New hair strand test for Autism sparks hope and debate
Pranjal Chandra | THE TIMES OF INDIA NEWS SERVICE | Feb 06, 2025, 22:31 IST
( Image credit : TIL Creatives )
A new test called Clearstrand-ASD, developed by LinusBio, can potentially speed up autism diagnostics in children by ruling out the disorder using a single hair strand. Despite promising results, the test is yet to be FDA-approved and lacks extensive validation. Available in 44 states for $2,750, it aims to reduce wait times for autism evaluations.
A new test designed to help rule out autism in young children is generating both excitement and skepticism within the medical community. The test, developed by LinusBio, a New Jersey-based startup, analyzes metabolic biomarkers from a single strand of hair. While some experts see promise in the method, others urge caution, citing the need for further research before it becomes a widely accepted tool in autism diagnostics.
A potential breakthrough in early Autism detection
Autism spectrum disorder (ASD) is typically diagnosed through behavioral evaluations, language assessments, and neurological examinations, a process that can take years due to the shortage of specialists. LinusBio’s new test, Clearstrand-ASD, aims to speed up this process by ruling out autism in children between 1 and 36 months old. Unlike traditional diagnostic methods, the test does not confirm autism but helps physicians determine which children are unlikely to have the disorder, allowing resources to be allocated to those most in need of intervention.
Dr. Manish Arora, LinusBio’s co-founder and CEO, emphasizes that early intervention is crucial in improving outcomes for children with autism. "The earlier you intervene, the better off children are," Arora stated. He hopes that by eliminating uncertainty for some families, the test can reduce long wait times for autism evaluations and direct services more efficiently.
How the test works
Clearstrand-ASD analyzes a child’s metabolic history by examining the substances they have processed over time. A strand of hair, just one centimeter in length, provides a record of metal exposure and other biochemical markers that some research suggests could be linked to autism. The test uses laser technology to convert the hair into plasma, which is then examined using machine-learning algorithms.
LinusBio claims that in a study of 490 children in California, the test was able to rule out autism with 92.5% accuracy. However, these results have not yet been published in a peer-reviewed journal, leading some scientists to caution against widespread adoption of the test at this stage.
Regulatory and cost challenges
Despite the enthusiasm around Clearstrand-ASD, the test has not been approved by the Food and Drug Administration (FDA). Nevertheless, it is now available in 44 states at a cost of $2,750, with no insurance coverage currently available. Parents can order the test through a primary care provider or directly from LinusBio, which arranges a telehealth consultation to interpret the results.
Dr. Stephen Sheinkopf of the University of Missouri’s Thompson Center for Autism and Neurodevelopment believes the test shows promise but stresses the need for additional validation. "This seems like an approach that has the potential to be part of a suite of ways we can screen children, but it needs more evidence," he said.
A step forward or a work in progress?
While some experts believe Clearstrand-ASD could help alleviate the backlog in autism diagnoses, others caution against relying on it too soon. The American Academy of Pediatrics recommends standard screenings at 18 and 24 months, and many argue that well-established diagnostic pathways should remain the primary method.
As research continues, Clearstrand-ASD represents both an exciting advancement and a topic of debate in the world of autism diagnostics.
A potential breakthrough in early Autism detection
Autism spectrum disorder (ASD) is typically diagnosed through behavioral evaluations, language assessments, and neurological examinations, a process that can take years due to the shortage of specialists. LinusBio’s new test, Clearstrand-ASD, aims to speed up this process by ruling out autism in children between 1 and 36 months old. Unlike traditional diagnostic methods, the test does not confirm autism but helps physicians determine which children are unlikely to have the disorder, allowing resources to be allocated to those most in need of intervention.
Dr. Manish Arora, LinusBio’s co-founder and CEO, emphasizes that early intervention is crucial in improving outcomes for children with autism. "The earlier you intervene, the better off children are," Arora stated. He hopes that by eliminating uncertainty for some families, the test can reduce long wait times for autism evaluations and direct services more efficiently.
How the test works
Clearstrand-ASD analyzes a child’s metabolic history by examining the substances they have processed over time. A strand of hair, just one centimeter in length, provides a record of metal exposure and other biochemical markers that some research suggests could be linked to autism. The test uses laser technology to convert the hair into plasma, which is then examined using machine-learning algorithms.
LinusBio claims that in a study of 490 children in California, the test was able to rule out autism with 92.5% accuracy. However, these results have not yet been published in a peer-reviewed journal, leading some scientists to caution against widespread adoption of the test at this stage.
Regulatory and cost challenges
Despite the enthusiasm around Clearstrand-ASD, the test has not been approved by the Food and Drug Administration (FDA). Nevertheless, it is now available in 44 states at a cost of $2,750, with no insurance coverage currently available. Parents can order the test through a primary care provider or directly from LinusBio, which arranges a telehealth consultation to interpret the results.
Dr. Stephen Sheinkopf of the University of Missouri’s Thompson Center for Autism and Neurodevelopment believes the test shows promise but stresses the need for additional validation. "This seems like an approach that has the potential to be part of a suite of ways we can screen children, but it needs more evidence," he said.
A step forward or a work in progress?
While some experts believe Clearstrand-ASD could help alleviate the backlog in autism diagnoses, others caution against relying on it too soon. The American Academy of Pediatrics recommends standard screenings at 18 and 24 months, and many argue that well-established diagnostic pathways should remain the primary method.
As research continues, Clearstrand-ASD represents both an exciting advancement and a topic of debate in the world of autism diagnostics.