Illumina lands FDA contract

SAN DIEGO—Illumina, Inc. has been awarded a contract fromthe U.S. Food and Drug Administration (FDA) to provide next-generationsequencing in the effort to identify foodborne pathogens. Under the contract,Illumina will provide the FDA with MiSeq sequencing systems and reagents forperforming whole-genome analysis on produce and produce-related environmentalSalmonella and shigatoxigenic E. coli isolates. The contract will total up to$17 million over the course of five years.

MiSeq, Illumina's fully integrated personal sequencer,offers a sequencing solution from rapid sample prep through automated dataanalysis and storage in the cloud, enabling users to move cover sequencingpreparation, running and analysis in just eight hours. The FDA uses several MiSeqsystems already, and is furthering its ability to offer resources and trainingto develop whole-genome sequencing capabilities as part of a proof-of-conceptinitiative. In the short term, the FDA hopes to collect data that will enablebetter source tracking of Salmonella, which remains the leading cause offood-borne illness in the United States.

"Illumina applauds the FDA's commitment to improving thepublic's safety from food-borne illness outbreaks, as demonstrated by itsdecision to further integrate whole genome sequencing into its efforts,"Christian Henry, senior vice president and general manager of Illumina'sGenomic Solutions business, said in a press release. "We are extremely pleasedMiSeq was selected as the technology platform for this large-scale initiative.We are well positioned to deliver on the program's requirements, based onMiSeq's rapid turnaround time, unmatched accuracy and ease-of-use, as well asour proven track record."

The use of Illumina's MiSeq system will allow the FDA'slibraries to generate high-quality whole genome sequences from both historicalpathogen collections and from bacteria gathered from produce sources. Thesequencing data that results will be uploaded real-time to the National Centerfor Biotechnology Information curated database, which will bolster thedatabase's ability to perform source tracking searches. The data will also beused as an early proof of concept for the rapid networking of resources using awhole genome sequencing-based approach to the detection, identification andtrackback of pathogens. Sequencing offers accurate subtyping and clusteranalysis in the investigation of food-borne outbreaks and for tracking theoutbreak back to its food or environmental source, and Illumina's system in particularenables the screening of bacterial pathogens given its speed, high resolutionand accuracy, which makes it easier to identify closely related bacterialisolates.

The contract comes on the heels of an announcement ofanother expansion to Illumina's sequencing offerings. The company has announcedthe launch of its TruSeq Stranded mRNA and Total RNA Sample Preparation Kitsfor RNA sequencing. The kits allow researchers to conduct gene expressionstudies quickly and easily, providing complete views of transcriptomes evenfrom low-quality RNA samples such as formalin-fixed paraffin-embedded samples.

SOURCE: Illumina press release