Trends & Perspectives

Published: May 1, 2009
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NIH offers grant funding for IVDs

By: Richard Park






As part of the American Recovery and Reinvestment Act that was passed by Congress and signed into law by President Obama in February, NIH has designated for the next two years at least $200 million for a new initiative called the NIH Challenge Grants in Health and Science Research. This initiative will fund 200 or more grants, contingent upon the submission of a sufficient number of scientifically meritorious applications. In addition, the Recovery Act funds allocated to NIH specifically for comparative effectiveness research may be available to support additional grants.


This program will support research on various challenge areas addressing specific scientific and health challenges in biomedical and behavioral research, which will benefit from significant two-year jump-start funds. The range of challenge areas NIH has identified focuses on specific knowledge gaps, scientific opportunities, new technologies, data generation, and research methods that would gain from an influx of funds to advance quickly the areas in significant ways. Within each broad challenge area, the NIH institutes, centers, and offices have specified particular challenge topics that address their missions.


For example, under the Recovery Act, the National Institute of Biomedical Imaging and Bioengineering (NIBIB) is participating in an NIH-established program called the Research and Research Infrastructure Grand Opportunities, or the GO grants program. This new program will support projects that address large biomedical and behavioral research endeavors that will benefit from receiving two-year funding without the expectation of continued NIH support beyond that time frame.


According to NIBIB, the research supported by the GO grants program should have a high impact on and a high likelihood of enabling growth and investment in biomedical research and development, public health, and healthcare delivery. The GO grants program will support large-scale research projects that accelerate critical breakthroughs, early and applied research on cutting-edge technologies, and new approaches to improve the synergy and interactions among multi- and interdisciplinary research teams.


NIBIB has two specific challenge grant topics that cover the development of IVDs: the development of biomedical technologies and systems (06-EB-102) and point-of-care (POC) technologies (06-EB-107). The focus areas under the development of biomedical technologies and systems challenge topic include the following: providing immediate diagnostic information for multiple conditions at the point of care; a robust, consistently accurate glucose sensor with extended functional lifetime, improved accuracy, and low variability of readings; and low-cost diagnostic or therapeutic systems.


For the POC technologies challenge topic, NIBIB believes that despite recent interest in advancing the field of POC testing, major challenges remain in developing new POC technologies, including a clinical needs-driven approach, appropriate clinical testing of prototype devices, and connectivity to health information systems. Multidisciplinary technology development efforts are required to facilitate device design that is appropriate for a given healthcare setting with the potential to affect significantly the delivery of healthcare in low-resource or remote settings.


“It should be noted that these topics are not limited to IVDs, but can include the development of other POC-related technologies, such as noninvasive monitoring and low-cost imaging, as an example,” says Brenda Korte, PhD, program director of NIBIB's division of discovery science and technology. “There is no prioritization on disease or condition in these topic areas, although each does encourage the development of complete systems with an emphasis on use in low-resource settings. IVD development is also covered under the health disparities challenge area as well as challenge topics from other institutes. NIBIB also supports nanotechnology research and sensor development that can affect future IVD development. Besides challenge awards, we are also inviting supplements to existing NIBIB awards and competing revisions of existing grants in these areas. Finally, POC has been identified as a NIBIB priority area for the GO grant applications.”


Korte said that NIBIB intentionally made the IVD-related challenge topics broad in order to encourage the best ideas from the IVD industry.


“There is a perceived gap in the development of complete systems that are appropriate for the intended healthcare settings, from the perspective of performance, cost, usability, etc.,” says Korte. “As such, one goal is to expand on the development of component technologies to address the challenges of the analysis of complex clinical samples and system integration, with a clearer definition of clinical needs and the establishment of appropriate partnerships to put the technology development efforts in context.”


Additional information about these and other grant funding opportunities can be accessed via NIH's Web site at



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