A Medical Device Daily

Applied Biosystems (Foster City, California, a business of Applera , reported that the U.S. Department of Defense (DoD) has awarded it a $24.5 million contract to push the development of a prototype instrument system to improve the way infectious diseases are identified for epidemiological and biosecurity purposes.

The system will be designed to give reproducible results in less than one hour following sample processing via streamlined workflow and the ability to simultaneously analyze multiple pathogen targets in a single test.

Applied Bio said that last month it presented key components of the prototype to the U.S. Air Force, which will be responsible for validating the next-generation pathogen identification system.

By developing a system simplifying the processing and analysis of pathogen detection tests, Applied Bio said it expects to enable a new generation of decentralized molecular detection systems that can be deployed in diverse locations and operated by a broader range of public health and safety professionals. The new systems are also will have a modular design enabling rapid customization of new test panels to detect emerging pathogens.

It said early prototypes have demonstrated the ability to identify up to 10 pathogens simultaneously on a credit card-sized test array and are expected to provide more detailed information about the nature of each sample.

In other grant news:

• GeneGo (St. Joseph, Michigan), a provider of databases, software and services in systems biology, reported receiving a $750,000 Phase II SBIR grant from the DoD to develop a systems biology suite for functional analysis of proteomics data. In Phase II, GeneGo will adapt its data-mining platform, MetaCore for handling different types of proteomics data and implement new algorithms for reconstruction of protein-state specific biological networks and pathways.

GeneGo will work in collaboration with Professor Austin Yang's group from the University of Southern California (Los Angeles), Rosetta Biosystems (Seattle) and the Michigan Proteome Consortium (Ann Arbor).

GeneGo develops systems biology technologies, its first platform allowing an integration and analysis of different kinds of experimental data (mRNA expression, proteomics, metabolites, phenotypic data) and active chemistry (metabolites, drugs, other xenobiotics) within the framework of biological pathways and networks. The company's first product, MetaCore, assists in target selection and validation, identification of biomarkers for disease states and toxicology.

• Affiliated Computer Services (Dallas), a provider of business process outsourcing and

information technology solutions, reported signing a two-year, $19.9 million contract with the South Carolina Department of Health and Human Services (SCDHHS; Columbia). The contract includes options for three, one-year extensions.

ACS will provide third-party liability (TPL) insurance verification, benefit recovery, and health insurance program administration services. ACS also will develop a new electronic imaging, workflow and data entry system. And it will provide consultative services to SCDHHS for identifying and verifying new payers and for cost avoidance and cost recovery processes.

ACS reports supporting more than 20 million program recipients and processes nearly 475 million Medicaid healthcare claims annually, representing more than $47 billion in provider payments.

Briefly Noted

Clinical Data to discuss testing regulation

Clinical Data (Newton, Massachusetts) said it has received a letter from the FDA regarding the regulation of genetic testing.

The letter invited the company to meet with the FDA to discuss the nature and appropriate regulatory status of the company's tests and, if any regulatory requirements apply, the least burdensome ways that the company may fulfill them. Clinical Data said it would meet with the FDA “in the near future.”

The company said it will be reviewing the regulatory status for all tests conducted on behalf of end-users including Familion, its CLIA-certified test for cardiac channelopathies that requires a prescription by healthcare providers.

Clinical Data notes that while it conducts DNA assays for one nutrigenomic test on behalf of a third party customer, the test is not marketed by the company and revenue from this test is not material to its business.

The company said it believes it is in compliance with all applicable state and federal regulations and will continue to work with the appropriate regulatory agencies to remain so.