Illumina won a potentially $17 million, five-year contract to provide FDA with its MiSeq sequencing systems and reagents for conducting whole-genome analyses on produce and produce-related environmental isolates of Salmonella and shigatoxigenic E. coli. The firm says the agency already has a number of MiSeq systems, and is expanding its capacity for whole-genome sequencing as part of a proof-of-concept initiative.
In the short term FDA wants to collect data that will help source track Salmonella that may be involved in future produce-related outbreaks. However, the agency plans on using the systems at its national and state laboratories to generate whole-genome sequences from historical pathogen collections as well as from isolates collected from produce sources across the U.S. The resulting sequencing data will be added to the National Center for Biotechnology Information database as it is generated, and serve to demonstrate the ability for rapid networking of resources using whole-genome sequencing approaches to pathogen detection, identification, and tracking.
Illumina says conventional molecular-typing tools don’t have the resolution required to delineate between tightly linked bacterial isolates, and thus provide only a limited ability to genetically differentiate strains of some key bacteria, such as Salmonella, which is the leading cause of food-borne illness in the U.S. In contrast, the firm claims, MiSeq is ideally suited for screening bacterial pathogens. "We are extremely pleased MiSeq was selected as the technology platform for this large-scale initiative,” remarks Christian Henry, svp and general manager for Illumina’s genomic solutions business. “We are well-positioned to deliver on the program's requirements, based on MiSeq's rapid turnaround time, unmatched accuracy, and ease-of-use."