Healthcare DIVE January 13, 2022
Nick Paul Taylor

FDA has awarded breakthrough designations to several devices and diagnostics for neurological conditions, including an autism test and treatment as well as diagnosis of Parkinson’s disease.

Linus Biotechnology received a breakthrough device designation from FDA for a test to help diagnose autism spectrum disorder (ASD). The experimental test, StrandDx-ASD, is designed to detect molecular biomarkers that Linus developed using its exposome and biological response sequencing platform. Using a strand of hair, the test will assess the likelihood of ASD in children up to 18 months of age, and help with the diagnosis of people aged 18 months to 21 years.

The goal is to accelerate the diagnosis of ASD. Currently, physicians rely on behavioral observations and typically diagnose people around...

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Topics: FDA, Govt Agencies, Medical Devices
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