Assessment of an Innovative Test for Cerebral Amyloid Status in Alzheimer's Disease Diagnosis and Management: Optina's Landmark REPHRASE Study

Tuesday, July 18, 2023

Optina Diagnostics is currently conducting the REPHRASE study, which aims to revolutionize the diagnosis and management of Alzheimer's Disease (AD). This innovative study focuses on validating the awAIr™-Cerebral Amyloid Status (CAS) test, developed by Optina Diagnostics, to provide physicians with definitive information about Alzheimer's pathology. The goal is to improve the management of cognitive impairments associated with the disease.

The REPHRASE study is a landmark initiative by Optina Diagnostics, aiming to validate the effectiveness of the awAIr™-CAS test in diagnosing and managing Alzheimer's Disease. By leveraging the unique characteristics of the retina, which is part of the central nervous system, Optina's test offers a non-invasive way to detect changes associated with Alzheimer's disease.

Alzheimer's disease is a growing crisis, with an increasing number of individuals affected. Optina Diagnostics recognizes the need for early diagnosis to provide better treatment outcomes. The company's dedicated team is focused on reducing the time required for accurate diagnosis.
Optina Diagnostics will be presenting the findings of the REPHRASE study at the Alzheimer's Association International Conference (AAIC 2023) in Amsterdam from July 16 to 20.

The current diagnostic approach for Alzheimer's disease is costly and inefficient. However, Optina's awAIr™-CAS test represents a significant breakthrough. Recognized by the FDA through its Breakthrough Device designation program, this test offers a non-invasive and effective method for identifying early signs of Alzheimer's disease.

Through the REPHRASE study, Optina aims to introduce a groundbreaking approach to Alzheimer's diagnosis. This study will enable earlier detection of the disease, leading to improved disease management and the potential for new treatment modalities.

The REPHRASE study involves adults over 50 years old who exhibit cognitive impairment symptoms consistent with potential Alzheimer's disease. The study is being conducted at renowned clinical sites, including the Cleveland Clinic, Lou Ruvo Center for Brain Health; East Virginia Medical School, Glennan Center for Geriatrics and Gerontology; University of Washington, Memory and Brain Wellness Center; Ezy Medical Research; Sunnybrook Health Sciences Center; Ottawa Memory Clinic / Clinique Mémoire d'Outaouais; and Centricity Research.

David Lapointe, CEO of Optina, emphasizes the significance of the REPHRASE study in advancing early detection and treatment of Alzheimer's disease. The study utilizes the eye as an accessible way to diagnose the disease in its early stages, providing hope for improved outcomes.
A participant in the REPHRASE study expressed gratitude for the opportunity to contribute to research and the potential impact it may have on diagnosing Alzheimer's disease earlier.

The anticipated completion of the study by Q4 2023 represents a significant milestone towards FDA clearance and commercialization of the awAIr™-CAS test. This breakthrough has the potential to transform Alzheimer's diagnosis and treatment.
The REPHRASE study received partial funding from the Alzheimer's Drug Discovery Foundation's (ADDF) Diagnostics Accelerator program.


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