Analytical and Clinical Validation of Biomarkers for Alzheimers Disease (AD) and AD-Related Dementias (ADRD) (U01 Clinical Trial Optional) | PAR 25 209

Opportunity Information: Apply for PAR 25 209

The National Institutes of Health (NIH) is offering a cooperative agreement opportunity (U01; Clinical Trial Optional) titled "Analytical and Clinical Validation of Biomarkers for Alzheimers Disease (AD) and AD-Related Dementias (ADRD)." The central aim is to speed up the development of biomarkers that are dependable enough to be used confidently in real-world settings, including therapeutic and medical product discovery and development, the design and execution of clinical trials, and potentially routine clinical practice. The emphasis is not on early discovery of new candidate markers, but on doing the careful, systematic work needed to prove that a biomarker (or a composite/signed set of biomarkers) performs reliably and meaningfully for a defined purpose.

This NOFO specifically supports projects focused on analytical validation and/or clinical validation. In practical terms, analytical validation is about showing that the biomarker measurement itself is accurate, precise, reproducible, and robust across conditions that matter (such as different operators, sites, instruments, lots, runs, and sample handling conditions). Clinical validation is about demonstrating that the biomarker readout is clinically meaningful for a stated context of use, such as identifying or enriching for a particular AD/ADRD population, tracking disease progression, predicting risk, or supporting clinical trial endpoints. Importantly, the validation rigor is expected to be comparable to what the FDA expects under its Biomarker Qualification Program (BQP) or other relevant FDA regulatory pathways. That language signals a high bar for study design, documentation, statistical rigor, standardization, and evidence quality, with the end goal of generating results that can stand up to regulatory scrutiny and be broadly trusted by researchers, developers, and clinicians.

The funding mechanism is a cooperative agreement, which typically means NIH staff will have substantial programmatic involvement compared with a standard grant. Applicants should anticipate an active partnership structure, where NIH may help guide key aspects like milestones, coordination, and alignment with broader program goals. The listing is categorized as discretionary funding in the health area, associated with CFDA number 93.866. The opportunity number is PAR 25 209, and the original application due date provided is March 5, 2026 (with the opportunity created on November 14, 2024). The notice does not provide an award ceiling or expected number of awards in the excerpted source data, so applicants would need to consult the full announcement for budget limits, project period expectations, and review considerations.

Eligibility is broad and includes many types of domestic applicants: state, county, and local governments; special districts; 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; public housing authorities/Indian housing authorities; nonprofits (both 501(c)(3) and non-501(c)(3), excluding institutions of higher education in those nonprofit categories); for-profit organizations other than small businesses; and small businesses. In addition, the NOFO explicitly highlights a wide range of other eligible applicant categories, including 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 non-U.S. entities (foreign organizations). This broad eligibility suggests NIH is encouraging wide participation, potentially including groups positioned to recruit diverse cohorts or contribute specialized technical capabilities for biomarker validation.

In short, this opportunity is designed for teams that already have a promising AD/ADRD biomarker approach and are ready to do the hard validation work needed to make it reliable, standardized, and fit for a clearly defined purpose. Projects that align best are those that can lay out a credible path to analytically sound measurement and clinically meaningful performance, supported by rigorous evidence generation that maps onto FDA-level expectations for biomarker qualification or related regulatory pathways.

• 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 2024-11-14.
• 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 25 209

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