First-Ever Saliva-Based Concussion Test to Be Available in 2023

By LabMedica International staff writers
Posted on 21 Nov 2022

Image: The Clarifi mTBI saliva test collection device (Photo courtesy of Quadrant Biosciences)

According to the (CDC), 1.6 to 3.8 million athletes will experience a sports-related mild traumatic brain injury (mTBI) or concussion each year. Despite increased public awareness, clinical guidelines still rely on subjective symptom scales to diagnose and manage concussions. Furthermore, there are currently no biological tests to diagnose mTBI. Now, new research has revealed that biomarkers found in saliva may distinguish mTBI and parallel symptom recovery.

By analyzing brain derived biomarkers found in saliva, scientists at Quadrant Biosciences (Syracuse, NY, USA), in collaboration with Penn State (Hershey, PA, USA) and the State University of New York (New York, NY, USA), have developed a novel diagnostic test for concussion. These biomarkers can confirm mTBI when run through Quadrant’s proprietary artificial intelligence platform. The Clarifi mTBI Saliva Test being developed by Quadrant uses small non-coding RNAs found in the saliva to help diagnose concussions. The U.S. Patent and Trademark Office (USPTO) has awarded the company and its academic partners with a patent for the analysis and prediction of mTBI and concussion symptoms. Quadrant has started discussions about potentially licensing this technology to third-parties, and the test is expected to be available in late 2023.

"Our motivation for developing this technology was to prevent further harm to the kids, athletes, and adults who experience mild, moderate, or repetitive head impacts," said Dr. Frank Middleton, PhD, Professor at SUNY Upstate Medical University, who led the patented research. "While most of the field has focused on peripheral blood measures, for the past decade we worked extensively to establish the utility of quantifying small RNA molecules in saliva as predictors of concussion or long-lasting symptoms from head impacts."

"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. A saliva-based test for concussion could provide a novel addition to the physician toolbox," said Dr. Steve Hicks, MD, PhD, at Penn State College of Medicine, who was also among the ones to lead the patented research.