Cancer Prevention, Detection, Diagnosis, and Treatment Technologies for Global Health (U01 Clinical Trial Optional) | RFA CA 21 030

Opportunity Information: Apply for RFA CA 21 030

The National Institutes of Health (NIH), through the National Cancer Institute (NCI), issued this Funding Opportunity Announcement (FOA) to push forward practical cancer technologies that can actually work in low- and middle-income countries (LMICs). The central idea is not to fund early, purely conceptual research, but to help teams take an existing or emerging technology that already has a working prototype (an assay or device) and reshape it into something that is affordable, robust, and easy to use in real-world LMIC health care settings. The opportunity sits within NCI's broader Affordable Cancer Technologies (ACTs) Program, which focuses on bringing down cost and complexity while improving access to cancer prevention, detection, diagnosis, and treatment tools.

This specific announcement is for a U01 cooperative agreement, meaning the project is expected to be highly goal-driven and milestone-based, with substantial coordination and involvement typical of cooperative agreements. Clinical trials are optional under this FOA, so applicants can propose either preclinical-to-clinical validation work or clinical performance studies if appropriate. The work supported is meant to cover the full development arc needed to get an LMIC-ready tool closer to deployment: adapting the technology for cancer use (or for a specific cancer application), proving it functions technically as intended, and then demonstrating clinical performance in the intended LMIC environment. A key expectation is that teams will define objective performance milestones, meet them in stages, and then iterate with improvements and additional validation in-country, rather than stopping at a one-time lab demonstration.

The FOA is intentionally broad about the kinds of technologies it will consider, as long as they clearly address cancer prevention, detection, diagnosis, and/or treatment in LMIC contexts. Projects might involve point-of-care diagnostics, screening tools, imaging or sample-processing approaches, pathology-enabling technologies, triage tests, treatment delivery aids, or other platforms that can be adapted for oncology use. What matters is fit-for-purpose design: the technology needs to be tailored to constraints that often define LMIC settings, such as limited infrastructure, intermittent electricity, supply chain challenges, fewer specialized staff, and the need for simple workflows. Reviewers are looking for designs that are user-friendly at the point-of-need, not tools that only work in ideal laboratory environments.

A major theme is affordability and cost-effectiveness, treated not as an afterthought but as part of the design requirements from the start. Applicants are expected to factor in how much the tool will cost to produce and operate, what maintenance and consumables look like, whether it can be used with minimal training, and how it fits into actual care pathways. Usability in the field, durability, ease of interpretation, and realistic implementation plans are all implicit priorities, because the end goal is not just a working device but one that can be adopted and sustained in the target health systems.

Because successful LMIC cancer technology development is rarely a single-discipline job, the FOA requires truly multidisciplinary teams. At minimum, applicant groups must include expertise in engineering or assay/treatment development, oncology, global health care delivery (so the tool matches the reality of clinics and communities), and business development (to address manufacturing, pricing, distribution, regulatory pathways, and long-term sustainability). The inclusion of business development is a clear signal that NCI wants technologies that can move beyond the prototype stage toward scalable production and real uptake, rather than remaining stuck in a research-only pipeline.

In terms of eligibility, the opportunity is open to a wide range of applicants across government, academia, nonprofit, and industry. Eligible applicants include state, county, city or township 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; other Native American tribal organizations; public housing and Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses. The FOA also highlights additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, and non-U.S. (foreign) organizations and regional organizations, reflecting a strong interest in inclusive participation and global collaboration.

Administratively, this is a discretionary funding opportunity using the cooperative agreement mechanism (U01). The opportunity number is RFA-CA-21-030, and it falls under NIH/NCI with CFDA listings 93.394 and 93.395. The original closing date listed is 2021-06-02, and the FOA record creation date is 2021-02-19. While the excerpt does not provide an award ceiling or expected number of awards, the emphasis on milestone-driven development, LMIC validation, and multidisciplinary teaming makes clear that projects are expected to be well-scoped, execution-focused, and ready to move a prototype toward credible clinical performance evidence in the settings where it is most needed.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Cancer Prevention, Detection, Diagnosis, and Treatment Technologies for Global Health (U01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.394, 93.395.
• This funding opportunity was created on 2021-02-19.
• Applicants must submit their applications by 2021-06-02. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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 CA 21 030

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