The FDA has granted Optina Diagnostics’ retinal-imaging platform (CAPRS1/MHRC2) a breakthrough device designation. Using artificial intelligence (AI), the platform analyzes hyperspectral retinal images captured by MHRC during a simple eye scan.
The platform is designed to detect likely positron-emission tomography (PET) amyloid status to assist in the evaluation of cognitively impaired adults who are being assessed for Alzheimer’s disease (AD) and other causes of cognitive decline.
Amyloid PET, the standard method for finding amyloid plaques in the brain, a key feature of AD, is an expensive technique with limited accessibility. Thus, in clinical practice, diagnosing AD is primarily based on clinical symptoms, without evaluation of amyloid status. This results in an incorrect diagnosis for almost one-third of patients with cognitive impairment and for half of patients with ambiguous cases.
Optina Diagnostics technology provides a non-invasive, low-cost, and more accessible means of improving the diagnosis accuracy and management of patients evaluated for AD or other forms of cognitive decline.
For patients who are at risk of developing Alzheimer’s, the technology could also help to accelerate the process and lower the cost of enrolling participants in clinical trials for disease-modifying drugs.
By 2050, Alzheimer’s, the sixth-leading cause of death in the U.S., is predicted to affect 14 million people, due to aging population demographics.
Source: BioSpace, May 9, 2019