It’s common knowledge that most treatments work best when they are started as soon as possible. Whether it’s a physical injury like a broken arm, an emotional disturbance like depression, or a neurological divergence like autism (Autism Spectrum Disorder or ASD), early identification and treatment is key to achieving the best possible outcomes.
ASD Can Be Difficult to Diagnose
However, some conditions are difficult to diagnose because of the nature of their symptoms, and thus tend to be diagnosed after some time. ASD has traditionally been diagnosed only through extensive behavioral observations and review of input from family members and others involved in the child’s life. There has never been a definitive biological test to detect biomarkers for possible autism, so most children do not get evaluated for the condition until they are around age 4, and may not receive a formal diagnosis until many years later. Precious time that could be spent on therapy to improve the child’s quality of life, like ABA, is instead wasted waiting for appointments.
A DNA-based ASD Diagnostic Tool
StrandDx™-ASD, developed by Linus Biotechnology Inc. in New York, aims to change that with the first ever DNA-based autism diagnostic tool. With just one strand of the child’s hair, StrandDx™-ASD claims to be able to reliably detect biological markers that indicate possible ASD. For children from birth to 18 months, the test predicts the likelihood of developing an ASD, while for children 18 months through 21 years, the test can actually aid in diagnosis.
Being able to determine which children are genetically predisposed to ASD at birth is monumental for early diagnosis and intervention. Imagine the difference starting therapy as an infant could make for children with an ASD!
FDA Breakthrough Device Designation
In early December 2021, the FDA granted StrandDx™-ASD the designation of “Breakthrough Device” for ASD. But what does that mean?
To receive the FDA’s “breakthrough” designation, a device must provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases and conditions. StrandDx™-ASD has met this requirement in the eyes of FDA researchers and will now be fast-tracked through their regulatory review process.
Next Steps
Now that Linus Biotechnology has the green light to move forward with StrandDx™-ASD, they plan to conduct a study involving 5,000 children, comparing StrandDx™-ASD to traditional, gold-standard diagnostic methods for ASD. The FDA and Linus will use the results of this study to guide their next moves with this revolutionary device.
The Future of ASD Diagnosis?
While the opportunity that StrandDx™-ASD presents sounds incredible, it’s important to note that much more research is needed to determine if it can reliably predict and/or diagnose an ASD in a large sample of children. Many experts remain skeptical of Linus’ claims about StrandDx™-ASD and note that Linus has not made any of the data they say validates their claims available for public review. However, Linus says they have provided this data to the FDA. Whether StrandDx™-ASD becomes the future of ASD diagnosis is still up in the air, but we will be closely monitoring the device’s progression through the FDA pipeline in the months to come.
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