NEW YORK (GenomeWeb News) – The National Institute of Allergy and Infectious Diseases plans to spend up to $20 million in fiscal year 2014 to fund efforts to develop lead candidates for diagnostics, therapeutics, and vaccines, that can be used as biodefense countermeasures against certain pathogens and toxins.
Investigators in these 10 to 15 projects will pursue clinical development of lead candidates that have already been identified and have generated proof-of-concept data. They will engage in lead optimization, efficacy and stability testing, efforts to adapt them specifically for biodefense applications and to scale up their production, and a range of similar types of studies.
NIAID wants to fund development of diagnostics that can swiftly identify Category A, B, or C pathogens and toxins — and their resistance profiles — from a diverse range of clinical samples, including swabs, sputum, blood, serum, stool, and urine, and others.
The categories are based on how much of a risk they pose to national security and public health.
The institute seeks, in particular, to encourage development of multiplexed diagnostics that can deliver information on early, non-specific symptoms. Another high priority area is diagnostics that use platforms that simultaneously detect multiple agents and their drug sensitivities in clinical specimens and which can quickly differentiate individuals who are infected with a biological agent from those who have more common infections.
The ultimate aim is that these devices will be developed with the goal of gaining clearance from the US Food and Drug Administration, although FDA clearance does not need to be the final result of these specific research project periods, NIAID said.
NIAID wants these diagnostics to shorten the time required for diagnosis and speed up sample processing; to be at least as sensitive and specific as current FDA-cleared tests; to be easy to use and cost-effective; and to be adaptable so that they may integrate new diagnostic tests for new pathogens and to detect modified or new targets.
These diagnostics projects may pursue a wide range of activities, including the development of tools that are capable of high-throughput multiplex screening using biomarkers or analytes to identify human responses to infection; high-throughput robotics and automated data outputs and analyses tools; integrated technologies that use multiple methods of parallel measurements in the same platform, such as detecting nucleic acids, proteins, and other targets all in the same assay; tools that can resolve acquired genetic traits in micro-organisms such as patterns of microbial resistance or enhanced virulence; nanotechnology or microfluidic systems to process large numbers of patient samples, and others.