CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
September 2021—Quadrant Biosciences has been granted a breakthrough device designation for its Clarifi ASD autism saliva test by the FDA’s Center of Devices and Radiological Health.
Clarifi ASD is indicated for use in assessing the likelihood that a child has autism spectrum disorder based on an evaluation of RNA epigenetic biomarkers in the saliva sample, as well as key patient characteristics. The test is available to children 18 months through six years old. It is for prescription use only and must be ordered and administered by a health care provider.
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