Innovative Technologies to Non-Invasively Monitor Genome Edited Cells In Vivo (UH2/UH3 Clinical Trial Not Allowed) | RFA RM 18 025

Opportunity Information: Apply for RFA RM 18 025

This National Institutes of Health (NIH) funding opportunity, titled "Innovative Technologies to Non-Invasively Monitor Genome Edited Cells In Vivo (UH2/UH3 Clinical Trial Not Allowed)," is focused on pushing forward new ways to track genome-edited cells inside a living organism without relying on invasive sampling. The central idea is straightforward but technically demanding: if researchers can reliably label edited cells and then monitor them over time using non-invasive readouts, it becomes much easier to evaluate whether in vivo genome editing is working as intended, how long edited cells persist, where they go in the body, and whether any safety concerns emerge later. The technologies supported under this announcement are meant to generate information that speaks directly to both safety and efficacy as genome editing moves closer to broader clinical translation, while explicitly excluding clinical trials under this specific mechanism.

The award uses the UH2/UH3 phased cooperative agreement structure, which is commonly designed for high-impact, milestone-driven technology development efforts. In practice, this kind of structure generally supports an initial phase aimed at establishing feasibility and building or refining the core technology (UH2), followed by a second phase that emphasizes more advanced development, validation, and demonstration of performance (UH3), typically triggered by meeting predefined milestones. Because it is a cooperative agreement rather than a standard grant, NIH involvement is usually more hands-on than with traditional investigator-initiated mechanisms, with a stronger emphasis on ongoing coordination, agreed-upon benchmarks, and active programmatic oversight to keep the project aligned with the FOA goals.

Scientifically, the opportunity targets the gap between making an edit and actually understanding what happens afterward in a complex living system. Genome editing performed in vivo can produce a mix of outcomes across cell types and tissues, and some of the most important questions are time-dependent: whether edited cells expand or diminish, whether edits remain stable, whether off-target or unintended biological effects show up later, and whether edited cells end up in unexpected anatomical sites. Non-invasive monitoring technologies can help answer these questions more efficiently and repeatedly, reducing reliance on serial biopsies or terminal tissue collection and enabling more realistic longitudinal tracking. The technologies envisioned would ideally support repeated measurements over time and potentially be adaptable across different editing platforms and delivery approaches, though the FOA summary provided emphasizes the monitoring and labeling challenge rather than a particular editing system.

Eligibility for this opportunity is broad and includes a wide range of U.S.-based and certain non-U.S. entities. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized governments; public housing authorities and Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (as long as they are not institutions of higher education when applying in that category); for-profit organizations other than small businesses; small businesses; and other organizations. The announcement also highlights additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and foreign (non-U.S.) entities. This breadth signals NIH interest in drawing ideas from many sectors, including academic labs, industry technology developers, community-linked organizations, and specialized institutions that can contribute unique capabilities or patient-relevant perspectives.

Administratively, the opportunity is listed as a discretionary funding program with a cooperative agreement funding instrument and falls under the health activity category. It is associated with CFDA number 93.310 and is identified by Funding Opportunity Number RFA-RM-18-025. The original closing date was October 18, 2018, and the posting (creation) date is July 25, 2018, which places it in a specific historical NIH funding cycle for that year. The source data lists an award ceiling of $150,000, which suggests either a capped budget component, a specific phase limitation, or a particular cost constraint in the published record; applicants typically would need to confirm in the full FOA details how that ceiling applies (for example, per year, per phase, or per budget period) and what costs are allowable within the cooperative agreement framework.

A key boundary condition is stated directly in the title: "Clinical Trial Not Allowed." That means projects should not propose clinical trial activities under this FOA, even if the ultimate long-term goal is to support future clinical translation. Instead, the work is expected to stay in the technology development and preclinical demonstration space, focusing on tools and methods that can later enable safer and more informative clinical development. In summary, the NIH is using this opportunity to accelerate the creation of practical, reliable, and repeatable non-invasive approaches for labeling and tracking genome-edited cells in living systems, with the intent that these tools will make it easier to judge safety and effectiveness over time for in vivo genome editing strategies.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Innovative Technologies to Non-Invasively Monitor Genome Edited Cells In Vivo (UH2/UH3 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.310.
• This funding opportunity was created on 2018-07-25.
• Applicants must submit their applications by 2018-10-18. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $150,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA RM 18 025

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