Integrating Biospecimen Science Approaches into Clinical Assay Development (U01 Clinical Trial Not Allowed) | PAR 22 049

Opportunity Information: Apply for PAR 22 049

Integrating Biospecimen Science Approaches into Clinical Assay Development (U01 Clinical Trial Not Allowed) is a National Institutes of Health (NIH) funding opportunity (PAR-22-049) that supports extramural research focused on a persistent problem in biomarker and clinical assay development: preanalytical variability. In practical terms, the FOA is aimed at understanding how differences in the way biospecimens are collected, handled, processed, and stored before testing can distort or destabilize the measurement of clinically relevant biomarkers. By funding investigator-designed studies that map these effects in a rigorous way, the program is intended to reduce uncertainty during analytical validation and speed up the path from biomarker discovery to reliable clinical assays.

The scientific scope is deliberately broad in terms of specimen types and real-world collection contexts. The FOA highlights tumor tissue biopsies and blood used for "liquid biopsy" applications, but it also explicitly includes many other sample types that are increasingly important for emerging diagnostics and monitoring approaches. Examples named in the announcement include small biopsies (such as core biopsies and small excision samples), tissue swabs, tissue secretions, pleural and esophageal aspirates, feces, and a range of bodily fluids including sweat, urine, cerebrospinal fluid (CSF), breast milk, and saliva. This emphasis signals that NIH is looking for evidence that is directly relevant to clinical workflows, especially where samples may be small, fragile, heterogeneous, or collected under variable conditions across sites.

Projects supported under this FOA are expected to use controlled experiments to test how specific preanalytical conditions influence biomarker readouts on different measurement platforms. That can include, for instance, studying how collection device choice, anticoagulant type, time-to-processing, temperature exposure, fixation or stabilization methods, centrifugation steps, freeze-thaw cycles, shipping conditions, storage duration, or container materials change measured values. The FOA is platform-agnostic in the sense that it anticipates biomarkers being quantified by "a variety of testing platforms," which can reasonably include molecular assays (DNA/RNA-based), proteomic or metabolomic measurements, immunoassays, and other clinically relevant analytical technologies, as long as the focus is on analytical implications of preanalytical variability rather than running an interventional clinical trial.

The main deliverable value of this program is practical and translational: generate evidence that clarifies which preanalytical variables matter most for specific biomarker classes and specimen types, and what handling practices reduce bias and improve reproducibility. The FOA frames the end goal as expediting clinical assay development through evidence-based standardization of biopsy and biospecimen handling practices. In other words, the program is trying to move the field away from informal or site-specific handling habits toward standardized procedures that are justified by data and that can be adopted in multi-site clinical and laboratory settings.

Administratively, the award mechanism is a Cooperative Agreement (U01), which typically means NIH expects substantial involvement from program staff compared with a standard research project grant. While the details of that involvement are not included in your excerpt, applicants should generally anticipate coordination, milestone-driven progress, and active communication with NIH as part of the cooperative structure. The FOA is explicitly labeled "Clinical Trial Not Allowed," so proposed work must avoid clinical trial designs as defined by NIH and instead stay centered on biospecimen science, assay development support, and analytical validation-relevant preanalytical studies.

Eligibility is broad and includes many types of U.S. and non-U.S. organizations. Eligible applicants listed include state, county, city or township governments, special district governments, independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, Native American tribal governments (federally recognized), tribal organizations (other than federally recognized tribal governments), public housing authorities/Indian housing authorities, nonprofits with or without 501(c)(3) status (other than higher education institutions), for-profit organizations other than small businesses, and small businesses. The FOA also specifically calls out additional eligible groups such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-domestic (foreign) entities.

Key administrative details from the source data include the NIH agency sponsor, assistance listing (CFDA) number 93.393, an original closing date of 2024-09-13, and an award ceiling of $250,000. The opportunity was created on 2021-10-21. The expected number of awards is not provided in the excerpt. Overall, this FOA is best read as a targeted investment in the "last mile" of biomarker translation, where controlling preanalytical noise and documenting robust handling standards can make the difference between a promising biomarker and a clinically dependable assay.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Integrating Biospecimen Science Approaches into Clinical Assay Development (U01 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): 93.393.
• This funding opportunity was created on 2021-10-21.
• Applicants must submit their applications by 2024-09-13. (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 $250,000.00 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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