FDA Grants Breakthrough Device Designation For StrandDx Hair-Based Test To Aid Autism Diagnosis

The U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation to Linus Biotechnology Inc., for its hair-based StrandDx™-ASD diagnostic aid for autism. The test is intended for use with children birth to 18 months; it uses a single strand of hair to assess the likelihood of autism. It can be used with older children to aid in diagnosis of autism. StrandDx™-ASD is based on novel molecular biomarkers developed using Linus Biotechnology's proprietary exposome and biological response sequencing platform.

The FDA Breakthrough Device designation aims to expedite the review of innovative technologies that provide for . . .