Revision Applications for Validation of Biomarker Assays Developed Through NIH-Supported Research Grants (R01 Clinical Trial Not Allowed) | PAR 20 074

Opportunity Information: Apply for PAR 20 074

This funding opportunity, PAR-20-074, is a National Institutes of Health grant announcement that supports revision applications (not brand-new, stand-alone projects) aimed at moving cancer-related biomarker assays closer to real clinical use. The central goal is to speed up translation of assays, methods, or technologies that were originally developed with support from the National Cancer Institute (NCI) or other NIH-supported research grants, and to take the next practical step: adapting those assays for clinical settings and validating them using real-world, clinically relevant samples and data. The announcement is structured as an R01 mechanism and explicitly does not allow clinical trials under this FOA, meaning the work should be focused on assay adaptation and validation rather than testing patient outcomes through an interventional study.

The scientific scope is centered on biomarkers across several major cancer use-cases. Projects may focus on molecular, cellular, or imaging biomarkers for cancer detection and diagnosis, prognosis, disease monitoring, and prediction of treatment response. It also includes biomarkers relevant to cancer prevention and cancer control. The emphasis is not on inventing a new platform from scratch, but on taking an assay that already exists from prior NIH-supported work and doing the careful, rigorous steps needed for clinical validation. In practical terms, that can include improving how the assay runs in a clinical laboratory workflow, establishing performance characteristics, verifying reproducibility and robustness, and generating evidence that the biomarker readout is clinically meaningful for its intended context of use.

A key feature of this FOA is the expectation that applicants will validate assays using well-annotated clinical specimens, often drawn from existing resources such as NCI-supported clinical trials, observational cohorts, or consortia. The announcement allows and encourages applications to request support for acquiring these specimens when they are needed to complete clinical validation. "Well-annotated" generally implies that the samples come with strong accompanying metadata, such as clinical outcomes, treatment history, pathology information, follow-up data, specimen handling details, and other variables necessary to interpret biomarker performance credibly. The underlying idea is that clinical validation depends heavily on specimen quality, clear case definitions, and the ability to link assay outputs to clinically relevant endpoints.

The FOA also pushes applicants toward a deliberately multidisciplinary project structure. It encourages close collaboration among assay developers, disease-area clinicians, clinical laboratory professionals, and statisticians. Clinical laboratory scientists are highlighted because a major barrier to translation is often the gap between research-grade assays and the realities of clinical lab operations, including standard operating procedures, quality systems, sample logistics, and analytical rigor. Statistical experts are emphasized because validation studies frequently fail when they are underpowered, poorly designed, or analyzed in ways that inflate performance. Strong applications under this program would typically present clear validation plans, predefined performance metrics, thoughtful cohort selection, and appropriate statistical methods to test sensitivity, specificity, predictive value, reproducibility, and generalizability where relevant.

Just as important as what the FOA funds is what it does not fund. It is not intended for early-stage technology development, exploratory biomarker discovery, or basic feasibility work where the assay is still being invented. It is also not intended to pay for conducting clinical trials, and the R01 Clinical Trial Not Allowed designation reinforces that point. Instead, the funded work should bring an assay to a point where it can be realistically integrated into future clinical trials as an investigational assay, tool, or device, meaning it is ready to be deployed in a controlled clinical research setting with credible performance evidence behind it.

In terms of administrative and eligibility details, the opportunity is categorized as a discretionary grant, administered by NIH, under CFDA number 93.394. A wide range of organizations can apply, including state, county, and local governments; public and private institutions of higher education; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (including those other than small businesses); and small businesses. Eligibility also explicitly encompasses a broad set of institution types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian serving institutions, and Asian American Native American Pacific Islander Serving Institutions, as well as faith-based or community-based organizations, U.S. territories or possessions, and certain non-U.S. entities. This broad eligibility is consistent with the translational, team-based nature of assay validation, which can occur in academic labs, clinical lab environments, consortia settings, or partnerships that span sectors.

The announcement lists an award ceiling of $150,000, indicating a relatively constrained budget compared with many R01 projects, which aligns with the intent to support targeted revision work that builds on an existing parent grant rather than launching a large new research program. The FOA was created on December 10, 2019, and the original closing date shown is October 28, 2022, which is important for planning purposes because applicants would need to verify whether the FOA is still active or has been reissued under an updated number.

Overall, this FOA is best understood as a bridge program: it supports the focused, methodical validation work that often sits between a promising NIH-funded biomarker assay and its credible use in clinical research settings. The strongest fit is for teams that already have an assay with strong preliminary evidence and now need clinical-grade validation using high-quality specimens, rigorous statistics, and clinical laboratory expertise so the assay can be deployed as an investigational tool in subsequent clinical studies.

• 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 2019-12-10.
• Applicants must submit their applications by 2022-10-28. (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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