By Diagnostics World Staff
February 13, 2025 | Last week, LinusBio announced the launch of ClearStrand-ASD, a first-of-its-kind diagnostic aid for autism spectrum disorder (ASD). The test was discussed last year by LinusBio CEO and founder Manish Arora, who told Diagnostics World of his company’s “exposomics” platform.
“ClearStrand-ASD examines patterns in how a person’s body processes certain elements, which can be measured in their hair,” Arora said in a press release announcing the product. “These patterns, known as the ‘biomarker,’ differ between autistic and non-autistic individuals.”
ClearStrand-ASD analyzes a single strand of hair using proprietary robotics and lasers in a CLIA-regulated facility. Using AI and ML, the test then analyzes hundreds of time points along the strand and then applies an algorithm that assesses the likelihood of autism. The biomarker reflects molecular patterns that indicate how a child’s body metabolizes both essential and non-essential elements, which varies between autistic and non-autistic individuals, according to Arora. So far, ClearStrand-ASD has produced a 92.5% negative predictive value, which can help physicians identify children who are unlikely to be on the autism spectrum.
The team initially conducted their research with teeth, but children don’t start losing baby teeth until age 5 or 6. By then, ASD has already set in, which makes treatment and therapy more difficult. Early intervention between ages 1-3 has proven to considerably improve language and social skills, and they wanted something less invasive, more pragmatic, and didn’t have a long waiting period.
“Hair strands are like a biological hard drive,” explains Arora. “They provide a chronological record of an individual's metabolism of various essential nutrients and toxic compounds.” With ClearStrand-ASD, it is now possible for babies as young as one month to get tested for the biomarker.
ClearStrand-ASD is now available in 44 states. The algorithm will continue to be refined as more real-world data is gathered in order to ensure accuracy and reliability.
“We envisage that our platform will help monitor our patients’ progress as they receive therapy, identify subtypes of autism, and also help develop new treatments,” says Arora. “We are also focused on working with payors on pricing and to increase access to ClearStrand-ASD so that more families can benefit from this test.”