A Medical Device Daily Staff Report

Illumina (San Diego) said it was awarded a contract from the 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 said it 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.

Illumnia says by 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 GM 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 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.

Illumina makes life science tools and integrated systems for the analysis of genetic variation and function.

In other agreements/contracts news:

• GE Healthcare (Chalfont, UK) said it is joining with RadNet (Los Angeles), a network of outpatient diagnostic imaging centers, to pilot its Best Pathways initiative, a breast cancer detection optimization model. GE Healthcare and RadNet will evaluate the clinical breast cancer detection process to quantify inefficient diagnostic patterns and identify optimal paths to lower cost and improve patient outcomes. This program will focus on subpopulations of women in which guidelines are lacking and substantial variability is observed in clinical practice.

Best Pathways is designed to address what the companies call a significant need for increased insight into the breast cancer detection process – from a patient's initial screening mammogram to final biopsy. Historically, diagnostic processes have been variable and inefficient, leading to frequent false-positive test results and costly follow-up imaging procedures.

GE Healthcare and RadNet will identify and quantify diagnostic costs per cancer detected, the types of breast cancer detected and their stage distribution, the number of imaging tests and biopsies required to detect each cancer, and the incremental cost-effectiveness ratios for each diagnostic case.

• NextGen Healthcare Information Systems (Horsham, Pennsylvania), a subsidiary of Quality Systems and a provider of healthcare information systems and connectivity solutions, said that CommUnityCare (Austin, Texas) has selected NextGen Healthcare to provide revenue cycle management services (RCM).

CommUnity Care, a nonprofit Federally Qualified Health Center (FQHC) system that operates 22 clinics throughout Austin/Travis County in Texas, will deploy NextGen RCM Services throughout its enterprise. These services will integrate with the organization's current supply of NextGen Healthcare technology, including NextGen Ambulatory EHR and NextGe Practice Management.

• RaySearch Laboratories (Stockholm, Sweden) said it has received an order for its RayStation treatment planning system from First Coast Oncology (Jacksonville, Florida).

First Coast Oncology is comprised of three locations in Northeast Florida and is dedicated to providing patients with the most advanced radiation oncology treatments available for all types of cancer, in a compassionate and respectful environment.

RayStation will be implemented for clinical use at First Coast Oncology in conventional radiation treatment planning beginning in the fourth quarter of this year. This will include IMRT with multi-criteria optimization, as well as cutting edge technologies such as full deformable registration and adaptive re-planning.

RayStation integrates all RaySearch's advanced treatment planning solutions into a treatment planning system. It combines unique features such as multi-criteria optimization tools with full support for 4-D adaptive radiation therapy.

The Premier (Charlotte, North Carolina) healthcare alliance reported new agreements for plasticware and glassware – research have been awarded to BioMed Resource (Riverside, California); Grenier Bio-One North America (Monroe, North Car olina); and Sarstedt (Newton, North Carolina).

Premier operates a healthcare purchasing network.

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