HERSHEY, Pa. — A saliva-based test that rapidly and accurately diagnoses concussions is expected to be available to physicians in 2023 following a patent awarded to Quadrant Biosciences, Penn State, and the State University of New York by the U.S. Patent and Trademark Office. The patent covers an essential component of the team’s Clarifi mTBI Saliva Test, which was developed after several years of research.
According to Steve Hicks, associate professor of pediatrics at Penn State College of Medicine, who co-led the research, 3 million concussions occur in the United States each year and approximately two-thirds take place in children and adolescents.
Concussions — or mild traumatic brain injuries (mTBIs) — occur as a result of physical injury to the head and may result in short-lived symptoms including headaches, dizziness and confusion. Physicians currently use symptom scales and neurocognitive tests to assess patients and diagnose concussions. Hicks said these methods are not always reliable because they can be subject to patient and physician bias. For example, athletes may underreport a symptom’s severity to return to the field.
“Current methods for diagnosing concussions rely on patients to accurately and honestly report their symptoms and participate in neurocognitive testing,” said Hicks. “The Clarifi mTBI Saliva Test — which measures tiny strands of molecules, called micro ribonucleic acids [microRNAs], in saliva following a head trauma — is a non-invasive way to test for concussion that can’t be influenced by a patient’s feelings or motives.”
To develop the test, the team conducted research to determine if the presence of microRNAs in saliva could accurately indicate a concussion. These microRNAs play an important role in cellular processes and exist in high amounts in the brain, Hicks explained.
Indeed, the researchers found that the accuracy of the saliva approach performed favorably when compared with currently available tests involving balance and reaction time. The results were published in the journal Clinical and Translational Medicine.
According to Rich Uhlig, CEO and founder of Quadrant Biosciences, the company is in the process of seeking licensing of this technology and expects the test to be available to physicians in 2023.
“As a pediatrician who provides medical care for children and teens with concussion, I am excited by the potential of this technology to improve the way clinicians manage this common injury,” said Hicks. “A saliva-based test for concussion could provide a novel addition to the physician toolbox.”
Frank Middleton, professor at SUNY Upstate Medical University, also is involved with this research and patent.