Illumina Applies CE Mark to Expanded MiSeqDx™ System

  Illumina Applies CE Mark to Expanded MiSeqDx™ System

         New Application Facilitates Development of Diagnostic Tests

Business Wire

SAN DIEGO -- September 25, 2013

Illumina, Inc. (NASDAQ:ILMN) today announced that it declared conformity with
the requirements of the IVD Directive and has applied the CE mark to expand
the use of the MiSeqDx system in clinical laboratories. These laboratories are
now able to develop diagnostic tests using Illumina’s new MiSeqDx Universal
Kit on the MiSeqDx. The MiSeqDx Universal Kit joins the MiSeqDx Cystic
Fibrosis Carrier Screening Assay and the MiSeqDx Cystic Fibrosis Diagnostic
Assay in Illumina’s expanding line of clinical products available for the
MiSeqDx.

The MiSeqDx uses Illumina’s industry-leading sequencing by synthesis
chemistry, the sequencing technology most widely adopted by genetics
researchers worldwide. The instrument offers users the ability to run
diagnostic or research applications on a single, easy-to-use system. The
MiSeqDx Universal Kit includes the library preparation reagents, sample index
primers, and sequencing consumables needed for laboratories to develop
amplicon assays on an in vitro diagnostic platform.

“The MiSeqDx demonstrates Illumina’s continuing commitment to the clinical
adoption of next-generation sequencing technologies. The company’s validated
products provide reliability and flexibility to our clinical customers,” said
Greg Heath, Senior Vice President and General Manager of Illumina’s
Diagnostics business. “The MiSeqDx greatly expands the opportunity for
clinical laboratories to offer diagnostic tests for wide-ranging applications
including genetic and infectious diseases and cancer.”

The new functionality for the MiSeqDx, enabled by the MiSeqDx Universal Kit,
will be commercialized in a number of European countries that require the CE
mark, and will begin shipping in Europe beginning in November 2013. For more
information, visit www.illumina.com/MiSeqDxPlatform.

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 contains forward-looking statements that involve risks and
uncertainties. Examples of forward-looking statements include, but are not
limited to, statements we make regarding the expected order availability date.
Important factors that could cause actual results to differ materially from
those in any forward-looking statements include challenges inherent in
developing and launching new products and services and the other factors that
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.

Contact:

Illumina, Inc.
Investors:
Rebecca Chambers, 858-255-5243
rchambers@illumina.com
or
Media:
Jennifer Temple, 858-882-6822
pr@illumina.com
 
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