News Report | February 16, 2022
FDA Grants ‘Breakthrough Device’ Designation To Linus Biotechnology For Hair-Based Test To Aid Autism Diagnosis
On December 7, 2021, Linus Biotechnology Inc. announced it had received “Breakthrough Device” status from the U.S. Food and Drug Administration (FDA) for its hair-based StrandDx™ test to aid in autism diagnosis. StrandDx analyzes the levels of chemicals in a strand of hair to capture a snapshot of the person’s cumulative environmental exposures and how certain essential nutrients are regulated. The analysis suggests how a person’s physiology responds to the environment, which can predict the chances of having autism.
StrandDx is intended for use with children birth to 18 months. However, it can be used with . . .