Assay Validation For High Quality Markers For NCI Supported Clinical Trials (UH3) | Apply Online

Opportunity Summary:

The grant opportunity "Assay Validation For High Quality Markers For NCI Supported Clinical Trials (UH3)" (Funding Opportunity Number PAR 15 096) is a National Institutes of Health (NIH) initiative, aligned with the National Cancer Institute (NCI), focused on strengthening the pipeline for molecular diagnostics used in cancer research and care. Its central goal is to move cancer-related biomarker assays beyond basic development and into robust clinical validation so they can be trusted and deployed within the context of NCI-supported clinical trials and related research settings. The emphasis is on improving the quality, reliability, and real-world readiness of assays intended to guide cancer treatment decisions, monitor response, stratify risk, or support cancer control and prevention strategies.

This FOA is specifically designed for projects where the assay already exists in a meaningful, technically mature form. Applicants are expected to come in with an assay whose analytic performance has already been established, meaning the test has been analytically validated using specimens that are similar to the ones anticipated for the assay's intended clinical use. In other words, the program is not trying to fund early assay invention or basic feasibility. It is trying to fund the next, harder step: demonstrating that an established assay and marker can perform consistently and credibly when applied to clinical trial specimens and data, under conditions that resemble how the assay would actually be used in practice.

The funding mechanism is the UH3 cooperative agreement, which signals that the work is expected to be milestone-driven and carried out with substantial NIH/NCI involvement compared with a typical research project grant. Under this mechanism, the FOA supports clinical validation activities for up to three years. Importantly, the validation can use specimens and data from retrospective studies (using previously collected clinical trial specimens) or prospective studies (collecting or applying the assay moving forward), as long as they are tied to NCI-supported or other qualified clinical trials. The intent is to leverage the rigor and clinical annotation typical of trial settings to determine whether a biomarker assay is reliable and informative in a clinically relevant context.

The scope of markers covered is broad within cancer research needs. The FOA includes validation of prognostic markers (those associated with patient outcomes independent of treatment), predictive markers (those indicating likelihood of benefit or harm from a specific therapy), and response markers (those reflecting response to treatment). It also includes markers relevant to cancer control and prevention trials, which can involve risk assessment, early detection strategies, or other interventions aimed at reducing cancer burden. Another important feature is that projects may validate assays not only for a single immediate trial, but also to position an assay for use in future trials, observational studies, or different patient populations. That reflects a translational intent: to create assays that are portable and credible beyond one isolated dataset.

A key boundary of this FOA is what it does not fund. It is not intended to support clinical utility trials, meaning studies that test whether using the marker to make clinical decisions actually improves patient outcomes. Instead, it supports the work needed to get an assay to the point where such utility testing becomes feasible and scientifically justified. The program is essentially trying to close the gap between "this assay works in the lab" and "this assay is validated well enough that a utility trial is worth doing."

The FOA also makes clear that these projects are expected to be multidisciplinary by necessity. Successful assay validation in clinical trial contexts typically requires coordinated expertise across biomarker science, clinical oncology (or prevention/control specialties), biostatistics, and clinical laboratory operations. The announcement explicitly notes that clinical laboratory scientists and staff must be integrated into the application, and that laboratory technical needs and operational resources are not incidental but central. This reflects real-world assay validation realities: pre-analytic variables (collection, processing, storage), assay execution, quality control, reproducibility, and data handling all influence whether a marker can be considered high quality and trial-ready.

Administratively, the opportunity falls under the NIH category of discretionary funding and uses a cooperative agreement funding instrument type. The activity area is listed under Education and Health, and it aligns with CFDA number 93.394 (Cancer Detection and Diagnosis Research). The posted and creation dates were January 21, 2015, with an original and final closing date of October 6, 2017, and an archive date of November 6, 2017. The listed award ceiling is $250,000, and there is no cost sharing or matching requirement indicated.

Eligibility is broad across many types of U.S.-based organizations, reflecting the collaborative nature of translational biomarker work. Eligible applicants include state and local governments, tribal governments and tribal organizations, public and private institutions of higher education, nonprofit organizations (including those with and without 501(c)(3) status), for-profit organizations (excluding the restriction that it is "other than small businesses" in one category while also listing small businesses separately as eligible), public housing authorities, special district governments, and a variety of mission-specific or identity-based institutions such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, and AANAPISI institutions. Foreign institutions (non-U.S. entities) and non-U.S. components of U.S. organizations are not eligible to apply, although foreign components as defined under NIH policy are allowed, which typically means certain international collaborations can be included if justified and compliant with NIH rules.

In practical terms, this FOA is aimed at teams that have already done the heavy lifting of building and analytically validating an assay and now need support to prove, with clinically grounded evidence, that the assay performs reliably in the kinds of specimens and settings where NCI trials operate. The end product the FOA is trying to produce is not a new biomarker hypothesis, and not a practice-changing clinical utility demonstration, but a rigorously validated assay-marker package that is ready to be taken into later-stage studies where clinical decision-making impact can be tested.

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