Linus Biotechnology StrandDx Sequencer Designated a Breakthrough Device

Linus Biotechnology’s StrandDx-ASD diagnostic aid has been designated a Breakthrough Device for autism spectrum disorder (ASD) by the FDA.

Diagnosing ASD can be difficult because there is no FDA-approved molecular biomarker to identify the disorder, the New York City-based company noted.

StrandDx-ASD, which can detect novel molecular biomarkers from a single strand of hair, is intended for patients from birth to age 21 years to assess the likelihood of ASD in children up to 18 months old and to diagnose ASD in patients age 18 months to 21 years.