FDA Grants Breakthrough Designation for Diagnostic Help That Identifies Autism Through Hair Strands
The world is constantly looking for new ways to diagnose autism so that the disease can be detected earlier and more action can be taken for people who would benefit from it. Now a new device claims to be able to aid the diagnostic process in a very simple and non-invasive way using the patient’s hair and the FDA wants it to work.
Developed by Linus Biotechnology Inc., the device could be useful as a diagnostic aid for Autism Spectrum Disorders and has just been recognized as a breakthrough device by the FDA.
The company’s invention, the StrandDx ™ ASD device, uses a single strand of hair to determine whether the person is likely to develop autism. It does this by searching for molecular biomarkers developed through a proprietary platform for sequencing exposomes and biological reactions.
The FDA’s pioneering device name is intended to help inventions like the StrandDx ™ ASD device go through the FDA review process faster. This term is often used for devices that are intended to provide better treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions; With the accelerated review process, these technologies get to market faster and get to the people who need them.
“Now, for the first time in medical history, we have the prospect that by examining a single strand of hair, doctors, patients, families and scientists can get the physiological equivalent of a blood test for autism,” said Neil Kurtz, MD, a consultant and director of Linus Biotechnology Inc.
It seems that the device has only seen the beginning of its usefulness so far. Manish Arora, PhD, BDS, MPH, the company’s co-founder and chief scientific officer, says the science behind the new technology could evolve in the future to further improve diagnostic accuracy.
“Molecular biomarkers like StrandDx-ASD are a huge advancement in precision medicine for autism and illustrate the potential for individualized early intervention,” says Arora. “This appointment is an important milestone for Linus Biotechnology Inc. We look forward to working closely with the FDA to prioritize the development of StrandDx-ASD and move it towards commercialization.”
The FDA’s breakthrough label for the device identification indicates that the device is intended for use in newborns up to 21 years of age. It is for use only in babies up to 18 months of age for autism risk assessment and as a diagnostic tool in those over the age of 18 months.
Linus Biotechnology Inc., a leader in precision exposome sequencing with headquarters in New York, hopes to further develop this and other technologies in the future to improve the diagnosis of autism.
