SYRACUSE, N.Y., April 19, 2021 /PRNewswire/ — Quadrant Biosciences Inc., a developer of novel molecular diagnostic tools, has been granted a Breakthrough Device designation by the Center of Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) for its innovative Clarifi ASD® autism saliva test.
Clarifi ASD is indicated for use in assessing the likelihood that a child has autism spectrum disorder (ASD) based on an evaluation of RNA epigenetic biomarkers in the saliva sample, as well as key patient characteristics. This novel test has the potential to substantially increase the efficiency of ASD identification, and lead to more rapid referral for early intervention services.
The FDA Breakthrough Device Program is intended to help patients and health care providers receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions.
«We are thrilled to have received this important designation, and look forward to working collaboratively with the FDA to quickly advance this much needed technology,» said Richard Uhlig, Founder and CEO of Quadrant Biosciences. «This represents a major milestone for Quadrant and will ultimately help millions of children and families get appropriate treatment faster.»
Quadrant Biosciences is a life science company developing molecular diagnostic solutions for large-scale health issues. The company has entered into collaborative research relationships with a number of institutions including SUNY Upstate Medical University and Penn State University to explore and develop novel biomarker technologies with a focus on Autism Spectrum Disorder, concussion, and Parkinson’s disease. Recently, it has leveraged its expertise in RNA analysis to address the Covid-19 pandemic. Quadrant participates in the Start-up NY program, a New York State economic development program. For more information about Quadrant, please visit www.quadrantbiosciences.com.
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SOURCE Quadrant Biosciences Inc.