Assay Validation For High Quality Markers For NCI Supported Clinical Trials (UH2/UH3) | Apply Online

Opportunity Summary:

The NIH, through the National Cancer Institute (NCI), offered this cooperative agreement funding opportunity (PAR-15-095) to push promising cancer-related molecular diagnostics further along the path toward real-world use in NCI-supported clinical trials. The central goal was to strengthen the development and validation of assays for biomarkers that could guide cancer treatment decisions or support cancer control and prevention research. The FOA focused on moving beyond early discovery by funding the work needed to show that an assay is reliable and fit for clinical research settings, so that later studies could meaningfully evaluate whether using the marker actually improves patient outcomes.

A key expectation was that applicants already have an assay that works in human specimens and that the marker’s clinical importance is convincingly justified. In other words, this was not meant for exploratory biomarker hunting or purely preclinical work. Instead, it targeted assays with a strong rationale and a clear plan to become clinical-grade tools. The FOA explicitly covered different kinds of markers, including prognostic markers (associated with patient outcomes regardless of therapy), predictive markers (associated with likelihood of benefit from a particular therapy), and response markers (associated with treatment response). It also welcomed markers relevant to cancer prevention or cancer control trials, not just therapeutic studies.

The award structure used a two-phase mechanism, UH2 followed by UH3, and applicants had to address both phases in a single application. The UH2 phase (up to two years) supported analytical validation, meaning the rigorous laboratory work needed to demonstrate that the assay performs consistently and accurately. This typically involves establishing performance characteristics such as sensitivity, specificity, accuracy, precision and reproducibility, robustness to pre-analytic variables (like collection, handling, and storage), limits of detection/quantitation where relevant, and quality control procedures. The idea was that only after meeting pre-specified analytical benchmarks could a project transition into the next stage.

The UH3 phase (up to three years) supported clinical validation, which generally means evaluating whether the analytically validated assay result is associated with the clinical state or outcome of interest in an appropriate patient population. Under this FOA, clinical validation could be performed using specimens from retrospective or prospective studies, including specimens derived from NCI-supported clinical trials or other well-justified trials. Importantly, the FOA emphasized that this program was not intended to fund trials designed to prove clinical utility (for example, studies showing that using the marker to make decisions improves survival, reduces toxicity, or changes management in a beneficial way). Instead, the aim was to bring assays to a level of maturity where a future trial could responsibly test clinical utility.

Because the mechanism was a cooperative agreement, NCI involvement was expected to be more hands-on than with a standard grant, often implying substantial programmatic coordination, milestone-driven progress, and active communication between awardees and NIH staff. The FOA also stressed that clinical laboratory expertise could not be an afterthought. Clinical laboratory staff, technical operations, and practical implementation needs were required elements in both the UH2 and UH3 plans. This reflects a real-world concern: many assays look promising scientifically but fail when confronted with the operational demands of standardized testing across time, sites, and specimen conditions.

The opportunity also highlighted the multidisciplinary nature of successful assay validation. Competitive projects were expected to bring together basic and translational scientists, clinicians, statisticians, and clinical laboratory professionals. That mix is critical because analytical validation requires deep technical assay knowledge, clinical validation requires appropriate clinical context and specimens, and the statistical design must match the intended use, endpoints, and sources of bias in retrospective and prospective collections. The FOA also allowed for assays that validate or refine existing methods so they can be deployed more broadly in other cancer clinical trials, observational studies, or specific populations, reinforcing the emphasis on generalizable, high-quality tools rather than one-off laboratory results.

Administratively, the opportunity was listed as discretionary funding using a cooperative agreement instrument, within the health activity category, and tied to CFDA 93.394 (Cancer Detection and Diagnosis Research). It did not require cost sharing or matching. Eligible applicants included a wide range of U.S.-based organizations such as public and private institutions of higher education, nonprofits (with or without 501(c)(3) status), for-profit organizations (including small businesses), and various governmental entities. The eligibility language also encompassed many mission-driven institution types (for example, HBCUs, Hispanic-serving institutions, tribal organizations, and other designated serving institutions). Non-U.S. (foreign) institutions and non-U.S. components of U.S. organizations were not eligible to apply, although foreign components as defined by NIH policy were allowed. The FOA was posted on January 21, 2015, and ultimately closed on October 6, 2017, with an archive date of November 6, 2017.

In practical terms, this FOA funded the hard, detail-heavy middle ground between biomarker discovery and decision-changing clinical trials. It aimed to produce assays that are analytically sound, clinically validated against appropriate specimens, and operationally realistic for use in NCI-supported research, setting the stage for later studies that could test whether using those assays actually improves care.

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