Revision Applications for Validation of Biomarker Assays Developed Through NIH-Supported Research Grants (R01) | PAR 17 003

Opportunity Information: Apply for PAR 17 003

Revision Applications for Validation of Biomarker Assays Developed Through NIH-Supported Research Grants (R01) (PAR-17-003) is an NIH grant opportunity, led through the National Cancer Institute (NCI), aimed at speeding up the real-world clinical use of biomarker assays that were originally developed with NIH support. The central goal is not to invent brand-new biomarkers or exploratory technologies, but to take existing NCI-supported assays and push them through the practical steps needed for clinical validation so they can be credibly used in clinical research settings, particularly as investigational tools in clinical trials.

The FOA focuses on adapting and clinically validating assays tied to molecular, cellular, or imaging biomarkers relevant to cancer. This includes markers used for cancer detection and diagnosis, prognosis, ongoing monitoring of disease, and predicting response to treatment. It also includes biomarkers relevant to cancer control and prevention, which broadens the scope beyond treatment-only applications. In other words, the opportunity is meant to help move promising assays from the research bench into a form that can be relied upon in clinical environments, with evidence that the assay works as intended when applied to appropriate patient specimens and clinically meaningful questions.

A key feature of the opportunity is support for obtaining well-annotated human specimens that are appropriate for validation work. Applications may include plans to acquire samples from NCI-supported clinical trials or from other clinical trials, observational cohorts, and consortia, provided the specimens are sufficiently documented and suitable for evaluating the assay against clinical endpoints or reference standards. This reflects a practical reality of biomarker validation: strong clinical datasets and well-characterized specimens are often the main bottleneck, and validation depends heavily on specimen quality, consistent handling, and robust associated clinical data.

The FOA strongly encourages multi-disciplinary teams and expects projects to be structured around collaboration among assay developers and the clinical and analytical experts needed to validate an assay in a way that stands up to scrutiny. Clinicians, clinical laboratory staff, and statisticians are emphasized as important contributors, not optional consultants. The intent is to ensure that studies are designed with appropriate clinical context, that laboratory procedures reflect real clinical laboratory constraints, and that statistical planning is rigorous enough to support credible conclusions about assay performance, reproducibility, and potential utility.

This opportunity is explicitly not meant to pay for early-stage technology development or discovery work, and it is not intended to fund the conduct of clinical trials themselves. Instead, it sits in the middle translational space: taking an assay that already exists and supporting the adaptation and validation steps needed so the assay could be incorporated into future clinical trials as an investigational assay, tool, or device. That typically implies work such as standardizing assay procedures, improving robustness for clinical-grade workflows, establishing performance characteristics in clinically relevant specimens, and generating the evidence base needed for subsequent trial integration.

Administratively, it is offered as a discretionary grant under an R01 mechanism and is listed under CFDA 93.394. The funding listing shows an award ceiling of $150,000 and an original closing date of October 28, 2019, with the record created on October 4, 2016. Eligible applicants are broad and include many common NIH-eligible organization types: state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (other than small businesses); small businesses; and other categories. The FOA also highlights additional eligible groups such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving institutions, HBCUs, tribally controlled colleges and universities, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, eligible federal agencies, and even non-U.S. entities (foreign organizations), reflecting an inclusive eligibility posture so long as the project goals match the clinical validation emphasis.

Overall, the opportunity is best understood as a translational accelerator for cancer biomarker assays: it supports the careful, team-based validation work needed to demonstrate that an NIH-developed assay can function reliably with clinically relevant samples and generate results robust enough to justify its use as an investigational assay in later clinical trial settings, without paying for the trial itself or for early discovery-stage assay invention.

• 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)" 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 2016-10-04.
• Applicants must submit their applications by 2019-10-28. (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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