Analytical and Clinical Validation of Biomarkers for Alzheimers Disease (AD) and AD-Related Dementias (ADRD)?(U01 Clinical Trial Optional) | PAR 23 258

Opportunity Information: Apply for PAR 23 258

The NIH funding opportunity titled "Analytical and Clinical Validation of Biomarkers for Alzheimers Disease (AD) and AD-Related Dementias (ADRD) (U01 Clinical Trial Optional)" (Funding Opportunity Number PAR-23-258) is a discretionary health-related grant program that uses the cooperative agreement mechanism (U01). Its central purpose is to speed up the development of biomarkers that are truly dependable in real-world research and care settings for Alzheimers disease and related dementias. In practical terms, the program is designed to move biomarkers beyond early discovery and into the more demanding phases of analytical validation and/or clinical validation, so they can be used with confidence in therapy and medical product development, clinical trials, and potentially routine clinical practice.

A key feature of this NOFO is its emphasis on rigor that aligns with what the FDA expects for regulatory-grade biomarker work. The solicitation specifically points applicants toward standards comparable to those in the FDA Biomarker Qualification Program (BQP) and other FDA regulatory pathways. That framing matters because it signals that proposed studies should not be exploratory or loosely defined. Instead, projects are expected to use well-justified methods, clearly specified performance characteristics, and carefully planned validation strategies that would stand up to scrutiny if the biomarker were later used to support drug development decisions, trial enrollment or stratification, outcome measurement, or other high-stakes contexts.

The scope includes support for validating a single biomarker, a composite biomarker, or a broader biomarker signature. This means the opportunity is not limited to one test or one modality; it can fit a range of approaches so long as the work is geared toward demonstrating reliability and usefulness for a defined purpose. "Analytical validation" typically focuses on how well a test measures what it claims to measure from a technical standpoint, including issues like accuracy, precision, sensitivity, specificity, reproducibility, and robustness across sites, operators, instruments, and conditions. "Clinical validation" generally centers on how well the biomarker relates to a clinical state or outcome in AD/ADRD, such as diagnosis, prognosis, disease staging, progression, or response prediction, again with a level of evidence that supports downstream decision-making in trials or care. The NOFO allows either or both forms of validation, as long as the validation plan is substantial and appropriately matched to the intended use.

Because the award mechanism is a cooperative agreement, applicants should expect meaningful involvement from NIH program staff during the project period compared with a standard research project grant. Cooperative agreements often imply a more collaborative relationship, with shared expectations around milestones, data quality, harmonization practices, and project governance. The listing also notes that clinical trials are optional, which leaves room for both trial-based validation efforts and rigorous non-trial study designs, depending on what best fits the biomarker and the intended context of use.

Eligibility is broad and includes many types of organizations that might contribute to biomarker validation work. Eligible applicants include various levels of government (state, county, city or township, and special districts), independent school districts, public housing authorities/Indian housing authorities, and tribal governments (federally recognized) as well as tribal organizations that are not federally recognized governments. Academic institutions are eligible across public and state-controlled institutions of higher education and private institutions of higher education. The NOFO also welcomes nonprofit organizations (both 501(c)(3) and non-501(c)(3), other than institutions of higher education), for-profit organizations (other than small businesses), and small businesses. In addition, it explicitly calls out other eligible applicant categories 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, non-domestic (non-U.S.) entities (foreign organizations), and U.S. territories or possessions. Taken together, this reflects an intent to draw on a wide range of scientific, clinical, and community-linked capabilities, which can be important for assembling diverse cohorts and ensuring that validated biomarkers perform well across populations and settings.

Administratively, the opportunity is run by the National Institutes of Health and is associated with CFDA number 93.866. The original closing date listed is March 5, 2026. Some fields such as the award ceiling and expected number of awards are not specified in the provided source data, so applicants typically need to consult the full funding announcement and related NIH guidance for budget expectations, project periods, and any institute- or center-specific priorities tied to this NOFO.

Overall, the program is aimed at closing a common gap in AD/ADRD research: many candidate biomarkers show promise in discovery studies, but far fewer are validated to a standard that makes them dependable tools for therapeutic development, multicenter clinical trials, and clinical decision-making. This NOFO targets that gap directly by funding projects that can produce well-characterized, reproducible biomarkers or biomarker signatures with validation evidence strong enough to align with FDA-oriented expectations for use in medical product development and, potentially, eventual clinical adoption.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Analytical and Clinical Validation of Biomarkers for Alzheimers Disease (AD) and AD-Related Dementias (ADRD)?(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): 93.866.
• This funding opportunity was created on 2023-08-16.
• Applicants must submit their applications by 2026-03-05. (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 PAR 23 258

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