a number of
European countries. It plans to start shipping the new assay in
Europe, effective Nov 2013.
The MiSeqDx Universal Kit comprises library preparation reagents,
sample index primers, and sequencing consumables. These are
required for laboratories to develop amplicon assays on an in
vitro diagnostic platform.
The MiSeqDx is equipped with Illumina's unique sequencing
technology, which works on synthesis chemistry. This variant of
sequencing technology is widely accepted by genetics researchers
worldwide. The device also enables its users to conduct
diagnostic or research applications on a single and easy-to-use
The latest MiSeqDx Universal Kit is an addition to the existing
MiSeqDx Cystic Fibrosis Carrier Screening Assay and the MiSeqDx
Cystic Fibrosis Diagnostic Assay. With the introduction of the
new MiSeqDx system, clinical laboratories will be able to offer a
wider range of diagnostics tests including critical ones for
cancer, infectious diseases and genetic disorders.
The MiSeqDx system reflects the keen interest of ILMN to expand
its clinical product portfolio through adoption of
next-generation sequencing technologies. With this new offering
the company intends to provide its clinical customers with great
value, coupled with flexibility and reliability.
Currently, ILMN carries a Zacks Rank #3 (Hold).Other medical
stocks that are worth a look include
Titan Pharmaceuticals Inc.
), each carrying a Zacks Rank #1 (Strong Buy).