The world is constantly looking for new ways to diagnose autism so that the condition can be caught earlier and more intervention can be given to individuals who would benefit from it. Now a new device claims to be able to aid in the diagnostic process in a very simple and non-invasive way, using the patient’s hair, and the FDA wants to see it work its magic.
The device, created by Linus Biotechnology Inc., might be useful as a diagnostic aid for autism spectrum disorder, and it has just been granted breakthrough device designation by the FDA.
The company’s invention, the StrandDx™-ASD device, uses a single strand of hair to determine whether autism is likely to present in the individual. It does this by looking for molecular biomarkers developed through a proprietary exposome and biological response sequencing platform.
The FDA’s breakthrough device designation is meant to help inventions like the StrandDx™-ASD device make it through the FDA review process more quickly. This designation is often given to devices that are meant to provide better treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions; the expedited review process means that these technologies get on the market and out to the people who need them faster.
“Now for the first time in the history of medicine, we have the prospect that, by studying a single strand of hair, physicians, patients, families, and scientists can get the physiological equivalent of a blood test for autism,” says Neil Kurtz, MD, an adviser and director of Linus Biotechnology Inc.
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It appears the device has only lived out the very beginning of its usefulness so far. Manish Arora, PhD, BDS, MPH, co-founder and chief scientific officer of the company, says the science behind the new technology could be developed further in the future in order to continue to improve diagnosis accuracy.
“Molecular biomarkers, like StrandDx-ASD, are a major step forward in precision medicine for autism and illustrate the potential to deploy individualized early intervention,” Arora says. “This designation is a major milestone for Linus Biotechnology Inc. We look forward to working closely with the FDA to prioritize development of StrandDx-ASD and moving it forward toward commercialization.”
The FDA’s breakthrough device designation label noted that the intended use of the device is for newborns up through age 21. It is to be used for autism risk assessment only in babies up to 18 months of age and as a diagnostic aid in people over the age of 18 months.
Linus Biotechnology Inc., a leader in precision exposome sequencing headquartered in New York, hopes to continue developing this and other technologies to improve autism diagnosis in the future.
Source: The Autism Site Blog
