Opportunity Information: Apply for PA 14 101
Apply for PA 14 101
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Innovative Technologies and Assays in Support of HIV Cure Research (ITAS Cure) (R43/R44)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.286 Discovery and Applied Research for Technological Innovations to Improve Human Health 93.855 Allergy and Infectious Diseases Research 93.856 Microbiology and Infectious Diseases Research 93.859 Biomedical Research and Research Training.
- This funding opportunity was created on Feb 13, 2014 and posted on Feb 13, 2014.
- Applicants must submit their applications by Jan 7, 2017. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Small businesses.
- Other Eligible Applicants include the following Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, may be allowed.
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Opportunity Summary:
Innovative Technologies and Assays in Support of HIV Cure Research (ITAS Cure) (R43/R44), Funding Opportunity Number PA 14-101, is an NIH Small Business Innovation Research (SBIR) grant program designed to push forward practical, commercially viable tools that can measure and characterize the persistent HIV reservoir in people living with HIV who are on effective antiretroviral therapy. The core problem the FOA is trying to solve is that standard clinical viral load tests often cannot detect the tiny amounts of virus or infected cells that remain after treatment, and the field needs better ways to find, quantify, and track those reservoirs over time if HIV cure strategies are going to be evaluated accurately. This program supports small businesses developing next-generation assays, analytical methods, and imaging approaches that can provide a more precise, dynamic picture of residual infection.
The FOA specifically calls for sensitive and quantitative technologies, including laboratory assays, measurement methods, and imaging techniques. A major emphasis is placed on tools that can either quantify replication-competent virus (virus that can actually restart infection) or measure integrated provirus (viral DNA integrated into the host genome), because distinguishing between harmless viral remnants and truly dangerous, rebound-capable infection is central to cure research. NIH also highlights interest in technologies that can identify or distinguish HIV-infected cells directly within tissues (in situ), which is important because reservoirs are not uniformly distributed in the body and can behave differently depending on anatomical location and cell type. Imaging agents or probes, as well as novel applications of existing imaging platforms, are explicitly within scope if they improve reservoir detection or measurement.
Beyond simply detecting HIV persistence, the program is looking for meaningful performance gains over existing methods. Applications are expected to propose tools that offer substantially improved sensitivity (finding smaller amounts of virus or fewer infected cells), better reproducibility (consistent results across runs, sites, and operators), improved spatiotemporal resolution (pinpointing where reservoirs are and how they change over time), and/or greater scalability (ability to process more samples, work in higher throughput, or be deployed more broadly). NIH also wants methods that help characterize the replicative capacity of infected cells and tissues, meaning the technology should help clarify whether what is being measured represents virus capable of propagating versus inactive or defective forms. The larger goal is to enable a fine-grained, real-time understanding of reservoir dynamics so researchers can judge whether an intervention is shrinking the reservoir, altering its biology, or simply changing what is easiest to measure.
In addition to wet-lab and imaging innovations, the FOA emphasizes quantitative methods and analytical tools that can assess viral load in a reproducible way, whether the target is replication-competent virus or integrated proviral DNA. This reflects an interest not only in raw detection instruments or assays, but also in the measurement frameworks and analysis pipelines that make results comparable and reliable across studies. Tools that support consistent monitoring of changes in persistent infection over time are especially aligned with the FOA, because cure-directed clinical studies need standardized and dependable endpoints to interpret whether a candidate therapy is truly having an effect.
From an administrative and eligibility standpoint, this is a discretionary NIH grant opportunity using the SBIR mechanism under R43/R44, which generally corresponds to phased small business development (with feasibility and development stages). The eligible applicants are small businesses; non-U.S. (foreign) institutions are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. However, foreign components, as defined by NIH policy, may be allowed in certain circumstances. There is no cost-sharing or matching requirement. The opportunity was posted on February 13, 2014, with an original and final closing date listed as January 7, 2017, and it was archived on February 7, 2017. Programmatic areas connected to the opportunity span NIH interests in technological innovation for health improvement and infectious disease research, reflected in CFDA listings 93.286, 93.855, 93.856, and 93.859.
In practical terms, the ITAS Cure FOA is aimed at bridging the gap between cutting-edge HIV reservoir science and deployable products: assays, imaging probes, measurement systems, and analytical methods that can be used by researchers and, ultimately, in clinical research settings. The explicit requirement for commercial potential signals that NIH is looking for tools that will not only advance knowledge but can realistically become widely available technologies to support the broader HIV cure research ecosystem.
Frequently Asked Questions (FAQs): Innovative Technologies and Assays in Support of HIV Cure Research (ITAS Cure) (R43/R44) - PA 14-101
What is the ITAS Cure (R43/R44) funding opportunity?
Innovative Technologies and Assays in Support of HIV Cure Research (ITAS Cure) (R43/R44), Funding Opportunity Number PA 14-101, is an NIH Small Business Innovation Research (SBIR) program that supports small businesses developing practical, commercially viable technologies to measure and characterize persistent HIV reservoirs in people living with HIV who are on effective antiretroviral therapy.
What problem is this FOA trying to solve?
The FOA targets a key barrier in HIV cure research: standard clinical viral load tests often cannot detect the tiny amounts of virus or infected cells that can remain after treatment. Because these residual reservoirs can drive viral rebound, the field needs better tools to find, quantify, and track them over time to accurately evaluate HIV cure strategies.
What kinds of technologies are within scope for ITAS Cure?
The FOA calls for sensitive and quantitative technologies, including laboratory assays, measurement methods, analytical approaches, and imaging techniques that improve detection and measurement of HIV persistence. The scope explicitly includes imaging agents or probes and novel applications of existing imaging platforms if they improve reservoir detection or measurement.
Does this program focus only on wet-lab assays?
No. While wet-lab assays are clearly within scope, the FOA also emphasizes quantitative methods and analytical tools (including measurement frameworks and analysis pipelines) that make results reproducible and comparable across studies, as well as imaging approaches that can help detect or characterize reservoirs.
Why does the FOA emphasize measuring the HIV reservoir?
Accurate reservoir measurement is central to HIV cure research because it helps determine whether an intervention is actually shrinking the reservoir, changing its biology, or merely altering what is easiest to detect. The FOA aims to enable a fine-grained, dynamic understanding of reservoir behavior over time.
What is meant by the "persistent HIV reservoir" in this FOA?
In the context provided, the persistent reservoir refers to the small amount of virus or infected cells that remain in people on effective antiretroviral therapy. These reservoirs may be below the detection limits of standard clinical viral load tests but are important because they can be related to viral rebound and ongoing persistence.
What specific measurement targets are highlighted as high priority?
The FOA places major emphasis on tools that can quantify replication-competent virus (virus capable of restarting infection) and/or measure integrated provirus (viral DNA integrated into the host genome). Distinguishing between harmless viral remnants and rebound-capable infection is described as central to cure research.
What does "replication-competent virus" mean in this opportunity?
Replication-competent virus is described as virus that can actually restart infection. Technologies that can quantify this form of virus are emphasized because they help identify infection that is truly capable of rebounding.
What does "integrated provirus" mean in this opportunity?
Integrated provirus refers to viral DNA that is integrated into the host genome. The FOA highlights measurement of integrated provirus as a key target for distinguishing different forms of persistent infection and for tracking reservoirs in cure studies.
Why is it important to distinguish harmless viral remnants from dangerous, rebound-capable infection?
The FOA frames this distinction as essential because cure strategies need to be evaluated against the forms of persistence that can drive rebound. Tools that clarify whether a signal represents replication-capable virus versus inactive or defective forms help make study endpoints more meaningful.
Are tissue-based (in situ) detection approaches encouraged?
Yes. NIH highlights interest in technologies that can identify or distinguish HIV-infected cells directly within tissues (in situ). This matters because reservoirs are not uniformly distributed in the body and may behave differently depending on anatomical location and cell type.
Are imaging methods eligible under this FOA?
Yes. Imaging techniques are within scope, including imaging agents or probes and novel applications of existing imaging platforms, provided they improve reservoir detection or measurement and support the FOA's goals around sensitivity, quantification, and characterization.
What kinds of performance improvements does NIH expect compared to existing methods?
The FOA indicates that applicants are expected to propose meaningful gains over existing methods, such as substantially improved sensitivity, better reproducibility across runs/sites/operators, improved spatiotemporal resolution (where reservoirs are and how they change over time), and/or greater scalability (higher throughput or broader deployability).
What does "spatiotemporal resolution" mean in the context of this FOA?
As described, spatiotemporal resolution refers to the ability to pinpoint where reservoirs are located (spatial detail, including tissues and anatomical sites) and how they change over time (temporal tracking), supporting a more dynamic picture of residual infection.
What does "scalability" refer to for proposed technologies?
Scalability is described in practical terms as the ability to process more samples, operate in higher throughput, or be deployed more broadly. The FOA is looking for tools that can move beyond boutique use and support broader research and clinical research needs.
Does the FOA support technologies that characterize whether infection is capable of propagating?
Yes. NIH wants methods that help characterize the replicative capacity of infected cells and tissues, meaning the technology should help clarify whether what is measured represents virus capable of propagating versus inactive or defective forms.
Is this FOA interested in standardized monitoring over time?
Yes. Tools that support consistent monitoring of changes in persistent infection over time are described as especially aligned, because cure-directed clinical studies need standardized and dependable endpoints to interpret whether a candidate therapy is truly having an effect.
Who is eligible to apply?
Eligible applicants are small businesses. The opportunity uses the NIH SBIR mechanism under R43/R44, which is generally associated with phased small business development (feasibility and development stages).
Are non-U.S. (foreign) institutions eligible to apply?
No. The FOA states that non-U.S. (foreign) institutions are not eligible to apply.
Are non-U.S. components of U.S. organizations allowed?
No. The FOA indicates that non-U.S. components of U.S. organizations are also not eligible.
Are foreign components allowed in any circumstances?
Potentially. The FOA notes that foreign components, as defined by NIH policy, may be allowed in certain circumstances.
Is cost-sharing or matching required?
No. The FOA states there is no cost-sharing or matching requirement.
What grant mechanism does this opportunity use?
This is a discretionary NIH funding opportunity using the SBIR mechanism under R43/R44, which generally corresponds to phased small business development (often described as feasibility and development stages).
What does the FOA say about commercial potential?
The opportunity explicitly requires commercial potential, signaling that NIH is looking for tools that can realistically become widely available products to support the broader HIV cure research ecosystem, not just one-off research demonstrations.
When was this funding opportunity posted, and what were the closing dates?
The FOA was posted on February 13, 2014. The original and final closing date listed is January 7, 2017, and the opportunity was archived on February 7, 2017.
What is the Funding Opportunity Number and title?
The Funding Opportunity Number is PA 14-101, and the title is Innovative Technologies and Assays in Support of HIV Cure Research (ITAS Cure) (R43/R44).
What CFDA program areas are associated with this opportunity?
The FOA references CFDA listings 93.286, 93.855, 93.856, and 93.859, reflecting NIH interests in technological innovation for health improvement and infectious disease research.
What is the practical goal of ITAS Cure for the HIV cure research field?
In practical terms, the FOA aims to bridge cutting-edge HIV reservoir science and deployable technologies by supporting assays, imaging probes, measurement systems, and analytical methods that can be used by researchers and ultimately in clinical research settings.
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