Program to Assess the Rigor and Reproducibility of Extracellular Vesicle-Derived Analytes for Cancer Detection (R01 Clinical Trial Not Allowed) | PAR 20 053

Opportunity Information: Apply for PAR 20 053

The National Institutes of Health (NIH) funding opportunity PAR-20-053, titled "Program to Assess the Rigor and Reproducibility of Extracellular Vesicle-Derived Analytes for Cancer Detection (R01 Clinical Trial Not Allowed)," supports research projects aimed at improving how extracellular vesicles (EVs) and their molecular cargo are isolated, characterized, and analyzed for early cancer applications. The scientific emphasis is on EV-derived analytes as a source of predictive biomarkers that could strengthen cancer risk assessment, earlier detection, diagnosis, and prognosis, particularly in early-stage disease settings where reliable biomarkers are often hardest to establish. While the end goal is to enable stronger cancer biomarker discovery, the core focus is methodological: developing and testing approaches that make EV-based measurements more trustworthy, comparable across studies, and reproducible in independent labs.

A central theme of the announcement is rigor and reproducibility in two connected areas. First, it encourages research that examines the EV isolation and characterization process itself, including innovative methods and careful evaluation of variables that affect EV yield, purity, and composition. This includes the practical reality that EV preparations can differ dramatically depending on sample type, handling conditions, isolation technique, and quality controls. The FOA is therefore positioned to support work that identifies sources of technical variability, establishes or evaluates standards and controls, and clarifies which isolation and characterization strategies are best suited for specific downstream biomarker questions. Second, it highlights rigor and reproducibility in computational analysis of EV cargo, recognizing that bioinformatic and statistical pipelines can introduce their own biases and inconsistencies. Projects responsive to this FOA would be expected to address the reliability of computational workflows used to interpret EV cargo signals (for example, nucleic acids, proteins, lipids, or other molecular features), with an emphasis on transparent, repeatable analytic approaches that can be independently validated.

The mechanism is an NIH R01 research project grant, and the FOA explicitly indicates "Clinical Trial Not Allowed," meaning applicants should not propose studies that meet NIH’s definition of a clinical trial. The supported work is best understood as preclinical, analytical, and discovery-oriented research focused on assay and analysis rigor rather than interventional testing in human participants. The funding activity category is listed under education and health, and the CFDA number associated with the opportunity is 93.394.

Eligibility is broad and includes many common applicant types across government, academia, nonprofit, and industry. Eligible applicants include state, county, city/township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other Native American tribal organizations; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses) as well as small businesses; and other organizations meeting NIH eligibility requirements. The announcement also highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), 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 (non-U.S.) entities (foreign organizations). In practice, this breadth signals NIH interest in wide participation and in building a research base that can produce broadly usable, well-validated EV methods and analyses.

Key administrative details from the source information include an NIH origin, a creation date of 2019-11-12, and an original closing date listed as 2023-01-07. The award ceiling and expected number of awards are not specified in the provided source data, which typically means applicants should consult the full FOA and NIH institute/center-specific guidance for budget expectations, paylines, and programmatic priorities. Overall, PAR-20-053 is essentially a targeted R01 call for research that makes EV-based cancer biomarker work more dependable by tightening the experimental and computational foundations needed for findings to hold up across different laboratories, datasets, and study contexts.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Program to Assess the Rigor and Reproducibility of Extracellular Vesicle-Derived Analytes for Cancer Detection (R01 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.
• This funding opportunity was created on 2019-11-12.
• Applicants must submit their applications by 2023-01-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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 20 053

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: