FDA grants designation for eye scan that could aid Alzheimer’s diagnosis

A Montreal-based company has received Breakthrough Device Designation from federal agency for a retinal imaging platform that could inexpensively test patients for the early physical indications of Alzheimer’s disease.

The Food and Drug Administration has granted Breakthrough Device Designation to the retinal imaging platform being developed by Optina Diagnostics.

The approach seeks to use images obtained during simple eye scans and then employ artificial intelligence to analyze those images for the detection of likely positron emission tomography amyloid status, either negative or positive, to aid in the evaluation of patients with cognitive impairment.

The company sees its platform as an adjunct to other diagnostic evaluations.



Amyloid PET is the standard way to detect amyloid plaques in the brain, a key indicator of Alzheimer's disease; researchers believe the test may be useful to confirm the diagnosis and optimize the management of patients being evaluated for Alzheimer's disease and other causes of cognitive decline.

But the problem is that amyloid PET is an expensive technique that’s not widely used in clinical practice; as a result, Alzheimer's disease is mostly diagnosed based on clinical symptoms, without evaluation of the amyloid status. That’s a hit-and-miss approach, leading to incorrect diagnosis for nearly one third of the patients who have cognitive impairment, as well as nearly half of those presenting with ambiguous cases.

Optina Diagnostics is working towards a non-invasive and more accessible approach via a simple eye imaging test to improve the diagnosis accuracy and management of patients evaluated for Alzheimer's disease or other form of cognitive decline.

Optina Diagnostics' technology is based on data-rich hyperspectral retinal imaging combined with AI. “This opens tremendous possibilities to have insights into the brain non-invasively and at a low cost,” contends David Lapointe, CEO of Optina Diagnostics. “The Optina Diagnostics technology could also be helpful to accelerate and reduce the cost for the enrollment of participants that are really on the Alzheimer's path to conduct clinical trials for disease-modifying drugs for Alzheimer's disease."

The FDA’s Breakthrough Device Program is a voluntary program for certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversible debilitating diseases or conditions. This program is designed to expedite the development and review of these medical devices.