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NIAID to Fund Biodefense Dx Development Projects

NEW YORK (GenomeWeb News) – The National Institute of Allergy and Infectious Diseases will spend $9.3 million in Fiscal Year 2013 to fund research and development of new diagnostic and therapeutic countermeasures for use in biodefense efforts against dangerous pathogens and toxins.

The new grants will support between 10 and 15 projects that are focused on preclinical development of medical diagnostics or lead candidate therapeutics, which have received a substantial investment from at least one industry partner. That investment may not necessarily be financial, but could include a commitment of resources such as support for product development, personnel, and in kind contributions of materials and/or reagents.

Applicants for these grants, which will provide up to $750,000 per year, must propose a project aimed at advancing a lead therapeutic or diagnostic candidate that has already been identified, but it is not necessary that these projects result in a final product or even reach readiness for clinical trials or validation. While clinical development strategies may be included within an overall project, these grants will not support clinical trials.

In addition, NIAID said that applicants may request up to $300,000 for major equipment to ensure that research aims can be met and biohazards can be contained. Such requests must be included in the first year requested budget with justification, and are in addition to the $750,000 direct cost limit.

NIAID sees a need for diagnostics to identify infectious agents or toxins rapidly and in a range of clinical samples including blood, sputum, serum, CSN, urine, and others, from individuals at multiple stages of infection.

These diagnostic tests also should be cost-effective, easy to use, adaptable for new agents or targets, and must be able to meet the specificity the Food and Drug Administration requires for tests for these agents.

The diagnostic platforms or technologies that these tests are based on may include, but are not limited to integrated tools capable of high-throughput multiplex screening using biomarkers or analytes to identify human immune or other physiological response to infection; methods capable of high-throughput, robotics, automated data output, and analyses; technologies capable of resolving engineered or otherwise acquired genetic traits in microorganisms, such as microbial resistance or enhanced virulence; and tests that use multiple methods of parallel measurements for detection in one platform, such as detecting nucleic acids, proteins, and other targets from multiple agents in the same assay.

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