Breakthrough Autism Diagnostic Test Identifies Biomarker in Hair Samples

A new diagnostic test, ClearStrand-ASD, has been developed to identify autism spectrum disorder (ASD) in children as young as one year old. The test analyzes a single strand of hair using proprietary robotics and lasers, generating thousands of data points that help identify a molecular signature associated with ASD.

Developed by LinusBio, a precision exposome medicine company, ClearStrand-ASD provides a negative predictive value (NPV) of 92.5%, meaning it can effectively rule out autism in children between one and three years old when symptoms are present. The test is designed to help healthcare providers make informed decisions about early intervention and diagnostic evaluation.

According to Manish Arora, CEO and founder of LinusBio, the rise in autism prevalence has made earlier diagnosis and intervention critical public health priorities. ClearStrand-ASD aims to alleviate the exhaustion faced by families seeking a diagnosis for their child by providing an objective biomarker test that can help plan next steps earlier than ever before.

The test analyzes metabolism over time, identifying patterns associated with ASD in a patient’s hair. It has not been cleared or approved by the FDA but is available in 44 states and can be ordered by licensed healthcare providers through telehealth services.

Source: https://www.businesswire.com/news/home/20250206657653/en/Groundbreaking-Autism-Biomarker-LinusBio-Launches-ClearStrand-ASD-to-aid-Health-Care-Providers-in-Ruling-Out-Autism-Using-a-Single-Strand-of-Hair