FDA Fast-Tracks device to assess autism risk using hair

A company hopes to analyze hair to help identify children with autism. (Rachel Coyne/Unsplash)

A single strand of hair can be enough to determine if a child is likely to have autism.

The Food and Drug Administration has granted “breakthrough” status to a device known as the StrandDx, which looks for molecular biomarkers in a strand of hair to gauge a child’s likelihood of being on the spectrum.

The FDA’s Center for Devices and Radiological Health designation means the agency is committed to expedited review of the product and more frequent communication with its developers. The FDA says it grants this status to devices that “provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.”

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Currently, the diagnosis of autism is based on an assessment by a specialist, but children may face long waits to see such professionals. Researchers have long looked for ways to flag children on the spectrum earlier so they can access intervention at a younger age, when it is most effective.

“Now, for the first time in the history of medicine, we have the prospect that by studying a single hair, doctors, patients, families and scientists can obtain the physiological equivalent of a blood test for autism,” said Dr. Neil Kurtz. , advisor and director of Linus Biotechnology, which is behind StrandDx.

The FDA’s breakthrough designation label indicates that StrandDx is intended for use in assessing the likelihood of autism in children from birth to 18 months of age and to aid in the diagnosis of intellectual disability in persons 18 months of age. 21 years old.

The technology behind StrandDx was developed by researchers at the Icahn School of Medicine at Mount Sinai in New York, the company said.

In recent years, other companies have worked to bring autism diagnostic aids to market that rely on saliva and blood. To date, however, the only diagnostic aid the FDA has approved for autism is one that relies on parents and healthcare providers to answer questions and submit a video of the child.