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

National Institutes of Health

PAR-24-304

HHS-NIH11

General Information

Est. Program Funding:

October 14, 2026

Closing Date:

Expected No. of Awards

Award Ceiling

Opportunity Number:
PAR-24-304

Owning Agency:
HHS-NIH11

Opportunity Category:
Discretionary (D)

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.

Response Date	Oct 14, 2026 12:00:00 AM EDT
Posting Date	Oct 10, 2024 12:00:00 AM EDT
Archive Date	Nov 19, 2026 12:00:00 AM EST
Award Ceiling
Award Floor
Cost Sharing	No

Eligibility

Eligible Applicants

Special district governments, Independent school districts, Small businesses, Public housing authorities/Indian housing authorities, Native American tribal governments (Federally recognized), For profit organizations other than small businesses, Public and State controlled institutions of higher education, Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, County governments, Others (see text field entitled "Additional Information on Eligibility" for clarification), State governments, City or township governments, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Native American tribal organizations (other than Federally recognized tribal governments)

Additional Info on Eligibility:

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.

Additional Information

Agency Name	National Institutes of Health
Link to Additional Information:	https://grants.nih.gov/grants/guide/pa-files/PAR-24-304.html
Grantor Contact Information:	If you have difficulty accessing the full announcement electronically, please contact: GrantSolutions Help Desk Phone: 301-402-2541

CFDA Program(s)

93.394: Cancer Detection and Diagnosis Research
:

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