As the only optically accessible part of the central nervoussystem, the retina represents a unique opportunity for the detection ofbiomarkers for Alzheimer’s disease (AD). Optina Diagnostics developed a digitalbiomarker platform, the Optina Retinal Deep Phenotypic^TM (RDP^TM) platform,comprising an already 510(k) approved hyperspectral retinal camera and a proprietarymachine-learning approach to extract hundreds of unique spatial/spectralphenotypic features from data-rich retinal images, identifying subtle changesthat may not be visible to the naked eye. These phenotypic features and changescan be correlated with a given condition, such as AD pathology. OptinaDiagnostics’ first application on the RDP^TM platform is the awAIr^TM-CAStest. The test identifies sets of phenotypic features from the hyperspectral retinalscan that highly correlate with the cerebral amyloid status, using the amyloidPET scan as the ground truth. The awAIr^TM-CAS test was granted FDABreakthrough Device Designation and is currently at the validation stage with apivotal study in the process of being completed. Optina Diagnostic’ goal is to providea more accessible mean to detect this key hallmark of AD.

The principal objective of the proposed research program isto establish the clinical value of the Optina Diagnostics’ awAIr^TM-CAStest based on hyperspectral retinal imaging. More specifically, the proposedproject aims to:

AIM 1: Receive product clearance for the awAIr^TM-CAStest based on hyperspectral retinal imaging. This milestone will solidify thetest's credibility and pave the way for widespread adoption and usage.

AIM 2: Develop and conduct a registry study to support thevalue proposition for reimbursement of the awAIr^TM-CAS test. Byestablishing its clinical efficacy and economic benefits, Optina Diagnosticsaims to ensure widespread accessibility to this groundbreaking diagnostic tool.