Optina’s Retinal Deep Phenotyping platform
The development of a next-generation diagnostic platform that simply diagnoses Alzheimer's disease through the retina of the eye is expected to start soon.
Current validated biomarkers like PET scan and CSF study are not broadly available due to cost and invasiveness. Several blood-based approaches to measure biomarkers like beta-amyloid and tau have recently been proposed and some have shown promising results. However, blood may not always reflect exactly what is happening in the brain.
The retina is a light-sensitive layer of tissue lining the back of the eye and provides accurate insight into neuropathology inside the brain. So, retinal scan can take advantage of being able to easily determine whether amyloid plaques in the brain have formed, which could be detected through expensive PET imaging tests.
According to the related industry, Optina Diagnostics, an innovative diagnostics company leading the field of Retinal Imaging, has recently received a large-scale venture capital investment to develop an AI-based diagnostic platform for Alzheimer's disease diagnosis.
The Optina’s Retinal Deep Phenotyping platform received breakthrough device designation from the U.S. Food and Drug Administration (FDA) in June 2019 to aid in the diagnosis of Alzheimer’s, and the hyperspectral retinal camera was also approved for use by the FDA in May 2020.
The diagnostic platform called ‘Retinal Deep Phenotyping platform’ is based on a hyperspectral camera and an artificial intelligence (AI) algorithm capable of machine learning and can detect biological signals related to dementia.
A hyperspectral camera can detect and process the cerebral amyloid status reflected in the retina as based on PET imaging and process at very high speeds. Next, the machine learning algorithm analyzes the obtained retinal images and finds the signs of Alzheimer's.
The potential value was reflected in the platform development and Optina Diagnostics closed a Series-A round of CA$24.8 million in October 2021.
Series-A investments was led by DigitalDx Ventures and supported by Boehringer Ingelheim Venture Capital. Other investors include Desjardins Capital and Hike Ventures, Advisors Fund, MEDTEQ+, and Biomed Propulsion.
Optina said in a public notice on November 1st, "There is no single diagnostic method that has obtained regulatory approval for the purpose of diagnosing Alzheimer's disease.", and “Therefore, it may take several months or even years for the final diagnosis of Alzheimers’ disease.”
Michele Colucci Founder & CEO of DigitalDx Ventures said “DigitalDx is honored to have led a successful round for Optina Diagnostics. At DigitalDx we believe the recent technological advances in health data capture enabled by artificial intelligence (AI) could dramatically impact our ability to diagnose illness earlier, potentially and drastically improve patient outcomes and save our healthcare system billions of dollars and could redefine the way we create value in healthcare.”
New funding will support the development of novel Optina’s Retinal Deep Phenotyping platform and also accelerate the clinical trials for early detection of Alzheimer’s to receive the FDA regulatory approval in parallel with therapeutic approvals.
However, the first trial to diagnose Alzheimer’s disease early using the non-invasive high-resolution retinal scan which can detect images amyloid-related retinal changes was carried out by researcher at Cedars-Sinai Medical Center in Los Angeles, California, and NeuroVision Imaging LLC in 2017. The findings of experimental study using autofluorescence retinal scanning strongly suggested that retinal scan can serve as a surrogate biomarker to diagnose Alzheimer’s disease at that time.