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

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

credit: Run Luau Run


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.
Related Programs

Cancer Detection and Diagnosis Research

Department of Health and Human Services



Relevant Nonprofit Program Categories





Obtain Full Opportunity Text:
https://grants.nih.gov/grants/guide/pa-files/PAR-24-304.html

Additional Information of 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.

Full Opportunity Web Address:
http://grants.nih.gov/grants/guide/pa-files/PAR-24-304.html

Contact:


Agency Email Description:
See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.

Agency Email:


Date Posted:
2024-10-10

Application Due Date:


Archive Date:
2026-11-19



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