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Novel epigenetic saliva test for autism developed in part at Upstate receives patent

A novel epigenetic saliva test for autism developed through groundbreaking research by Upstate Medical University, Quadrant Biosciences and Penn State College of Medicine has been awarded a patent.

The United States Patent and Trademark Office (USPTO) has issued the patent to Quadrant Biosciences its partners, the SUNY Research Foundation and Penn State Research Foundation. The patent covers the scientific foundation for the development of a saliva-based, multiomic autism diagnostic aid, that can differentiate individuals with autism from individuals with typical development or developmental delays by measuring microRNA (miRNA) and microbiome levels in saliva.

Quadrant Biosciences, a Life Science company based in the Central New York Biotech Accelerator in Syracuse, leverages next-generation sequencing and AI to develop RNA-based molecular diagnostics for a range of medical conditions.

"The issuing of an official U.S. patent for our work on the development of a saliva-based diagnostic aid for autism is a clear acknowledgment of the novelty and utility of the approach that we developed," said Upstate Professor Frank Middleton, PhD, one of the principal investigators behind the patented research. "Our focus on deploying a multiomic approach that combines regulatory RNA features from the human host as well as the oral microbiome has yielded considerable insight into autism spectrum disorder."

Steve Hicks, MD, PhD of Penn State College of Medicine, the other key inventor on the patent, explained its potential clinical significance. "We hope this molecular tool will enhance the ability of clinicians to distinguish children on the autism spectrum from peers with non-autistic developmental delay, enabling earlier diagnoses and earlier initiation of behavioral therapy. Moreover," he continued, "this milestone validates the inherent innovation in Quadrant Biosciences' research and advances our collective goal of improving medical care for children with autism spectrum disorder."

"We are delighted that the USPTO has granted our patent for this groundbreaking work," said Rich Uhlig, founder and CEO of Quadrant Biosciences. "This supports our years of rigorous R&D efforts to illuminate the epigenetic factors associated with autism, and develop novel diagnostic biomarkers to address the urgent need to shorten the protracted autism diagnostic odyssey for parents and caregivers."