FDA Breakthrough Device Designation Given to Product Using Hair to Diagnose ASD

January 31, 2022

StrandDx Analyzes the Levels of Chemicals in a Strand of Hair

Decades into America’s surge of autism cases, diagnosing the neurodevelopmental disorder still relies on behavioral observations made by an experienced professional. This diagnostic process can take several months to complete.  Currently, the average age of autism diagnosis is approximately 4 years old. However, that may all change due to a new product called StrandDx by Linus Biotechnology Inc. According to the co-founder and Chief Scientific Officer of the company, Manish Arora, the product analyzes the levels of chemicals in a strand of a child’s hair to determine a temporal sequence of their “exposome.” The exposome shows the child’s cumulative environmental exposures and how they regulate certain essential nutrients. Arora states, “The measure suggests how a person’s physiology responds to their environment, which can predict their chances of having autism.” The intended use of StrandDx will extend to patients from birth to 21 years. The test will assess the “likelihood of ASD” in children from birth to 18 months old, and will aid in diagnosis of ASD in patients aged 18 months to 21 years. Arora and the company’s other co-founders believe their product is a major step forward in precision medicine for autism and feel it could be a major improvement for deploying individualized early intervention.  


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