Opportunity Information: Apply for PAR 23 088
The National Institutes of Health (NIH), through the National Cancer Institute (NCI), is offering the grant opportunity "Revision Applications for Validation of Biomarker Assays Developed Through NIH-Supported Research Grants (R01 Clinical Trial Not Allowed)" (Funding Opportunity Number PAR-23-088). The main goal is to speed up the movement of promising, NCI-supported assay methods and technologies from the research setting into practical clinical use. Rather than funding brand-new assay inventions, this program is meant to help investigators take assays that were already developed with NIH support and push them through the next critical phase: adapting them for clinical settings and clinically validating them so they are truly ready to be used as investigational tools in future clinical trials.
The scientific focus is on biomarkers for cancer across multiple use cases. Supported projects can center on molecular, cellular, or imaging markers that help with cancer detection and diagnosis, prognosis and disease monitoring, and predicting response to treatment. The scope also includes biomarkers relevant to cancer control and prevention, not only treatment decision-making. In other words, the FOA targets assays that can inform real clinical questions, such as whether cancer is present, how aggressive it may be, whether it is responding to therapy, and how risk or prevention strategies might be guided.
A key feature of the opportunity is the emphasis on clinical validation using high-quality, well-annotated human specimens and data. Applicants may propose to obtain specimens from NCI-supported clinical trials as well as from other clinical trials, observational cohorts, or larger consortia, as long as the materials are well characterized and appropriate for rigorous validation. This highlights that the FOA is focused on evidence generation: showing that the assay performs reliably and meaningfully in clinically relevant populations and settings, not just in controlled laboratory experiments.
The FOA strongly encourages team science and multidisciplinary project design. Competitive applications are expected to bring together assay developers with clinicians who understand the clinical context, clinical laboratory staff who can address real-world implementation details, and statisticians who can design robust validation plans and analyses. In particular, clinical laboratory scientists and statistical experts are described as important, integrated members of the research team, reflecting how much emphasis is placed on analytical rigor, reproducibility, and clinically credible performance metrics.
It is also clearly stated what the FOA is not intended to support. This is not a mechanism for early-stage technology development, basic proof-of-concept work, or exploratory biomarker discovery. It also does not support conducting clinical trials, consistent with the "Clinical Trial Not Allowed" designation. Instead, it fills the gap between initial assay development and readiness for use in clinical trials, aiming to position validated assays so they can be incorporated into trials later as investigational assays, tools, or devices.
From an administrative standpoint, this is a discretionary NIH grant in the education and health funding activity area and is tied to CFDA number 93.394. The listed award ceiling is $150,000, and the original closing date provided in the source information is 2023-10-27. Eligibility is broad and includes many types of domestic U.S. organizations and government entities, such as state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; and public housing authorities/Indian housing authorities. It also includes federally recognized tribal governments and other tribal organizations, nonprofits (with or without 501(c)(3) status), for-profit organizations (other than small businesses), and small businesses. In addition, the FOA explicitly calls out categories of other eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, regional organizations, eligible federal agencies, U.S. territories or possessions, and even non-U.S. entities (foreign organizations).
Overall, this opportunity is designed for investigators who already have a biomarker assay supported by prior NIH-funded research and now need targeted resources to adapt it to clinical workflows and generate strong validation evidence using well-annotated specimens and sound statistical methods. The intended endpoint is a clinically credible, well-characterized assay that is ready to be deployed in subsequent clinical trial settings as an investigational measurement tool, helping shorten the timeline between biomarker innovation and real patient impact.Apply for PAR 23 088
- The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Revision Applications for Validation of Biomarker Assays Developed Through NIH-Supported Research Grants (R01 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 2023-01-06.
- Applicants must submit their applications by 2023-10-27. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $150,000.00 in funding.
- 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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