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Revision Applications for Validation of Biomarker Assays Developed Through NIH-Supported Research Grants (R01 Clinical Trial Not Allowed)

Federal funding opportunity PAR-24-304 from National Institutes of Health (Department of Health and Human Services).

Apply on Grants.gov →Application closes October 14, 2026

Posted
October 10, 2024
Closes
October 14, 2026
Cost sharing
No
Instrument
Grant
Assistance listing
93.394
Category
Education, Health
Archives
November 19, 2026

Program funding history

Awards made under Assistance Listing 93.394 across FY2024–FY2026, from public federal spending records.

FY2024 obligated
$533.3M
FY2025 obligated
$595.6M
FY2026 (to date) obligated
$227.4M
Awards in window
2,123

Top recipients: Regents of the University of California, San Francisco, the, Fred Hutchinson Cancer Center, The Johns Hopkins University, The Leland Stanford Junior University, Sloan-kettering Institute for Cancer Research

Source: USAspending.gov · refreshed July 2026

Synopsis

Through this Notice of Funding Opportunity (NOFO) is to accelerate the pace of translation of NCI-supported methods/assays/technologies (referred to as "assays") to the clinic. Specifically, the focus of this NOFO is on the adaption and clinical validation of molecular/cellular/imaging markers (referred to as "markers" r "biomarkers") for cancer detection, diagnosis, prognosis, monitoring, and prediction of response in treatment, as well as markers for cancer control and prevention. Research applications may support the acquisition of well-annotated specimens from NCI-supported or other clinical trials or observational cohorts/consortia for the purpose of clinical validation of the assay. Research projects proposed for this NOFO encourage multi-disciplinary interaction among scientific investigators, assay developers, clinicians, statisticians, and clinical laboratory staff. Clinical laboratory scientist(s) and statistical experts are highly encouraged to comprise integral parts of the application. This NOFO is not intended to support early-stage development of technology or the conduct of clinical trials, but rather the adaption and validation of assays to the point where they could be integrated into clinical trials as investigational assays/tools/devices.

Who can apply

Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession.

How to apply

Applications go through the official government listing. Grants Radar links you straight to the source.

View on Grants.gov   Full announcement

Agency contact: National Institutes of Health · grantsinfo@nih.gov · 301-402-2541

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