Eye-tracking test for Parkinson’s given FDA Breakthrough Device status
The US Food and Drug Administration (FDA) has delivered a Breakthrough Device Designation to a novel eye-tracking technology that claims to offer objective and early diagnosis of Parkinson’s disease. The FDA designation is hoped to accelerate the approval process for the test offering clinicians a new and reliable way to diagnose the degenerative disease at its earliest stage.
"In my experience Parkinson's patients often struggle for years, going from doctor to doctor trying to get a correct diagnosis,” explains George Gitchel, a researcher who has worked on the link between eye tremors and Parkinson’s disease for many years. "When assessing Parkinson's disease, 60% of patients are misdiagnosed at least once, with one third of patients misdiagnosed twice. That is a terrifying and unacceptable statistic in the age of modern medicine.”
A great deal of ongoing research has been focusing on biomarkers in the eye as early signs of Parkinson’s disease. Some studies are suggesting a link between a thinning of the retina and the onset of Parkinson’s, pointing to a non-invasive eye test as a way of catching the disease before other neurodegenerative symptoms appear.
This new test, developed by health technology company RightEye, is based on research suggesting small ocular tremors can be detectable before other symptoms surface. RightEye’s novel eye-tracking technology has been in clinical use for several years helping doctors identify a variety of vision disorders.
This new FDA Breakthrough Device Designation focuses on the RightEye technology being used to assist doctors in diagnosing Parkinson’s disease. The Breakthrough Device program is similar to the FDA’s Breakthrough Therapy program. It is designed to expedite the development, assessment and review of medical devices that demonstrate evidence of being more effective in treating or diagnosing serious illness, compared to current devices on the market.
The designation is a clear sign that the research into eye-tracking as a diagnostic model for Parkinson’s is promising and effective. While the RightEye Vision System is already currently available for clinicians to use, it will take more research before the technology can be widely deployed for Parkinson’s disease diagnostics.
Adam Gross, RightEye’s CEO, suggests the valuable FDA designation should help bring this vital tool to market offering doctors a new, objective measurement to help catch this degenerative disease at its earliest stage.
"With this FDA Breakthrough Device Designation, RightEye has an opportunity to address a critical unmet need in the fight against Parkinson's Disease," says Gross. "The annual cost of Parkinson's disease in America is estimated at approximately $52 billion. Earlier assessment, intervention, and more accurate diagnoses is anticipated to reduce these costs, while also improving patient outcomes and quality of life."