Illumina Applies CE Mark to MiSeqDx™ Cystic Fibrosis System

  Illumina Applies CE Mark to MiSeqDx™ Cystic Fibrosis System

Business Wire

SAN DIEGO -- July 1, 2013

Illumina, Inc. (NASDAQ:ILMN) today announced that it declared conformity with
the requirements of the IVD Directive on June 26, 2013 and has applied the CE
mark for the MiSeqDx Cystic Fibrosis System. The company is finalizing plans
to commercialize the product in a number of European countries that require CE
marking. The MiSeqDx Cystic Fibrosis System consists of the MiSeqDx
next-generation sequencing instrument, two assays (the MiSeqDx Cystic Fibrosis
Diagnostic Assay and the MiSeqDx Cystic Fibrosis Carrier Screening Assay), and
associated software. Developed for the clinical molecular diagnostics market,
the system leverages Illumina’s targeted resequencing chemistry to provide
rapid and accurate identification of variants in the cystic fibrosis
transmembrane conductance regulator (CFTR) gene.

The MiSeqDx Cystic Fibrosis Diagnostic Assay provides highly accurate and more
actionable clinical information than cystic fibrosis genotyping assays
previously available in Europe and offers a comprehensive view of all CFTR
variants present in patient samples. The MiSeqDx Cystic Fibrosis Carrier
Screening Assay is designed for simultaneous detection of 162
functionally-verified, clinically-relevant variants within the CFTR gene,
including all those currently recommended for carrier screening purposes in
U.S. guidelines developed by the American College of Medical Genetics (ACMG)
and the American Congress of Obstetricians and Gynecologists (ACOG).

“The MiSeqDx Cystic Fibrosis System empowers more precise medicine, and
shortens the path to a clinical diagnosis, by sequencing the entire CFTR
gene,” said Greg Heath, Senior Vice President and General Manager of the
Illumina Diagnostics business. “The system provides clinicians and genetic
counselors more definitive results to inform patient care. Now that we have
achieved this regulatory milestone, the MiSeqDx will serve as the foundation
for future Illumina and partner-developed content. We plan to expand our
offering with additional assays.”

Cystic fibrosis is a life-threatening, inherited single-gene disorder that
affects more than 70,000 people worldwide. Caused by mutations in the CFTR
gene, the disease has a wide clinical presentation depending on which CFTR
gene mutations are present. Most CFTR mutations are rare, and their
distribution and frequency vary among different world populations.

The MiSeqDx Cystic Fibrosis System will be available for order in Europe
beginning in July 2013. For more information, please visit:

About Illumina

Illumina ( 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


Illumina, Inc.
Rebecca Chambers
Jennifer Temple
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