Funding Opportunities

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.