LinusBio has introduced ClearStrand-ASD, an advanced biomarker test that supports the early detection of autism spectrum disorder (ASD) in children aged one to 36 months.
ClearStrand-ASD is an advanced biomarker test that analyses a single strand of hair to identify a molecular signature predictive of autism.
It provides a negative predictive value (NPV) of 92.5% and helps healthcare providers identify children who are unlikely to be on the autism spectrum.
The diagnostic test aims to help healthcare providers rule out ASD earlier and enable timely intervention and evaluation by an autism specialist.
LinusBio CEO and founder Manish Arora said: “With the rise in autism prevalence, earlier diagnosis and intervention in children’s formative years have become critical public health priorities.
“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.”
According to the company, the ClearStrand-ASD test analyses a patient’s metabolism of essential and non-essential elements over time.
It leverages LinusBio’s unique platform, which deploys advanced robotics and lasers in an advanced CLIA-regulated facility, to generate thousands of data points from a hair sample.
The test applies AI and machine learning technologies to analyse the data points generated for each patient and identify the biomarkers associated with ASD.
ClearStrand-ASD test is intended for children at high risk, such as those born preterm, with a sibling diagnosed with ASD, or displaying characteristics linked to the condition.
John Carroll University psychology professor, and prominent autism clinical researcher Thomas Frazier said: “In the US, 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.
“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.”
