by Michelle Diament, Disability Scoop | January 25, 2022
A single strand of hair may be all that’s needed to determine whether a child is likely to have autism.
The Food and Drug Administration has given “breakthrough” status to a device known as StrandDx, which looks for molecular biomarkers in a strand of hair to evaluate how likely it is that a child is on the spectrum.
The designation from the FDA’s Center for Devices and Radiological Health means that the agency has committed to an expedited review of the product and more frequent communication with its developers. The FDA says that it bestows this status for devices that “provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.”
Currently, autism diagnosis is based on an evaluation done by a specialist, but kids can face lengthy waits to see such professionals. Researchers have long sought ways to flag children on the spectrum earlier so that they can access intervention at younger ages when it is most effective.
“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,” said Dr. Neil Kurtz, an advisor and director of Linus Biotechnology, which is behind StrandDx.
The FDA’s breakthrough designation label indicates that StrandDx is intended to be used to assess the likelihood of autism in children from birth to 18 months and to aid in diagnosis of the developmental disability in those ages 18 months to 21 years.
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 that the FDA has approved for autism is one that relies on parents and health care providers to answer questions and submit video of the child.