LinusBio has expanded the availability of its ClearStrand-ASD test, extending its use from children under 48 months to those up to 10 years old. The test is a first-of-its-kind, noninvasive biochemical screening tool that requires only a single strand of hair—making it accessible even for infants as young as one month. The expansion is supported by a global study of 1,697 participants, with findings submitted for peer-reviewed publication.
Unlike traditional diagnostics that rely on genetics or behavioral assessments, ClearStrand-ASD is based on exposomics, a rapidly emerging field that studies how environmental exposures interact with human biology over time. Because hair grows continuously, it functions as a biological timeline, capturing a sequential record of metabolic and molecular activity. In a CLIA-certified laboratory, LinusBio uses proprietary robotics and laser-based technology to analyze hundreds of data points along the hair strand, identifying patterns that correlate with autism spectrum disorder.
The test is specifically designed as a rule-out screening tool, rather than a diagnostic replacement. Its clinical value lies in its ability to help physicians and families confidently exclude ASD as a likely condition. With 90% sensitivity and a 95% negative predictive value, the test provides a high degree of reassurance when results indicate a child is unlikely to have autism. This can help reduce uncertainty, guide next steps in care, and avoid delays in addressing other potential developmental or medical concerns.
The expansion to older children reflects growing data and improved understanding of the biological signals associated with ASD. LinusBio’s leadership emphasized that increasing access to objective, biology-based screening tools can complement traditional clinical evaluations, particularly in cases where diagnosis may be delayed or unclear. By extending the test to a broader age range, the company aims to support earlier and more informed decision-making across pediatric care settings.
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