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

Opportunity Summary:

Assay Validation For High Quality Markers For NCI Supported Clinical Trials (Admin Supp) (PA-15-264) is a National Institutes of Health opportunity focused on pushing cancer-related molecular diagnostics closer to real-world clinical use. The central goal is to strengthen the development and validation of biomarker assays that could support cancer treatment decisions, disease control strategies, or prevention efforts. In practical terms, the program targets assays for markers that can help forecast prognosis, predict which patients are likely to benefit from a specific therapy, or measure response to treatment, along with markers relevant to cancer control and prevention trials. The emphasis is on making sure the assay is robust and ready to be used credibly in clinical-trial settings.

A key expectation is that applicants already have an assay that works in human specimens, and that there is a strong rationale for why the marker matters clinically and why it should be advanced into a clinical assay. Just having a promising concept is not enough here. The FOA is built around the idea that most of the analytical validation work should be essentially complete by the time the application is submitted. That means the assay should already have solid evidence for performance characteristics such as reliability, precision, and other analytic measures needed to trust the test result. The supplement support is intended to help move the assay into clinical validation with minimal additional analytical troubleshooting, so the funded work is aimed at confirming performance in clinical trial populations rather than inventing or heavily re-engineering the assay from scratch.

The announcement also highlights that funds may be used to obtain biospecimens from retrospective or prospective studies, including specimens coming from NCI-supported clinical trials or other trials. This is important because many biomarker validation efforts depend on access to well-annotated samples tied to outcomes and clinical data. The FOA explicitly expects clinical laboratory capacity to be built into the plan, meaning laboratory staff time, technical needs, and operational support are not optional add-ons. They are treated as core components of a credible validation effort, reflecting how assay validation is often limited by workflow, quality systems, and the ability to run assays consistently across many samples.

Another notable feature is flexibility in what kind of validation is being done. Projects may validate assays for use in additional cancer clinical trials, observational studies, or different populations, including efforts to validate an existing assay in a new context. Regardless of the specific use case, the work is expected to be multidisciplinary. The FOA calls out the need for interaction and collaboration among scientific investigators, clinicians, statisticians, and clinical laboratory scientists and staff, which signals that proposals should include thoughtful study design, statistical planning, and laboratory execution as an integrated package rather than isolated pieces.

At the same time, the FOA draws a clear boundary around what it is not meant to fund. It is not designed to support clinical trials intended to prove the clinical utility of a marker or assay, meaning it will not pay for studies whose purpose is to show that using the test changes patient outcomes or improves decision-making in practice. Instead, it supports development to the point where a marker assay is sufficiently validated that a separate, later trial could reasonably test clinical utility. In other words, this program sits in the critical middle stage between discovery and full implementation: taking a working, analytically validated assay and generating the clinical validation evidence needed to justify utility-focused trials.

Administratively, this is a discretionary grant opportunity in the area of cancer detection and diagnosis research (CFDA 93.394). The award ceiling is listed as $150,000, with no cost-sharing or matching requirement. The opportunity was posted May 18, 2015, with a closing date of July 8, 2018, and an archive date of August 8, 2018, indicating it is no longer open but remains a useful reference point for the types of projects NCI has supported in assay validation through administrative supplements.

Eligibility is broad and includes many types of U.S.-based organizations and governments, such as public and private institutions of higher education, nonprofits (including 501(c)(3) and certain non-501(c)(3) entities), for-profit organizations (including small businesses), and a wide range of state, local, tribal, territorial, and regional entities. The eligibility language also explicitly includes several categories of minority-serving institutions and community-based or faith-based organizations where applicable. Non-U.S. entities (foreign organizations and foreign institutions) are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible; however, foreign components as defined in the NIH Grants Policy Statement are allowed, which typically refers to specific foreign involvement under a U.S. applicant organization that meets NIH policy requirements.

Overall, PA-15-264 is best understood as targeted support for high-quality, trial-relevant assay validation work: it prioritizes assays already functioning in human samples, expects analytical validation to be largely in hand at submission, supports specimen acquisition tied to clinical studies, requires strong laboratory integration, and encourages team science so that validated markers can be positioned for later studies that test whether using the assay truly improves clinical outcomes.

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