Integrating Biospecimen Science Approaches into Clinical Assay Development (U01 Clinical Trial Not Allowed) | PAR 18 947

Opportunity Information: Apply for PAR 18 947

This NIH funding opportunity, titled "Integrating Biospecimen Science Approaches into Clinical Assay Development (U01 Clinical Trial Not Allowed)" (PAR-18-947), is aimed at a very specific but widely felt bottleneck in cancer biomarker testing: preanalytical variability. In plain terms, the program is focused on the ways that routine, real-world differences in how tumor tissue and blood samples are collected, handled, processed, and stored can distort biomarker measurements. Those distortions can then ripple forward into clinical assay development and analytical validation, creating uncertainty about whether an assay is truly measuring biology or just reflecting how the sample was treated before it ever reached the lab. The FOA supports extramural research that produces evidence strong enough to guide practical standardization of handling practices, with the end goal of speeding up the development of reliable clinical biomarker assays.

The scientific emphasis is on tumor tissue biopsies and blood-based biospecimens used for liquid biopsy applications, particularly in settings where the sample is limited or fragile and therefore more sensitive to handling differences. The announcement highlights small biopsy types such as core biopsies and small excision samples, as well as pleural aspirates, alongside blood specimens used for downstream liquid biopsy measurements. The research supported under this FOA is intended to directly test how specific preanalytical conditions influence the measurement of emerging and clinically relevant biomarkers across different assay technologies. That means applicants are expected to design experiments that deliberately vary relevant preanalytical factors (for example, collection methods, time-to-processing, temperature exposure, fixation conditions, centrifugation approaches, tube types, storage duration, freeze-thaw cycles, and similar variables) and then quantify how those choices affect biomarker readouts on one or more platforms.

A key point is that this is not a broad discovery biomarker program, and it is not funding clinical trials. It is a cooperative agreement (U01), which typically means NIH expects substantial involvement and coordination with awardees as the work progresses, often to keep methods rigorous, comparable, and aligned with program goals. The overall payoff NIH is looking for is practical, evidence-based guidance that improves consistency and interpretability of biomarker measurements. By mapping which preanalytical variables matter most, and under what conditions, the work should reduce uncertainty during assay development and validation, lower the chance of irreproducible results across sites, and help clinical labs and developers adopt standardized handling workflows that preserve the integrity of the biomarkers being measured.

From an applicant and eligibility standpoint, the FOA is open to a wide range of U.S.-based organizations, reflecting NIH's intent to attract methodologically strong teams from academia, healthcare systems, nonprofits, government entities, and industry. Eligible applicants include state, county, city/township, and special district governments; public and state-controlled and private institutions of higher education; independent school districts; federally recognized tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses) and small businesses; and other organizations. The FOA also explicitly calls out categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. At the same time, it clearly restricts foreign involvement: non-U.S. entities (foreign organizations and foreign institutions) are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components as defined by NIH policy are not allowed.

Administratively, the opportunity is listed as discretionary funding through NIH under CFDA numbers 93.393 and 93.394, using the cooperative agreement mechanism. The source data indicates an award ceiling of $250,000 and lists the original closing date as 2021-07-11, with a creation date of 2018-09-28. Taken together, the FOA is essentially a targeted investment in biospecimen science as an enabling foundation for clinical testing, pushing the field toward stronger standardization and more dependable analytical performance when biomarkers are measured from small tissue biopsies and liquid biopsy specimens.

• 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, 93.394.
• This funding opportunity was created on 2018-09-28.
• Applicants must submit their applications by 2021-07-11. (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.

Apply for PAR 18 947

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