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University/industry consortium secures patent for Autism Spectrum Disorder diagnostic test

Quadrant Biosciences Inc., SUNY Research Foundation and Penn State Research Foundation announced that the U.S. Patent and Trademark Office has issued a new patent, No. 11,242,563 - Analysis of Autism Spectrum Disorder. The new patent strengthens the intellectual property position and coverage for the Syracuse, NY-based life science company’s Clarifi Dx™ Molecular Diagnostic Platform. 

Clarifi ASDⓇ, the first-ever epigenetic test for autism spectrum disorder (ASD), is designed to aid the diagnosis of autism in children 18 months through six years of age. Quadrant Biosciences, which is housed at the CNY Biotech Accelerator, collaborated with researchers Frank Middleton, PhD, from Upstate Medical University and Steve Hicks, MD, from Penn State College of Medicine to create this groundbreaking biological test that is based on regulatory RNAs and microbes in the saliva. 

Approximately 1 in 44 American children are currently diagnosed with ASD, a 10-fold increase in prevalence over the past 40 years. Unfortunately, this high rate of autism in the US, when combined with a relatively small number of specialists trained to make the diagnosis, has resulted in long waiting times for families to receive an autism evaluation. Consequently, while diagnosis is possible in children as young as 18 months, the average age of ASD diagnosis in the United States today exceeds 4 years of age. Early diagnosis is important because intensive behavioral therapy has been shown to improve the symptoms of autism, and children benefit more from such intervention the earlier it is started. 

Clarifi ASD is the result of seven years of research at Upstate and Penn State College of Medicine that has been funded by the National Institute of Mental Health and the American Academy of Pediatrics, among others. Numerous peer-reviewed research papers have been published supporting the science.  

The test itself is a prescription only, laboratory-developed test that must be ordered by a healthcare provider. 

About Quadrant Biosciences

Quadrant Biosciences is a life science company developing molecular diagnostic solutions for large-scale health issues. Revolutionary advancements in the early detection of autism spectrum disorder, Parkinson’s disease, and mTBI, through the application of the Clarifi Dx molecular diagnostic platform, could have a significant impact on the way clinicians approach the diagnosis and treatment of these serious conditions. 

About the SUNY Research Foundation

The SUNY Research Foundation (RF) is the largest comprehensive university-connected research foundation in the country. It provides essential administrative services that enable State University of New York (SUNY) faculty to focus their efforts on educating students and performing life-changing research across a wide range of disciplines including Artificial Intelligence, Clean Energy, Biotechnology, Longevity, Substance Addiction, Nextgen Quantum Computing, Environmental Health, and Resiliency. The RF works with the academic and business leadership of SUNY campuses to facilitate research and discovery by administering sponsored projects and delivering intellectual property and technology transfer services that fuel innovation and move ideas and inventions to the marketplace. The RF is a private non-profit education corporation that is tax-exempt under Internal Revenue Code (IRC) Section 501(c) (3). To learn more about the RF, visit

About the Penn State Research Foundation

The Penn State Research Foundation traces its origins to 1934, when the Penn State Research Corporation was formed “for the purpose of fostering and advancing scientific research” which included the creating, purchasing, holding, and licensing of rights for inventions, designs, and other intellectual property. 

Today, Penn State consistently ranks among the nation’s top 25 public research universities, with annual research expenditures regularly hovering around $1 billion. The Penn State Research Foundation continues to support the Penn State research enterprise and -- consistent with the land-grant mission -- enhances the impact of Penn State research to drive economic development across the Commonwealth and beyond. 

Tags Tags: Upstate Medical University , Research , Innovation

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