First-ever diagnostic aid to provide biochemically measurable insights about autism as early as one month of age
Data to be presented at the Metabolomics and Human Health Conference GRC
NORTH BRUNSWICK, N.J.--(BUSINESS WIRE)--LinusBio, a leader in precision exposome medicine, today announced ClearStrand-ASD™, a first-of-its-kind diagnostic aid for autism spectrum disorder (ASD). ClearStrand-ASD is a biochemical test that identifies a molecular signature predictive of autism in a strand of hair. It is designed to help physicians rule out the condition in children between one and 36 months of age when autism is a concern. The test provides a negative predictive value (NPV) of 92.5% and can help providers identify children who are unlikely to be on the autism spectrum. Results may help inform decisions to refer a child for early intervention and for diagnostic evaluation by an autism specialist.
ClearStrand-ASD performance validation data will be presented at the Metabolomics and Human Health Conference GRC. The abstract, titled “A biochemical rule-out test for autism spectrum disorder”, will be presented on February 2-7, 2025.
“With the rise in autism prevalence, earlier diagnosis and intervention in children’s formative years have become critical public health priorities,” said Manish Arora, Ph.D., CEO and founder of LinusBio. “Families today often endure exhausting journeys to secure a diagnosis for their child, and this is what we aim to change. 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.”
ClearStrand-ASD is a first-in-class biomarker test that analyzes an individual’s metabolism of essential and non-essential elements over time. LinusBio’s platform analyzes a single strand of hair using proprietary robotics and lasers in a state-of-the-art CLIA-regulated facility. Thousands of data points are generated for each patient, and with the help of AI and machine learning, it becomes possible to identify whether a patient has the molecular signature – a biomarker – associated with ASD.
“In the U.S., the median age of a patient receiving an ASD diagnosis is about four years old—a delay that leaves many families waiting far too long for answers. 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, prominent autism clinical researcher, and parent of a young adult with autism. “In infants and young children, signs of autism can look like other conditions. ClearStrand-ASD has the potential to offer families and health care professionals critical insights as a biomarker-based diagnostic aid, empowering them to make informed decisions and pursue appropriate early interventions that can make a meaningful difference in a child’s life.”
ClearStrand-ASD must be ordered by a licensed health care provider. LinusBio enables caregivers to request the test from home through an independent telehealth provider. The test is intended for infants and toddlers who are at an elevated risk of autism, such as those who were born preterm, who have a sibling with autism, or who have demonstrated characteristics associated with autism. If the test does not detect the biomarker, it is unlikely the child has autism. If the test does find the biomarker, the child may need further professional evaluation. ClearStrand-ASD is available in 44 states (excluding CA, HI, MD, NY, RI, PA, and DC).
About ClearStrand-ASD
ClearStrand-ASD is a biochemical test intended to help health care providers rule out autism spectrum disorder (ASD) in children 1 to 36 months. 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 results can be negative or non-negative. A child with a negative result is unlikely to be on the autism spectrum. A child with a non-negative result may need further evaluation. ClearStrand-ASD is not a standalone diagnostic test. Health care providers should consider the test result along with other factors relevant to their clinical decision making. The test is performed by the LinusBio laboratory (CLIA #31d2307499) and has not been cleared or approved by the U.S. Food & Drug Administration (FDA). For more information, visit www.clearstrandasd.com.
About LinusBio
Linus Biotechnology Inc. (LinusBio) is a patient-centric precision exposomic medicine company based in North Brunswick, New Jersey. The company’s pipeline leverages exposomic data and target discovery across diseases that, historically, have had no molecular markers. These include: autism spectrum disorder, amyotrophic lateral sclerosis and other central nervous system conditions, as well as inflammatory bowel disease and oncology. For more information, visit www.linusbio.com.
Contacts
LinusBio Media Contact:
Rachel Ford Hutman
rachel@fordhutmanmedia.com
+1.301.801.5540
