NIH has published a call for applications for a new R21/R33
grant titled Innovative Technologies for Differential Diagnosis of Acute
Febrile Illnesses (RFA-AI-14-062). For full RFA click here.
The purpose of this Funding Opportunity Announcement (FOA)
is to solicit applications for early-stage translational research projects
focused on the development of innovative, unbiased next generation,
differential diagnostic technologies for acute febrile illnesses caused by
infectious pathogens, excluding HIV.
Dates:
- Letter of intent due date: January 2, 2015
- Application due date: February 2, 2015
- Earliest project start date: December 2015
Award budget:
Support for the R21 phase is limited to $275,000 in
direct costs over the R21 two-year project period, with a maximum of $200,000
in direct costs allowed in any single year. The R33 award phase is limited to
$300,000 in direct costs per year.
Research Objectives and Scope
This Funding Opportunity Announcement (FOA) will provide
support for research projects to establish proof-of-concept for novel, rapid
and innovative medical diagnostic technologies and/or early-stage product
development activities. The primary goal of such a diagnostic is to initiate
appropriate therapeutic treatment during the initial visit for patients
presenting acute fever in any point-of-care setting.
Research objectives may include the initial development of a
novel technology or adaptation of an emerging technology to detect pathogens
associated with acute febrile illnesses. Detection of host factors that would
provide a differential diagnosis of bacterial infection that may provide
clinically actionable information may also be included. A principal objective
of this FOA is the development of innovative and novel diagnostic technologies.
The following research areas are of particular interest:
- Technologies that analyze clinical samples more accurately and rapidly than current diagnostic platforms and have utility within, or provide improvements upon, current clinical care and treatment.
- Technologies capable of measuring in vivo analytes.
- Integrated sample-to-answer sequencing-based platforms.
- Diagnostic platforms that simultaneously detect multiple biomarkers.
For this FOA, the proposed diagnostic must be
incubation-independent (i.e. designed to detect pathogens without requiring
culture-bottle and/or streak plate incubations). Assays that can distinguish
simultaneously between classes of pathogens (e.g. bacterial versus viral) are
encouraged. At the end of the project period, a successful project will have
demonstrated proof of principle with the capability of the developed technology
to detect targeted pathogens in relevant live animal infection models (for in
vivo detection technologies) or human clinical samples.
For the purpose of this FOA, the following features are of
greatest importance for a proposed diagnostic:
- Rapid: a target diagnostic test time of <1 hour to final result, including time required for clinical sample processing (if appropriate).
- Culture independent: the diagnostic should focus on direct detection of pathogens or other biomarkers from human clinical samples.
- Sensitive: the sensitivity should be equivalent to or exceed that of FDA-cleared diagnostics for proposed agent(s) from the same sample type.
- Specific: the specificity should be equivalent to or exceed that of FDA-cleared diagnostics for proposed agent(s) from the same sample type.
- Easy to use: for example, an integrated, closed sample-to-answer system with automated data analyses and/or result presentation and with minimal operator training and expertise required.
- Cost-effective: projected production and operating costs should be as inexpensive as possible.
