Quadrant Biosciences Receives Breakthrough Device Designation for Novel Autism Saliva Test

Quadrant Biosciences Receives Breakthrough Device Designation for Novel Autism Saliva Test
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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.

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