FDA designates sequencing aid as “breakthrough device”

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Linus Biotechnology Inc., a leader in precision exposome sequencing, 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 (ASD).

The FDA Breakthrough Device designation aims to expedite the review of innovative technologies that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions

StrandDx™-ASD is based on novel molecular biomarkers developed using Linus Biotechnology's proprietary exposome and biological response sequencing platform, utilizing a single strand of hair. According to the Breakthrough Device designation label, the intended use of StrandDx™-ASD will extend to patients from birth to 21 years, where the test will assess the likelihood of ASD in children from birth to 18 months old, and aid in diagnosis of ASD in patients aged 18 months to 21 years.

The Precision Exposome Sequencing Platform described is based on technology developed by Dr. Manish Arora and other faculty members at the Icahn School of Medicine at Mount Sinai and licensed to Linus Biotechnology Inc. Mount Sinai and Mount Sinai researchers, including Manish Arora, have a financial interest in Linus Biotechnology Inc.