Optina Diagnostics issued the following announcement on May 8.
Optina Diagnostics announces today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its retinal imaging platform (CAPRS1/MHRC2). Optina Diagnostics' platform uses Artificial Intelligence (AI) to analyze the data rich hyperspectral retinal images captured with the MHRC during a simple eye scan. Optina Diagnostics' platform is intended for the detection of likely positron-emission tomography (PET) amyloid status (negative or positive), to aid in the evaluation of adult patients with cognitive impairment who are being evaluated for Alzheimer's disease and other causes of cognitive decline. Optina Diagnostics' platform is an adjunct to other diagnostic evaluations.
Amyloid PET is the standard method for the detection of amyloid plaques in the brain, a key hallmark of Alzheimer's disease, and may be useful to confirm the diagnosis and optimize the patient management of patients being evaluated of Alzheimer's disease and other causes of cognitive decline. However, amyloid PET is an expensive technique of limited accessibility. In clinical practice, therefore, the diagnosis of Alzheimer's disease is mostly based on clinical symptoms, without evaluation of the amyloid status, which leads to incorrect diagnosis for nearly one third of the patients presenting at the memory clinic with cognitive impairment and half of those presenting with ambiguous cases.
Optina Diagnostics is working towards a non-invasive and more accessible means 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.
"We are excited to receive this Breakthrough Device Designation from the FDA as it recognizes the potential benefits the Optina Diagnostics' platform could bring to clinicians, their patients and families in the diagnosis of Alzheimer's disease and will permit to expedite its development and regulatory approval in the U.S." said David Lapointe, CEO of Optina Diagnostics. "Optina Diagnostics' technology based on data-rich hyperspectral retinal imaging combined with AI opens tremendous possibilities to have insights into the brain non-invasively and at a low cost. 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 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.
Alzheimer's disease is the most common type of dementia, which affects the ability to think, reason and remember clearly, and is the most frequent cause of institutionalization for long-term care. This progressive degenerative brain disease is ultimately fatal, as no disease-modifying treatment currently exits to delay its progression. Nowadays, more than 50 million people are diagnosed with Alzheimer's or a related dementia. It is listed as the sixth-leading cause of death in the United States. The prediction is that by 2050, the number of people suffering from Alzheimer's disease will triple, affecting 14 million people in the US alone, due to aging population demographics. Early detection of this disease is Optina Diagnostics' principal mission.
Original source can be found here.