The U.S. Patent and Trademark Office (USPTO) has awarded Quadrant Biosciences and two of its academic partners, the State University of New York Research Foundation and the Penn State Research Foundation, with U.S. Patent No.11,453,914 for the analysis and prediction of mild traumatic brain injury (mTBI) and concussion symptoms.

This patent is a transformative piece of intellectual property that Quadrant is using to develop its Clarifi mTBI Saliva Test, expected to be available in late 2023. Quadrant has started discussions about potentially licensing this technology to third-parties. This test uses small non-coding RNAs found in the saliva to help diagnose concussions.

“My son sustained a serious concussion in a youth hockey game. That’s when I discovered there needed to be a better, more exact way to diagnose concussions. I started Quadrant Biosciences in 2015 in Syracuse, NY on the foundation of improving the lives of children and families,” says Rich Uhlig, CEO and founder of Quadrant Biosciences. “Seeing this patent come through is a realization of goals set 7 years ago.”

The patented research was led by Frank Middleton, PhD, professor at SUNY Upstate Medical University, and Steve Hicks, MD, PhD, now at Penn State College of Medicine, and focused on young adult and pediatric populations, who are most at risk for head injuries.  

“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,” says Middleton. “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.”

The research that led to the patent was first mentioned on CNN back in 2017.

“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,” Hicks says. “A saliva-based test for concussion could provide a novel addition to the physician toolbox.”

This is the second patent awarded in less than one year to Quadrant and its partners. In March 2022, a patent was issued from the USPTO for its development of a saliva-based, epigenetic autism diagnostic aid; this same technology received FDA Breakthrough Device designation in April 2021.

The company says it will continue to leverage its novel use of next-generation sequencing technology combined with advanced bioinformatics and machine learning techniques to develop and validate new diagnostics for other neurological conditions. Quadrant, as well as a National Institutes of Health grant, are funding the development of these commercial tests.