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FDA Grants ‘Breakthrough Device’ Status to Hair-Based Autism Test

The test analyzes chemical levels in a strand of a child’s hair to predict their chances of having autism.

A recent SPECTRUM article discussed the FDA’s ‘breakthrough device’ designation for a hair-based diagnostic test for autism. The test is called StranDx, and it was developed by Linus Biotechnology Inc., a provider of precision exposome sequencing. StranDx analyzes the levels of chemicals in a child’s hair for a snapshot of their ‘exposome,’ which includes their environmental exposures and how they regulate certain essential nutrients. This sheds light on how a child’s physiology responds to their environment, which can predict the chances of autism.

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