Newly Available Test Uses Hair To Evaluate Autism Risk
An employee works in LinusBio's laboratory. (Business Wire)
A first-of-its-kind test claims to be able to rule out autism in kids as young as 1 month using a single strand of hair, but not everyone is convinced that the technology is ready for prime time.
LinusBio, a biotech startup, launched the test known as ClearStrand-ASD this month, making it available in 44 states.
The test analyzes a strand of hair using robotics and lasers to look for a molecular signature that’s associated with autism. It is able to rule out the developmental disorder with 92.5% accuracy, the company said.
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If the biomarker is not found, “it is unlikely the child has autism,” LinusBio said. But if it is detected, the company indicates that the child might need additional evaluation from a professional.
The new offering is aimed at children ages 1 to 36 months who are at increased risk for autism, meaning that they were born preterm, have a sibling on the spectrum or have shown characteristics of the developmental disability, according to LinusBio. The test must be ordered by a doctor, but the company will also connect families with a telehealth provider so that they can request a kit from home.
The company notes that ClearStrand-ASD, which costs $2,750, is not meant to be a stand-alone test and doctors should consider the results in context with other factors.
“Families today often endure exhausting journeys to secure a diagnosis for their child, and this is what we aim to change,” said Manish Arora, CEO and founder of LinusBio. “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.”
Despite its promise, however, ClearStrand-ASD has not been approved by the Food and Drug Administration and Andy Shih, chief science officer at Autism Speaks, said he’s not ready to recommend it just yet.
“While the science behind ClearStrand-ASD has the potential to be a valuable resource, more research is needed before the tool can reliably help our families answer questions about autism in its early stages,” Shih said. “Autism Speaks supports evidence-based interventions and tools that have been carefully researched in the detection of autism, and therefore, plans to research collaborations to facilitate additional studies around ClearStrand-ASD technology and to increase access by members of our community.”
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