Quadrant Biosciences, Syracuse, NY, has been granted a Breakthrough Device designation by the Center of Devices and Radiological Health (CDRH) of the FDA for its 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 healthcare 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,” says 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.”
For more information, visit Quadrant Biosciences.