Opportunity Information: Apply for PAR 24 097
Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional), Funding Opportunity Number PAR-24-097, is an NIH cooperative agreement designed to move promising neurological or neuromuscular biomarkers from the "strong candidate" stage into true clinical validation. The core aim is not discovery or early assay development, but rigorous testing of a biomarker in the real clinical population where it would be used, with study designs capable of producing reliable estimates of performance, especially positive predictive value (PPV) and negative predictive value (NPV). The opportunity explicitly frames validation in a way that aligns with FDA expectations for biomarker evidence, meaning applicants should be prepared to justify how their design, analysis plan, and patient selection will support clinically meaningful and regulator-relevant conclusions about how well the biomarker classifies or predicts the condition or outcome of interest.
This announcement assumes several key pieces are already in place before a project begins. First, the biomarker itself has already been identified as a strong candidate based on prior evidence. Second, the method for detecting or measuring the biomarker (the technology and assay) has already been developed and analytically validated, so the project is not meant to troubleshoot basic assay performance or invent a new measurement platform. Third, the clinical or research need is already articulated, along with the biomarker's potential context of use, such as diagnosis, prognosis, patient stratification, disease monitoring, pharmacodynamic response, or another defined role. In other words, this PAR is meant to fund the expensive, careful stage where you prove that the biomarker measurement holds up in the intended patient population and setting, producing clinically interpretable predictive values rather than just statistical associations.
The mechanism is a U01 cooperative agreement, which generally indicates substantial NIH programmatic involvement compared with a standard investigator-initiated grant. Practically, that often means awardees should expect active coordination with NIH staff on milestones, study conduct, data quality expectations, and possibly harmonization with broader NIH biomarker efforts. The "Clinical Trial Optional" label means applicants may propose a clinical trial if it is appropriate for validation, but they are not required to do so; strong observational or prospective cohort designs may also be suitable, depending on the biomarker's intended use and what evidence is needed to establish performance.
Eligibility is broad across government, academic, nonprofit, and industry organizations. Eligible applicants include state, county, city, township, and 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 that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses. The announcement also calls out additional eligible applicant types, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, faith-based or community-based organizations, Hispanic-serving institutions, HBCUs, tribally controlled colleges and universities, regional organizations, eligible federal agencies, and U.S. territories or possessions. At the same time, it draws clear lines around foreign involvement: non-domestic (non-U.S.) entities are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components as defined by the NIH Grants Policy Statement are allowed, meaning certain international collaborations may be permissible when they meet NIH definitions and are justified within the project.
The opportunity is categorized as discretionary funding under the health activity area and is associated with CFDA number 93.853. The agency is the National Institutes of Health. It was created on 2024-01-22 and is described as a reissue of PAR-21-058, signaling continuity with an earlier program but updated as PAR-24-097. The listed original closing date is 2026-06-22. While an award ceiling is not specified in the provided source text and the number of expected awards is not shown, applicants should treat this as a competitive, milestone-driven biomarker validation program where budgets, timelines, and enrollment plans will likely be scrutinized for feasibility and for the ability to deliver definitive clinical validation evidence.
Overall, this PAR is best suited for teams that already have a well-supported biomarker candidate and a validated assay, and who are ready to run a carefully designed clinical validation study that can credibly establish predictive values in the target patient population. The emphasis is on rigor, real-world clinical relevance, and producing results that can support a clear context of use consistent with FDA-oriented biomarker evidentiary standards.Apply for PAR 24 097
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (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 2024-01-22.
- Applicants must submit their applications by 2026-06-22. (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.
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FAQs: Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional) - PAR-24-097
What is the PAR-24-097 funding opportunity?
PAR-24-097 is an NIH cooperative agreement (U01) that supports the clinical validation of a promising (already identified) biomarker for neurological or neuromuscular disorders. The goal is to move a biomarker from the "strong candidate" stage into true clinical validation in the real clinical population where it would be used.
What is the main goal of this program?
The core aim is rigorous clinical validation that can produce reliable, clinically interpretable performance estimates, especially positive predictive value (PPV) and negative predictive value (NPV), in the intended-use patient population and setting.
Is this funding meant for biomarker discovery?
No. This opportunity is not focused on biomarker discovery. It is intended for biomarkers that are already strong candidates based on prior evidence.
Is this funding meant for early assay development or troubleshooting?
No. The announcement assumes the measurement method (technology and assay) has already been developed and analytically validated. The project is not meant to invent a new platform or troubleshoot basic assay performance.
What kinds of biomarkers or conditions are in scope?
The scope is biomarkers relevant to neurological or neuromuscular disorders, with the emphasis on validating performance in the clinical population where the biomarker would be used.
What does "clinical validation" mean in this announcement?
Clinical validation here means testing the biomarker in the intended clinical population and setting using rigorous study designs that can yield reliable estimates of how well the biomarker classifies or predicts the condition or outcome of interest, including PPV and NPV.
Why does the opportunity emphasize PPV and NPV?
The program emphasizes PPV and NPV because they are clinically meaningful measures of how well a biomarker performs in the real population where it would be applied, beyond simply showing statistical associations.
How does this opportunity relate to FDA expectations?
The announcement frames validation in a way that aligns with FDA-oriented expectations for biomarker evidence. Applicants should be prepared to justify how their study design, analysis plan, and patient selection support regulator-relevant conclusions about biomarker performance and clinical meaning.
What is meant by "context of use" for the biomarker?
The program expects applicants to have a defined biomarker context of use, such as diagnosis, prognosis, patient stratification, disease monitoring, pharmacodynamic response, or another clearly specified role.
Do applicants need to already have clinical or research need articulated?
Yes. The announcement assumes the clinical or research need is already articulated along with the biomarker's potential context of use.
What does "U01 cooperative agreement" mean for applicants?
A U01 cooperative agreement generally indicates substantial NIH programmatic involvement compared with standard investigator-initiated grants. Awardees should expect active coordination with NIH staff, potentially including milestones, study conduct expectations, data quality expectations, and possible harmonization with broader NIH biomarker efforts.
Is a clinical trial required?
No. The opportunity is labeled "Clinical Trial Optional," meaning applicants may propose a clinical trial if it is appropriate for validation, but they are not required to do so.
If a clinical trial is not required, what other study designs might fit?
The announcement indicates that strong observational or prospective cohort designs may be suitable, depending on the biomarker's intended use and the evidence needed to establish performance.
What stage should the biomarker and assay be at before applying?
The biomarker should already be identified as a strong candidate, and the detection/measurement method should already be developed and analytically validated. The funded work is intended to be the expensive and careful clinical validation stage.
What types of organizations are eligible to apply?
Eligibility is broad and includes government, academic, nonprofit, and industry organizations. Eligible applicants include state, county, city, township, 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; non-federally recognized tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses.
Are there additional eligible organization types explicitly mentioned?
Yes. The announcement also calls out Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, faith-based or community-based organizations, Hispanic-serving institutions, HBCUs, tribally controlled colleges and universities, regional organizations, eligible federal agencies, and U.S. territories or possessions.
Can non-U.S. (foreign) organizations apply?
No. Non-domestic (non-U.S.) entities are not eligible to apply.
Can a U.S. organization apply if it has a non-domestic component?
No. Non-domestic components of U.S. organizations are not eligible to apply.
Are any international collaborations allowed at all?
Yes. Foreign components, as defined by the NIH Grants Policy Statement, are allowed. This means certain international collaborations may be permissible when they meet NIH definitions and are justified within the project.
Which agency is offering this opportunity?
The agency is the National Institutes of Health (NIH).
What is the Funding Opportunity Number?
The Funding Opportunity Number is PAR-24-097.
What is the activity area and funding type noted?
The opportunity is categorized as discretionary funding under the health activity area.
What CFDA number is associated with this opportunity?
The associated CFDA number is 93.853.
When was this opportunity created?
The opportunity was created on 2024-01-22.
Is PAR-24-097 related to an earlier NIH program?
Yes. It is described as a reissue of PAR-21-058, indicating continuity with an earlier program that has been updated as PAR-24-097.
What is the original closing date listed for this opportunity?
The listed original closing date is 2026-06-22.
Is there an award ceiling or number of expected awards provided?
Not in the provided information. The award ceiling is not specified, and the number of expected awards is not shown in the source text provided.
What should applicants expect NIH reviewers to scrutinize?
Based on the program framing, applicants should expect close scrutiny of feasibility and rigor, including budgets, timelines, enrollment plans, and whether the design and analysis plan can deliver definitive, clinically meaningful validation evidence (including PPV/NPV) in the intended-use population.
Who is this program best suited for?
This program is best suited for teams that already have a well-supported biomarker candidate and a validated assay and are ready to run a carefully designed clinical validation study that can credibly establish predictive performance in the target patient population, with real-world clinical relevance and FDA-aligned evidentiary framing.
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