NORTH BRUNSWICK, N.J.– LinusBio, a company focused on exposomic sequencing and precision health, announced the publication of a study in The Lancet’s eBioMedicine that suggests a path toward the first noninvasive, hair-based biomarker for amyotrophic lateral sclerosis (ALS).
The study found that time-sequenced elemental patterns in single strands of hair, particularly copper-related relationships, were consistently different in individuals with ALS compared to controls. While not yet clinically validated, the findings provide evidence that a hair-based biomarker could give drug developers an objective tool to design and evaluate clinical trials more effectively, accelerate the development of targeted therapies, and enable earlier diagnosis.
ALS, also known as Lou Gehrig’s disease, affects an estimated 30,000 Americans, with 5,600 new diagnoses each year. The disease progresses rapidly, with average survival at about three years. Because no reliable biomarker currently exists, clinical trials rely on symptom-based scales that are subjective and slow to change, making it difficult to measure therapeutic impact. A validated biomarker could help reduce diagnostic delays, improve patient stratification, and provide quantitative trial endpoints.
“ALS drug development has long been held back by the absence of reliable biochemical markers,” said Dr. Manish Arora, founder and CEO of LinusBio. “A validated, biochemical test could give drug developers a quantitative endpoint for clinical trials, shortening timelines and enabling more targeted therapies. For patients, it could also mean earlier diagnosis and faster access to treatment.”
The research was conducted by scientists from the Icahn School of Medicine at Mount Sinai, Linus Biotechnology, Dartmouth University, and Columbia University, with support from the National Institutes of Health and the Centers for Disease Control and Prevention. Hair samples from nearly 400 participants were analyzed using high-resolution laser ablation–inductively coupled plasma mass spectrometry to measure 17 elements along single strands.
“Our study shows that hair contains a detailed elemental record that reflects disease processes over time,” said Dr. Vishal Midya, Assistant Professor of Environmental Medicine and Public Health at the Icahn School of Medicine at Mount Sinai. “By applying sophisticated computational methods, we uncovered consistent patterns in ALS patients that were invisible to conventional approaches. This proof-of-concept opens an entirely new window for ALS research and drug development.”
LinusBio said it is continuing to advance this work and expects to publish additional findings later this year, with the goal of transforming ALS therapy development and improving the diagnostic journey for patients.
