Oculogica’s New Patent Shows Promise for CTE Test

Oculogica, a leader in concussion diagnosis and categorization, with the only U.S. Food and Drug Administration-cleared technology that aids in the diagnosis of concussion without the need for a pre-injury baseline test, has been granted a U.S. patent to protect its method and system for assessing chronic traumatic encephalopathy, the degenerative brain disease known as CTE, in live patients. This is Oculogica’s eighth patent in the United States.
 
CTE describes microscopic findings in the brains of people who have been exposed to repetitive trauma. It has been associated with football and other contact sports, as well as with military combat veterans. CTE currently has only been diagnosed after death, and is identified by the buildup of tau protein in an abnormal location in certain portions of the brain. It has been associated with depression, dementia, moodiness, and even suicide. Researchers have been pursuing additional ways to diagnose CTE because current studies have included biased samples of donated brains, with potentially only the worst cases being donated by families.
 
“There are multiple changes that can happen in the brain after an injury, and CTE is thought potentially to represent a manifestation of some of these changes,” said Oculogica Founder Dr. Uzma Samadani. “In living people, neurons that are not functioning normally are less able to carry and transmit signals. We are using eye tracking to detect these disruptions since so many of the pathways in the brain are implicated in control of eye movement.”
 
The patent is based on early work in 2014 by Dr. Uzma Samadani on subjects with one or more head injuries and a subsequent study she conducted at the University of Minnesota in 2017 on 450 subjects with and without a history of neurotrauma. Subjects were assessed for eye-tracking and a modified version of the Boston Assessment of Traumatic Brain Injury (BATL).
 
“While this patent is important, the work behind it and the additional research to come is even more important,” said Oculogica CEO Dr. Rosina Samadani. “It will require the broader community to solve these tough problems. Multiple organizations have completed very important and valuable research in this area. We believe the next breakthroughs will be achieved through collaboration. We are very interested in that important work and are offering an open invitation to researchers to join us. We are all interested in identifying the changes in the brain that lead to devastating, permanent deficits associated with CTE and other neurotrauma. We are looking forward to engaging in rigorous studies, including a broad population, in which a potentially affected group is compared with a normal study arm, to understand these neurotraumatic effects better, their physiological implications, including dementia and other brain dysfunction, and the patient segments at greatest risk. The work to date has helped highlight this area. We now need to take the next steps together.”
 
To that end, Oculogica is already in discussion with a number of research partners to establish clinical studies, with a goal to develop a version of their concussion diagnostic product, the EyeBOX, that will identify people early who are at risk for the chronic effects of neurotrauma.
 
There has been a growing awareness of the need for objective measures of brain injury. A series of concussive brain injuries to high-profile NHL hockey players this season has increased awareness of the risk for brain injury, including multiple concussions, associated with contact sports. In addition, the NFL recently announced that it was no longer going to use a widely disseminated scoring algorithm for dementia that has been criticized as being biased against Black players, and it has assembled a panel to develop a new testing regime to establish proper norms.
 
“There is a tremendous need for objective measures of both acute and chronic brain injury that are not influenced by race, sex, cultural background, language skills or education,” said Dr. Uzma Samadani. “We are confident that eye tracking will be part of that solution.”
 
Oculogica currently holds seven other patents in the United States. This intellectual property portfolio has enabled them to be the first, and still only, aid in diagnosis of concussion authorized by the U.S. Food and Drug Administration (FDA) that does not require a pre-injury test for a broad range of ages in both pediatrics and adults. The company received its first FDA clearance in December 2018. They also hold patents for measuring elevated intracranial pressure, biometric identification of patients, impairment due to cannabis, and glaucoma detection. This expansion of their patent portfolio contributes to the continued growth of the company and establishment of their technology as a brain dysfunction categorization tool.
 
Oculogica Inc. is an eye tracking-based, neuro-diagnostic company founded by Dr. Uzma Samadani, a neurosurgeon at Centracare and the Minneapolis VA Medical Center, and associate professor of Bioinformatics and Computational Biology at the University of Minnesota School of Engineering. The company has developed the EyeBOX, the first and only FDA cleared baseline-free aid in diagnosis of concussion to help physicians objectively categorize concussion. EyeBOX is a four-minute test for ages 5 to 67. EyeBOX is used by various healthcare organizations, including Midwest Orthopedics at Rush University, the clinics of the President of the California Brain Injury Association, and others.