The Early Detection Research Network: Clinical Validation Centers (U01 Clinical Trial Optional) | RFA CA 22 054

Opportunity Information: Apply for RFA CA 22 054

The funding opportunity titled "The Early Detection Research Network: Clinical Validation Centers (U01 Clinical Trial Optional)" (RFA-CA-22-054) is a National Institutes of Health (NIH) cooperative agreement aimed at strengthening the Early Detection Research Network (EDRN), a long-running national program focused on improving how cancers are found at their earliest, most treatable stages. The EDRN’s core mission is to discover, develop, and clinically validate biomarkers and imaging approaches that can reliably detect early stage cancers and then move those discoveries toward real-world clinical tests. A major emphasis here is not just on finding promising markers, but on proving they work in practical, multi-site settings where variability in patients, samples, and clinical workflows can make or break a test. The EDRN is positioned as a mature infrastructure for this kind of work, and the announcement highlights that the network has already completed more than 10 multicenter validation studies, which signals that applicants are expected to plug into an established system with standardized processes and collaborative expectations.

This opportunity uses the U01 mechanism, which means it is a cooperative agreement rather than a standard research grant. In practice, that usually indicates substantial programmatic involvement from NIH staff and a higher level of coordination across awardees, with projects expected to align closely with network priorities, shared protocols, common resources, and collaborative governance. The "Clinical Trial Optional" designation indicates that proposed work may include clinical trials but does not require them, allowing applicants to propose a range of clinical validation activities, including prospective or retrospective validation studies, multi-center evaluations, and other clinically anchored efforts needed to move a biomarker or imaging method toward adoption. The activity category is listed under Education and Health, and the CFDA number associated with the program is 93.394.

Eligible applicants are broad and include many types of domestic organizations and government entities. Specifically, 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; public housing authorities and Indian housing authorities; Native American tribal organizations other than federally recognized tribal governments; nonprofit organizations with or without 501(c)(3) status (excluding institutions of higher education); for-profit organizations other than small businesses; and small businesses. The announcement also explicitly calls out additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions; Asian American, Native American, and Pacific Islander Serving Institutions (AANAPISIs); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); eligible federal agencies; faith-based or community-based organizations; regional organizations; U.S. territories or possessions; and Indian/Native American tribal governments other than federally recognized ones.

At the same time, the eligibility rules draw a clear line regarding foreign participation. Non-domestic (non-U.S.) entities and non-domestic foreign institutions are not eligible to apply as applicant organizations. Non-domestic components of U.S. organizations are also not eligible to apply. However, the announcement allows "foreign components" as defined by the NIH Grants Policy Statement, meaning an otherwise eligible U.S.-based applicant may include certain foreign activities or collaborations if they meet NIH’s definition and requirements for a foreign component. This distinction matters for teams that want to incorporate international specimens, study sites, or specialized capabilities, because it suggests collaboration may be possible but must be structured under NIH’s foreign component rules rather than through a foreign entity serving as the primary applicant.

Key administrative details provided include the sponsoring agency (NIH), the funding instrument type (cooperative agreement), the original closing date (2022-09-19), and the posting/creation date (2022-08-19). The award ceiling and expected number of awards are not specified in the provided source data, which typically means applicants would need to consult the full funding announcement text or NIH program contacts for budget expectations, project periods, and anticipated award counts. Overall, the opportunity is best understood as support for clinical validation centers that can operate within EDRN’s coordinated national framework to rigorously evaluate early cancer detection biomarkers and imaging methods, with the end goal of translating validated findings into clinically usable tests.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "The Early Detection Research Network: Clinical Validation Centers (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.
• This funding opportunity was created on 2022-08-19.
• Applicants must submit their applications by 2022-09-19. (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 22 054

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