LinusBio
March 19, 2026
Expansion backed by a new global validation study of more than 1,600 participants, reinforcing the test's accuracy across a broader age range
NORTH BRUNSWICK, N.J.LinusBio, a leader in exposomic sequencing and precision health, today announced that ClearStrand™ASD, its first-of-its-kind biochemical test designed to help rule out autism spectrum disorder (ASD), is now available for children up to age 10. This broadens the test’s previously validated use beyond children under 48 months, making it the only objective autism rule-out test that spans from infancy through childhood. The expansion is supported by data from a global study of 1,697 participants, which has been submitted for publication in a peer-reviewed journal.
ClearStrand-ASD is the first and only biochemical screening test for autism spectrum disorder, intended to help health care providers rule out autism when it is a concern. Available by prescription in 49 states, the noninvasive test requires only a strand of hair and can be used in children as young as one month of age. The test is performed in LinusBio's CLIA-certified laboratory, where proprietary robotics and lasers analyze hundreds of data points along the hair strand to identify biological, metabolic, and molecular patterns associated with ASD. With 90% sensitivity and a 95% negative predictive value, ClearStrand-ASD is highly accurate in ruling out autism, supporting earlier clinical decision-making and timely access to intervention.
Autism spectrum disorder affects a growing number of children worldwide. In the United States, about 1 in 31 children aged 8 years has been identified with ASD, according to estimates from the Centers for Disease Control, and globally, the World Health Organization estimates that about 1 in 127 people are on the autism spectrum. As awareness grows, so does interest in objective tools that can complement behavioral and developmental evaluations and support earlier clinical decision-making.
“From the beginning, our goal has been to support families and healthcare providers by providing them with a screening tool that keeps improving as the science advances,” said Manish Arora, Ph.D., founder and CEO of LinusBio. “As we generate more data and deepen our understanding of the biology, we can expand the test to help a broader group of families and clinicians. Extending access from early childhood to children up to age 10 is an important step toward reaching more families who may benefit from earlier biological insight.”
ClearStrand-ASD represents the first clinical application of LinusBio’s broader exposomic sequencing platform, which is designed to reveal how environmental exposures interact with human biology over time. In expanding the test’s validated age range, LinusBio aims to extend the reach of this platform-driven approach and provide more families with earlier biological insight during the developmental evaluation process.
About ClearStrand-ASD
ClearStrand-ASD is a biochemical test intended to help health care providers rule out autism spectrum disorder (ASD) in children 1 month to 10 years of age. The test analyzes a strand of hair to map the dynamic patterns of an individual’s unique biological responses at a molecular level to environmental exposures over time and uses an algorithm to assess the likelihood of autism. It is not a genetic test and must be ordered by a licensed health care provider (Rx only). ClearStrand-ASD is performed at LinusBio's CLIA-certified laboratory (CLIA #31d2307499). For more information visit: https://www.clearstrandasd.com.
About LinusBio
LinusBio is pioneering exposomic sequencing to transform how we understand, diagnose, and treat disease. By decoding the dynamic interplay between genetics and the environment, LinusBio provides powerful insights to advance precision medicine. The company’s platform has already been applied to neurodevelopmental disorders, oncology, and chronic disease research, and is advancing the discovery of biomarkers for ALS and other conditions.
