Relying on a single strand of hair, LinusBio is launching its diagnostic aid for autism spectrum disorder—with a test designed to chart a child’s environmental exposures over time.
The company aims to help physicians rule out the likelihood of autism developing in infants and toddlers under age three, and as young as one month old.
Using research out of Mount Sinai Health System, LinusBio’s ClearStrand-ASD test looks backward in time by following the length of a human hair, similar to reading the lifespan of a tree by counting its rings.
By robotically slicing the hair lengthwise and scanning it with lasers, the company can generate a spectrometric profile of the chemicals a person has been exposed to, including pollutants as well as from their diet, lifestyle and other trace elements—through what LinusBio has described as a “molecular movie” spanning the hair's growth, compared to the singular snapshots of time offered by typical diagnostics.
The prescription test is geared toward children who may have an elevated risk of developing autism, such as those who were born preterm, who have a sibling with autism, or who have already demonstrated characteristics associated with the condition, according to the former Fierce Medtech Fierce 15 winner. ClearStrand-ASD cannot deliver a positive diagnosis, it can only help rule out certain exposures that may make autism more likely.
“With the rise in autism prevalence, earlier diagnosis and intervention in children's formative years have become critical public health priorities,” LinusBio founder and CEO Manish Arora said in a statement.
“Families today often endure exhausting journeys to secure a diagnosis for their child, and this is what we aim to change,” Arora added. “Caregivers now have access to an objective autism biomarker test that, in collaboration with their health care providers, may help them plan the next steps for their child earlier than ever before.”
According to the company, the test can provide a negative predictive value of 92.5%. ClearStrand-ASD has not been reviewed by the FDA; it is offered through LinusBio’s CLIA-certified laboratory, and will be available at launch in 44 states—excluding California, Hawaii, Maryland, New York, Pennsylvania, Rhode Island and the District of Columbia.