A recent SPECTRUM article discussed the FDA’s ‘breakthrough device’ designation for a hair-based diagnostic test for autism. The test is called StranDx, and it was developed by Linus Biotechnology Inc., a provider of precision exposome sequencing. StranDx analyzes the levels of chemicals in a child’s hair for a snapshot of their ‘exposome,’ which includes their environmental exposures and how they regulate certain essential nutrients. This sheds light on how a child’s physiology responds to their environment, which can predict the chances of autism.
FDA Grants ‘Breakthrough Device’ Status to Hair-Based Autism Test
The test analyzes chemical levels in a strand of a child’s hair to predict their chances of having autism.
Jan 21, 2022
Researched List: Blister Machines for Life Sciences
Need a blister machine for life sciences packaging? Our curated list features companies serving pharmaceutical, medical device, nutraceutical, and cosmetic industries. Download to access company names, locations, machine specifications, descriptions, and more.
Download Now
FDA warning letters surge - is your team prepared?
New guide reveals expert strategies to prevent regulatory issues and respond effectively to FDA enforcement actions in pharmaceutical and medical device manufacturing.
Read More