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Illumina Awarded FDA Contract For Next Generation Sequencing (NGS) Technology To Identify Foodborne Pathogens

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 years.

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 release.

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