Precompetitive Collaboration on Liquid Biopsy for Early Cancer Assessment: Liquid Biopsy Research Laboratories (U01 Clinical Trial Not Allowed) | RFA CA 23 018

Opportunity Information: Apply for RFA CA 23 018

The NIH funding opportunity RFA-CA-23-018, titled "Precompetitive Collaboration on Liquid Biopsy for Early Cancer Assessment: Liquid Biopsy Research Laboratories (U01 Clinical Trial Not Allowed)," supports the creation of an academic-industrial partnership program aimed at advancing liquid biopsy science for earlier and more reliable cancer assessment. The central focus is on developing new technologies and/or validating existing tools, methods, and assays that can capture and quantify tumor-associated materials found in body fluids. These tumor-related signals include circulating tumor cells and other tumor-associated cells, as well as tumor-derived DNA, RNA, and exosomes. The overarching clinical goal is to improve detection and characterization of cancer in people with early-stage disease or those considered high risk, and to strengthen the ability of liquid biopsy approaches to distinguish cancer from benign conditions or to differentiate aggressive cancers from indolent ones.

A key feature of this program is the emphasis on precompetitive collaboration with industry. In practice, that means participants are expected to work in alliances that prioritize shared validation and harmonization rather than proprietary, siloed development. The opportunity is designed to help align how liquid biopsy technologies are evaluated and compared across platforms, laboratories, and settings, with the intention of producing results that are reproducible and broadly useful. By supporting harmonization and validation, the initiative aims to reduce variability in assay performance and interpretation, which is a major barrier to translating promising liquid biopsy findings into dependable real-world tools for early cancer assessment.

The award mechanism is a U01 cooperative agreement, which typically indicates substantial scientific or programmatic involvement by NIH staff compared with a standard research grant. While the supported work is research-focused, the announcement explicitly states "Clinical Trial Not Allowed," meaning applicants must structure projects so they do not meet NIH’s definition of a clinical trial. The funding instrument and activity category are listed under discretionary funding, with an education and health activity category, and associated CFDA numbers 93.394 and 93.396. The listed award ceiling is $600,000, and the original closing date for applications was January 10, 2023, with the opportunity created on October 31, 2022.

Eligibility is broad and includes many types of domestic organizations and government entities. Eligible applicants include state, county, city or township governments, special district governments, and independent school districts, as well as public and state-controlled institutions of higher education and private institutions of higher education. Tribal eligibility includes federally recognized Native American tribal governments and Native American tribal organizations other than federally recognized tribal governments. Housing-related public authorities (including Indian housing authorities) are also eligible. Both nonprofit organizations (with or without 501(c)(3) status) and for-profit organizations (other than small businesses), as well as small businesses, may apply. The opportunity also highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), 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, and U.S. territories or possessions.

At the same time, the opportunity places clear limits on foreign participation. Non-domestic (non-U.S.) entities and non-domestic (non-U.S.) institutions are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components as defined by the NIH Grants Policy Statement are allowed, which generally means a U.S.-based applicant can include certain foreign activities or collaborators when well-justified and compliant with NIH policy, even though a foreign organization cannot be the primary applicant.

Taken together, this grant opportunity is meant to accelerate the field of liquid biopsy for early cancer assessment by building structured, collaborative research laboratories that work with industry in a precompetitive way. The program’s priorities center on rigorous development and validation of assays and methods for tumor-associated biomarkers in body fluids, improving consistency and comparability of results across technologies, and ultimately strengthening the scientific foundation needed for reliable early detection and cancer risk assessment tools.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Precompetitive Collaboration on Liquid Biopsy for Early Cancer Assessment: Liquid Biopsy Research Laboratories (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): 93.394, 93.396.
• This funding opportunity was created on 2022-10-31.
• Applicants must submit their applications by 2023-01-10. (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 $600,000.00 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 RFA CA 23 018

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