Opportunity Information: Apply for PA 14 102

  • 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) (R41/R42)" 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:

The Innovative Technologies and Assays in Support of HIV Cure Research (ITAS Cure) (R41/R42) opportunity, Funding Opportunity Number PA 14-102, is a National Institutes of Health (NIH) Small Business Technology Transfer (STTR) grant program designed to push forward practical, commercialization-ready tools that can measure and characterize the persistent HIV reservoir in people living with HIV who are taking effective antiretroviral therapy. The central problem this program targets is that, even when standard clinical tests show viral suppression, small amounts of virus can remain hidden in cells and tissues. Those reservoirs are the major barrier to an HIV cure, and they are difficult to quantify with existing methods. NIH is using this FOA to encourage small businesses to create next-generation technologies that can detect, measure, and track these reservoirs more accurately and more consistently than what is currently available.

A key focus of the FOA is the development of highly sensitive and quantitative assays, methods, and imaging techniques that can be applied directly to measuring residual HIV in treated individuals. The announcement explicitly welcomes both entirely new technologies and novel applications of existing platforms, including the creation or innovative use of imaging agents or probes. NIH signals particular interest in tools that go beyond simply detecting HIV genetic material and instead can quantify replication-competent virus (virus that can actually reproduce and cause rebound) or measure integrated provirus (viral DNA that has been inserted into the host genome). Another emphasized priority is the ability to distinguish HIV-infected cells in situ, meaning within their natural tissue context, which is important for understanding where reservoirs persist and how they behave over time.

The program also lays out clear performance expectations: proposed technologies should meaningfully outperform existing methodologies by delivering substantially improved sensitivity and quantitative reliability, better reproducibility across runs and across sites, improved spatiotemporal resolution (the ability to locate infected cells or signals precisely in space and track changes over time), and/or better scalability for broader use. NIH wants these tools to enable a more fine-grained and dynamic picture of persistent infection, rather than a coarse snapshot. In practice, this means the ideal deliverables are not only capable of finding rare infected cells or low-level signals, but can do so consistently, with a strong quantitative backbone, and in a way that can be deployed in real-world research settings and eventually in a commercial product context.

In addition to wet-lab assays and imaging, the FOA highlights the importance of quantitative methods and analytical tools for reproducible assessment of viral burden. This includes analytical approaches that can track viral load related to replication-competent virus or integrated provirus over time so researchers can monitor dynamic changes in persistent infection. This emphasis reflects a broader need in HIV cure research: when new interventions are tested (for example, latency-reversing agents, immune-based therapies, or gene-editing strategies), researchers need trustworthy measurement tools that can detect meaningful changes in the reservoir, compare results across studies, and avoid misleading signals caused by assay variability.

From an applicant and eligibility standpoint, this is a discretionary NIH grant mechanism under the STTR program using the R41/R42 award structure, which typically supports a phased development pathway from early proof-of-concept to more advanced research and development steps. The eligible applicants are small businesses (Small Business Concerns), consistent with STTR goals that couple small business commercialization efforts with research institution collaboration. Foreign (non-U.S.) entities are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible, although foreign components as defined in the NIH Grants Policy Statement may be allowed in some cases. The FOA states there is no cost sharing or matching requirement.

Administratively, the opportunity was posted on February 13, 2014, with an original and current closing date listed as January 7, 2017, and an archive date of February 7, 2017, meaning the solicitation is no longer open but remains relevant as a description of NIH priorities and the types of technologies NIH sought to stimulate through STTR funding. The funding activity category is health, and it is associated with CFDA numbers 93.286, 93.855, 93.856, and 93.859, reflecting NIH interests spanning technological innovation and infectious disease/microbiology research. For reference and full details, NIH provided the archived program announcement link at http://grants.nih.gov/grants/guide/pa-files/PA-14-102.html, and general access or technical issues were directed to the NIH Office of Extramural Research (OER) webmaster contact.

Frequently Asked Questions (FAQs)

What is the ITAS Cure (R41/R42) funding opportunity?

The Innovative Technologies and Assays in Support of HIV Cure Research (ITAS Cure) (R41/R42) is an NIH Small Business Technology Transfer (STTR) grant opportunity intended to drive development of practical, commercialization-ready tools that measure and characterize the persistent HIV reservoir in people living with HIV who are on effective antiretroviral therapy.

What is the Funding Opportunity Number (FOA) for this program?

The FOA is PA 14-102.

Which agency is offering this opportunity?

This opportunity is offered by the National Institutes of Health (NIH).

What problem is this FOA trying to solve?

The FOA targets the challenge that, even when standard clinical tests indicate viral suppression, small amounts of HIV can persist in cells and tissues. These persistent reservoirs are a major barrier to an HIV cure and are difficult to quantify reliably with existing methods.

What kinds of technologies is NIH trying to stimulate through this FOA?

NIH is encouraging next-generation technologies that can detect, measure, and track HIV reservoirs more accurately and consistently than currently available tools, with the goal of supporting real-world research use and eventual commercialization.

What types of deliverables are emphasized: assays, imaging, or both?

Both. The FOA highlights highly sensitive and quantitative assays, methods, and imaging techniques that can be applied directly to measuring residual HIV in treated individuals. It also emphasizes quantitative methods and analytical tools needed for reproducible assessment of viral burden.

Are only brand-new technologies eligible, or can existing platforms be adapted?

The announcement explicitly welcomes both entirely new technologies and novel applications of existing platforms, including the creation or innovative use of imaging agents or probes.

What specific HIV measurements is NIH particularly interested in improving?

NIH signals particular interest in tools that go beyond detecting HIV genetic material and instead can quantify replication-competent virus (virus that can reproduce and cause rebound) or measure integrated provirus (viral DNA inserted into the host genome).

Why does the FOA emphasize replication-competent virus and integrated provirus?

Because these measurements can provide more meaningful insight into the reservoir that drives rebound and persistence, compared with approaches that only detect HIV genetic material without clarifying whether the virus is capable of replication or integrated in a way relevant to persistence.

What does it mean to distinguish HIV-infected cells "in situ"?

In situ refers to identifying HIV-infected cells within their natural tissue context. The FOA emphasizes this capability as important for understanding where reservoirs persist and how they behave over time.

What performance improvements does NIH expect from proposed technologies?

The FOA states that proposed technologies should meaningfully outperform existing methods by offering one or more of the following: substantially improved sensitivity and quantitative reliability, better reproducibility across runs and across sites, improved spatiotemporal resolution (locating signals precisely in space and tracking changes over time), and/or better scalability for broader use.

What does "spatiotemporal resolution" mean in the context of this FOA?

It refers to the ability to precisely locate infected cells or relevant signals in space (where they are in tissues) and monitor how those signals change over time (the dynamics of persistence or response to interventions).

Why is reproducibility across runs and sites called out as a priority?

The FOA emphasizes reproducibility so that reservoir measurements are consistent and comparable, reducing the risk that observed changes are due to assay variability rather than real biological changes.

Does the FOA emphasize monitoring reservoir changes over time?

Yes. In addition to measurement sensitivity, the FOA highlights analytical approaches that can track viral burden related to replication-competent virus or integrated provirus over time, supporting monitoring of dynamic changes in persistent infection.

How does this FOA connect to testing HIV cure interventions?

The FOA notes a broader need in HIV cure research: when interventions are tested (such as latency-reversing agents, immune-based therapies, or gene-editing strategies), researchers need trustworthy tools that can detect meaningful changes in the reservoir and enable comparisons across studies.

What grant mechanism is used for this opportunity?

This is an NIH STTR opportunity using the R41/R42 award structure, which typically supports a phased development pathway from early proof-of-concept to more advanced research and development steps.

Who is eligible to apply?

Eligible applicants are small businesses (Small Business Concerns) under the STTR program, consistent with STTR goals that combine small business commercialization efforts with research institution collaboration.

Are foreign (non-U.S.) organizations eligible to apply?

No. The FOA states that foreign (non-U.S.) entities are not eligible to apply.

Are non-U.S. components of U.S. organizations eligible?

No. The FOA states that non-U.S. components of U.S. organizations are also not eligible.

Are any foreign components allowed at all?

The FOA indicates that foreign components, as defined in the NIH Grants Policy Statement, may be allowed in some cases.

Is cost sharing or matching required?

No. The FOA states there is no cost sharing or matching requirement.

When was this opportunity posted?

The opportunity was posted on February 13, 2014.

Is this FOA still open for applications?

No. The original and current closing date is listed as January 7, 2017, and the archive date is February 7, 2017, meaning the solicitation is no longer open.

If it is archived, why might the FOA still be useful?

Even though it is closed, it remains relevant as a description of NIH priorities and the types of technologies NIH sought to stimulate through STTR funding related to measuring and characterizing persistent HIV reservoirs.

What is the funding activity category?

The funding activity category is health.

Which CFDA numbers are associated with this opportunity?

The FOA is associated with CFDA numbers 93.286, 93.855, 93.856, and 93.859.

Where can applicants or researchers find the full archived announcement?

NIH provided the archived program announcement link at: http://grants.nih.gov/grants/guide/pa-files/PA-14-102.html

Who is listed for general access or technical issues with the announcement?

General access or technical issues were directed to the NIH Office of Extramural Research (OER) webmaster contact.

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