The Early Detection Research Network: Biomarker Characterization Centers (U2C Clinical Trial Not Allowed) | RFA CA 22 040

Opportunity Information: Apply for RFA CA 22 040

The funding opportunity titled "The Early Detection Research Network: Biomarker Characterization Centers (U2C Clinical Trial Not Allowed)" (RFA-CA-22-040) is a National Institutes of Health (NIH) cooperative agreement designed to support a key set of research hubs within the Early Detection Research Network (EDRN). EDRN functions as a national, coordinated infrastructure focused on improving early cancer detection and cancer risk assessment by advancing biomarkers and imaging approaches. In practical terms, this FOA is aimed at building and sustaining specialized centers that can move promising biomarker ideas from early discovery and assay development toward readiness for larger-scale validation work across the Network.

The specific centers being solicited are Biomarker Characterization Centers (BCCs), which represent one of the three main scientific units that make up the continuing EDRN program. The BCC role is centered on the scientific and technical work needed to get biomarkers into a form that can be credibly tested and validated in broader clinical contexts. These centers are expected to discover new biomarkers, further develop and characterize them, and test their performance in well-controlled research settings. They may also refine existing biomarkers that show promise but need more work to improve sensitivity, specificity, robustness, or overall usability. A major emphasis is placed on assay-related capabilities: BCCs are expected to develop, refine, and/or standardize biomarker assays so results are reliable and comparable across laboratories and studies. Beyond their own biomarker pipeline work, BCCs are also expected to provide tangible resources and support that enable validation of EDRN-developed biomarkers, and to participate actively in collaborative projects with other EDRN laboratories and centers, rather than operating as isolated, single-lab efforts.

BCCs are positioned within a broader EDRN ecosystem that is designed to cover the full arc from biomarker development to validation at scale. The second scientific unit is the Clinical Validation Centers (CVCs). CVCs lead the clinical research needed to validate biomarkers and also serve as resource centers for the Network by working jointly with BCCs and the Data Management and Coordinating Center (DMCC) on collaborative validation studies. The third unit, the DMCC, provides the backbone for statistical and computational analysis, data and informatics infrastructure, and study design support. The DMCC also handles coordination and management of EDRN-sponsored biomarker validation studies and organizes Network-wide meetings and workshops, which is important because EDRN is structured around coordinated, multi-site collaboration and shared standards.

This FOA uses the U2C cooperative agreement mechanism, which generally means funded centers should expect substantial NIH programmatic involvement compared with a standard research grant. The title also makes clear that clinical trials are not allowed under this announcement, signaling that the supported work should focus on biomarker discovery, characterization, assay development, and related preparatory or enabling research activities rather than interventional clinical trial conduct.

In terms of eligibility, the opportunity is broadly open to a wide range of U.S.-based organizations and government entities, reflecting the infrastructure-building nature of EDRN. 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 (including those other than federally recognized tribal governments); public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (as long as they are not institutions of higher education when applying under those nonprofit categories); for-profit organizations (other than small businesses); and small businesses. The FOA also explicitly highlights additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), 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, and U.S. territories or possessions. At the same time, it draws clear boundaries around foreign participation: non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply as the applicant organization. However, "foreign components" as defined by the NIH Grants Policy Statement are allowed, meaning a U.S. applicant may include certain defined international elements within the project when justified and compliant with NIH policy.

Key administrative details from the source data include the sponsoring agency (NIH), the opportunity category (discretionary), the funding instrument type (cooperative agreement), the activity area (education and health), and the CFDA number 93.394. The FOA was created on July 18, 2022, and the original closing date listed is September 8, 2022. The provided record does not specify an award ceiling or expected number of awards in the excerpt, so applicants would typically need to consult the full FOA text for budget limits, project period expectations, and other application requirements.

Overall, the central idea of this grant opportunity is to fund centers that can do the heavy-lift scientific and technical work of turning candidate cancer biomarkers into rigorously characterized, well-assayed tools that are ready for network-supported validation efforts. Success in this program is inherently collaborative: BCCs are expected to contribute not only through their own biomarker and assay development outputs, but also by supporting EDRN-wide validation activities and working in close coordination with CVCs and the DMCC to ensure methods, data, and results can be compared and integrated across the Network.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "The Early Detection Research Network: Biomarker Characterization Centers (U2C 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): 93.394.
• This funding opportunity was created on 2022-07-18.
• Applicants must submit their applications by 2022-09-08. (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 22 040

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