Illumina Awarded FDA Contract for Next Generation Sequencing (NGS) Technology to Identify Foodborne Pathogens

  Illumina Awarded FDA Contract for Next Generation Sequencing (NGS)
  Technology to Identify Foodborne Pathogens

   Agency Selects MiSeq® System for Program to Explore NGS as Mechanism to
                             Enhance Food Safety

Business Wire

SAN DIEGO -- September 18, 2012

Illumina, Inc. (NASDAQ:ILMN) today announced it was awarded a contract from
the U.S. Food and Drug Administration (FDA) to provide the agency with MiSeq
sequencing systems and reagents for conducting whole genome analysis on
produce and produce-related environmental Salmonella and shigatoxigenic E.
coli isolates. The contract is worth up to $17 million over a period of five

The FDA currently has several MiSeq systems already deployed and is building
its existing capacity to provide resources and training to enhance whole
genome sequencing capabilities as part of a proof-of-concept initiative. More
immediately, the agency is looking to collect data that is crucial to source
tracking Salmonella that may be involved in future produce-related outbreaks.

Using MiSeq, the FDA’s national and state laboratories, where numerous and
diverse enteric pathogens are detected, isolated and processed, will be able
to generate high-quality whole genome sequences from historical pathogen
collections and from bacteria collected from produce sources across the
country. Sequencing data will be uploaded real-time to the National Center for
Biotechnology Information (NCBI) curated database, thereby enhancing the
database’s power for source tracking queries. This data will serve as early
proof-of-concept for rapid networking of resources using a whole genome
sequencing based approach to pathogen detection, identification and traceback.

“Illumina applauds the FDA’s commitment to improving the public’s safety from
foodborne illness outbreaks, as demonstrated by its decision to further
integrate whole genome sequencing into its efforts,” said Christian Henry, SVP
and General Manager of Illumina’s Genomic Solutions business. “We are
extremely pleased MiSeq was selected as the technology platform for this
large-scale initiative. We are well-positioned to deliver on the program’s
requirements, based on MiSeq’s rapid turnaround time, unmatched accuracy, and
ease-of-use, as well as our proven track record.”

Sequencing provides accurate subtyping and cluster analysis for investigating
food-borne outbreaks and traceback to the food or environmental source.
However, conventional molecular typing tools lack the resolution for
differentiating tightly linked bacterial isolates and provide limited genetic
differentiation of certain strains such as Salmonella. MiSeq is ideally suited
for screening bacterial pathogens due in part to its speed, simple workflow,
high resolution, and accuracy, which enhance the ability to identify close
related bacterial isolates.

This project supports FDA’s mission of protecting public health by generating
baseline data to identify and remove contaminated produce from the nation’s
food supply. Currently Salmonella is the leading cause of food-borne illness
in the United States.

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.
Scott Dawson, 858-882-6665
Jennifer Temple, 858-882-6822
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