First-of-its-Kind Diagnostic Aid Uses a Single Hair Strand to Detect Autism Risk in Babies

New Jersey-based Linus Biotechnology Inc. (LinusBio), a precision medicine startup, just launched ClearStrand-ASD, a novel biomarker test for autism spectrum disorder (ASD). This first-of-its-kind diagnostic aid analyzes a single strand of hair to detect a molecular signature linked to autism. It helps doctors rule out ASD in children aged 1 to 36 months when autism is a concern. It does not provide a diagnosis, but does serve as a diagnostic aid with a 92.5% negative predictive value (NPV), identifying children unlikely to be on the spectrum. Results may help inform decisions to refer a child for early intervention and for diagnostic evaluation by an autism specialist.

For Children at Higher Autism Risk: Preterm Birth, Family History, or Early Signs

A new test is changing how doctors screen for autism in young children. ClearStrand-ASD, developed by U.S.-based LinusBio, helps healthcare providers rule out autism spectrum disorder (ASD) in children aged 1 to 36 months. Unlike genetic tests, it analyzes a single strand of hair to track how a child’s body responds to environmental exposures over time. Using a specialized algorithm, the test assesses autism risk—but it does not provide a diagnosis. A licensed healthcare provider must order it. 

Diagnosing autism can be a long and uncertain process, often relying on behavioral observations that delay diagnosis until age four. ClearStrand-ASD offers a new biochemical approach by analyzing metabolic patterns, helping to identify children who are unlikely to be on the spectrum at an earlier stage.

“This is challenging, as early intervention—particularly between one and three years—has been shown to improve language and social communication skills significantly,” said Thomas Frazier, PhD, Professor of Psychology at John Carroll University. With one in 36 U.S. children diagnosed with autism, early identification remains critical.

ClearStrand-ASD Results: Negative or Non-Negative for Autism Likelihood

ClearStrand-ASD gives two possible results: negative or non-negative. A negative result means the child is unlikely to have autism. A non-negative result doesn’t confirm autism but suggests further evaluation may be needed. The test is not a standalone diagnostic tool, and thus doctors should consider it alongside other clinical factors. LinusBio performs the test in its certified laboratory (CLIA #31d2307499), though it has not been cleared or approved by the U.S. FDA.

The test is designed for infants and toddlers at higher risk of autism, including those born preterm, with an autistic sibling, or showing early signs of ASD. Parents can request it from home through an independent telehealth provider, but a doctor must approve it. If the test does not detect the biomarker, autism is unlikely. If it does, further evaluation by a specialist may be needed. 

How It Works: AI, Lasers, and Metabolic Markers

ClearStrand-ASD uses laser ablation-inductively coupled plasma-mass spectrometry (LA-ICP-MS) to analyze a child’s metabolic history. The process involves using lasers to turn a hair strand into plasma, which is then processed by machine-learning algorithms. The test examines how the body metabolizes elements like mercury, lead, cadmium, and arsenic—substances linked to autism risk. “This biomarker is a set of molecular patterns that indicate a child’s biological response to certain essential and non-essential elements,” LinusBio explains.

Manish Arora, co-founder and CEO of LinusBio, said ClearStrand-ASD is the only biochemical test available to detect autism spectrum disorder (ASD) in children younger than 18 months. He hopes it will make the process of ruling out autism more efficient and reduce wait times for those most in need of intervention or treatment.

“The focus is really on early intervention,” Arora said. “The earlier you intervene, the better off children are.”

The test analyzes a child’s hair to assess metabolic history, revealing exposure patterns and substance processing over time. Arora emphasized that the test reveals how environmental exposures interact with biology, a key factor in autism’s complexity. Of his research, published in Nature, suggests disrupted metal absorption and metabolism during development may contribute to ASD risk. His findings show children with autism absorb less manganese and zinc, essential for brain development, and more neurotoxic lead. ClearStrand-ASD does not replace clinical diagnosis but offers a data-driven tool for early screening. It helps doctors identify children needing further evaluation.

Interpreting the Results: What Parents and Doctors Need to Know

Families receive either a Negative or Non-negative result. A Negative result means a 92.5% probability the child is not autistic. A Non-negative result does not confirm autism but indicates the need for further evaluation by a specialist. LinusBio states the test provides results in about three weeks, offering an earlier risk assessment than current methods. ClearStrand-ASD detects metabolic patterns early, helping identify at-risk children and enabling timely intervention. Arora tested the system on 490 high-risk children in California and found it was 92.5% accurate. These results have not yet been published in a peer-reviewed journal.

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Author

Bernice Lottering