The U.S. Food and Drug Administration (FDA) has granted ‘breakthrough device’ designation to a hair-based test designed to aid autism diagnosis. The acknowledgment shifts the test into a fast lane through the agency’s regulatory review process. The test, called StrandDx, analyzes the levels of chemicals in a strand of a child’s hair to capture a snapshot of her ‘exposome’ — some of her cumulative environmental exposures and how she regulates certain essential nutrients. The measures suggest how a person’s physiology responds to her environment, which can predict her chances of having autism, says Manish Arora, Edith J. Baerwald Professor and vice chairman of environmental medicine and public health at the Icahn School of Medicine at Mount Sinai in New York City and co-founder of New York-based Linus Biotechnology, which is developing the test.
