Diagnostics Accelerator: Peripheral Biomarkers Program

The Diagnostics Accelerator focuses on promoting the development of peripheral biomarkers for Alzheimer's disease and related dementias, emphasizing noninvasive modalities like blood, saliva, urine, and ocular markers. The program explicitly excludes CSF and neuroimaging biomarkers but supports their use for validation of other biomarkers. Funding priorities target biomarkers that show a plausible biological connection to disease pathophysiology, including areas such as vascular injury, neuroinflammation, neuroprotection, protein misfolding, synaptic integrity, mitochondrial function, and novel approaches with compelling biological rationale. The program encourages sharing clinical samples for biomarker validation and is open to all biomarker categories that could advance drug development for Alzheimer’s and related dementias. Applicants are expected to define the biomarker's intended clinical use and outline their path to commercialization, aligning with FDA-defined biomarker categories.