Analytical Validation of Candidate Biomarkers for Neurological Disease (U01 Clinical Trial Optional) | PAR 18 550

Opportunity Information: Apply for PAR 18 550

The grant opportunity titled "Analytical Validation of Candidate Biomarkers for Neurological Disease (U01 Clinical Trial Optional)" (Funding Opportunity Number PAR-18-550) is a discretionary National Institutes of Health (NIH) program that uses the cooperative agreement mechanism (U01). Its core aim is to fund projects that carry out rigorous analytical validation of candidate biomarkers, biomarker-based measures, or biomarker-derived endpoints relevant to neurological diseases. The emphasis is on validating how well a biomarker test or measurement performs from an analytical standpoint, meaning the work should demonstrate that the assay or measurement method is reliable, accurate, precise, and otherwise fit-for-purpose for its specific intended use. The opportunity explicitly frames this work as needing to be consistent with U.S. Food and Drug Administration (FDA) guidelines and expectations, reflecting a focus on standards that support downstream regulatory-grade decision making.

In practical terms, the FOA is centered on analytical validation rather than discovery. That means applicants are expected to start with a "candidate" biomarker that already has a scientific rationale and preliminary evidence supporting its relevance, and then build the kind of data package that shows the measurement itself behaves predictably and robustly. Analytical validation typically involves characterizing performance attributes such as accuracy/trueness, precision (repeatability and reproducibility), sensitivity, specificity, limits of detection and quantitation where applicable, linearity and dynamic range, stability, robustness to pre-analytical variables (like collection, processing, storage, and shipping conditions), interference, lot-to-lot consistency, operator/instrument variability, and performance across sites if the assay is meant to be used broadly. The overall goal is to show that the biomarker measurement can be trusted for its intended context, whether that is patient stratification, pharmacodynamic monitoring, disease progression tracking, or another defined use case. The "Clinical Trial Optional" label indicates that a clinical trial is not required but may be included if it is appropriate for supporting the analytical validation plan.

The funding instrument is a cooperative agreement, which typically means NIH expects substantial programmatic involvement during the project compared with a standard research grant. While the specific details of that involvement are not listed in the provided text, cooperative agreements commonly include coordinated milestones, active communication with NIH program staff, and potentially harmonization with broader NIH efforts in biomarker development. The activity category is health, and the CFDA number is 93.853, which corresponds to NIH-supported health research activities in this area.

Eligibility is broad and includes many standard applicant types: 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/Indian housing authorities; tribal organizations that are not federally recognized; nonprofits with and without 501(c)(3) status (excluding institutions of higher education in those categories); for-profit organizations other than small businesses; and small businesses. The FOA also highlights additional eligible applicant categories, underscoring inclusivity across institution types and geographies. These include 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, U.S. territories or possessions, tribal governments that are not federally recognized, and non-U.S. entities (foreign organizations). This breadth suggests the program is open to a wide range of groups capable of conducting high-quality analytical validation work, including entities that can contribute specialized laboratory methods, clinical sample resources, or multi-site coordination.

The opportunity was created on 2017-12-22, and the original closing date listed is 2020-09-07. The source text does not provide an award ceiling or the expected number of awards, so applicants would typically need to consult the full FOA documentation for budget caps, project period limits, and any guidance on anticipated award sizes and counts. Overall, the opportunity is designed for teams that are ready to move beyond biomarker identification and into the demanding, standards-driven phase of proving that a biomarker assay or endpoint can perform consistently and credibly for neurological disease research and, potentially, future clinical or regulatory applications.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Analytical Validation of Candidate Biomarkers for Neurological Disease (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): 93.853.
• This funding opportunity was created on 2017-12-22.
• Applicants must submit their applications by 2020-09-07. (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 18 550

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