The purpose of this Notice of Funding Opportunity (NOFO) is to promote the development of fit-for-purpose candidate biomarkers and composite biomarker that enable more efficient clinical trials advance therapeutic development or clinical practice help guide clinical care decisions. Specifically, the goal of this phased funding mechanism is to first identify or confirm candidate biomarker(s) or biomarker signatures using human samples and/or data, followed by an independent retrospective or prospective clinical study to conduct initial clinical validation of the biomarker/signature’s clinical utility for one or two defined Context(s) of Use. In the first phase, applicants are expected to demonstrate that the biomarker acceptably identifies or predicts the concept of interest and may include optimization of the detection method using carefully standardized human samples or datasets. The overarching purpose of this initiative is to deliver candidate biomarkers or biomarker signatures that are ready for definitive analytical and clinical validation studies.
This Notice of Funding Opportunity (NOFO) requires a Plan for Enhancing Diverse Perspectives (PEDP).
Deadlines:
- Letter of Intent Due Date(s): 30 days prior to the application due date
- Application Due Date(s): Feb 21, 2025; June 20, 2025; Oct 20, 2025; Feb 20, 2026; June 22, 2026; Oct 20, 2026; Feb 22, 2027; June 21, 2027; Oct 20, 2027
- AIDS Application Due Date(s): Jan. 7, May 7, Sep. 7
PAR-25-024 Expiration Date January 08, 2028