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FDA Fast-Tracks Device To Assess Autism Risk Using Hair

[Source:  Almooon, photo credit: Rachel Coyne/Unsplash]

A company hopes to analyze her to help identify children with autism.

A single lock of hair may be all it takes to determine whether a child likely has autism.

The Food and Drug Administration has granted “breakthrough” status to a device known as StrandDx, which looks for molecular biomarkers in a strand of hair to assess how likely a child is to be on the spectrum.

The designation from the FDA’s Center for Devices and Radiological Health means the agency is committed to accelerated product review and more frequent communication with 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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