FDA grants breakthrough designation to device that may assess autism risk via hair strand

The FDA has granted breakthrough device designation to Linus Biotechnology Inc. for a diagnostic aid that may identify the presence of autism spectrum disorder using a single strand of hair.

The company’s StrandDx-ASD device uses novel molecular biomarkers developed using a proprietary exposome and biological response sequencing platform. The breakthrough device designation label noted the intended use of the platform will be applicable to patients between birth and age 21 years, with risk assessment for ASD to be conducted between birth and 18 months and diagnostic aid occurring between age 18 months and 21 years.

"Now for the first time in the history of medicine we have the prospect that, by studying a single strand of hair, physicians, patients, families and scientists can get the physiological equivalent of a blood test for autism," Neil Kurtz, MD, an adviser and director of Linus Biotechnology Inc., said in a press release.

Manish Arora, PhD, BDS, MPH, co-founder and chief scientific officer of the company, underscored the potential benefits of further development of this diagnostic aid.

“Molecular biomarkers, like StrandDx-ASD, are a major step forward in precision medicine for autism and illustrate the potential to deploy individualized early intervention," Arora said. "This designation is a major milestone for Linus Biotechnology Inc. We look forward to working closely with the FDA to prioritize development of StrandDx-ASD and moving it forward toward commercialization.”