Posted by Michael Wonder on 07 Dec 2021
Linus Biotechnology receives FDA breakthrough device designation for StrandDx-ASD exposome sequencing diagnostic
7 December 2021 - Linus Biotechnology today announced that the U.S. Food and Drug Administration Center for Devices and Radiological Health has granted the Company's StrandDx-ASD diagnostic aid the designation as a breakthrough device for autism spectrum disorder.
StrandDx-ASD is based on novel molecular biomarkers developed using Linus Biotechnology's proprietary exposome and biological response sequencing platform, utilising a single strand of hair.
