LinusBio has announced a significant breakthrough in amyotrophic lateral sclerosis (ALS) research with the publication of a study in The Lancet's eBioMedicine demonstrating a path toward the first-ever noninvasive, hair-based biomarker for the neurodegenerative disease. The research shows that time-sequenced elemental patterns in single hair strands, particularly copper-related relationships, are consistently different in individuals with ALS compared to controls.
Novel Biomarker Discovery
The study, conducted by investigators from Icahn School of Medicine at Mount Sinai, Linus Biotechnology, Dartmouth University, and Columbia University, analyzed hair samples from nearly 400 participants. Researchers measured 17 elements along single strands using high-resolution laser ablation–inductively coupled plasma mass spectrometry (LA-ICP-MS).
"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."
Addressing Critical Unmet Need
ALS affects an estimated 30,000 Americans with 5,600 new diagnoses each year, according to the ALS Association. The progressive neurodegenerative disease presents significant challenges for drug developers due to the absence of reliable biomarkers. Clinical trials currently rely on symptom-based scales that are slow to change and often subjective, limiting the ability to measure therapeutic impact.
The disease's prognosis remains dire, with average survival following diagnosis of about three years. Only 20% of patients reach five years and fewer than 10% live beyond 10 years. Current diagnostic delays range from 10 to 16 months, further complicating treatment efforts.
Clinical Trial Applications
While not yet clinically validated, the findings provide critical evidence that a hair-based biomarker could give drug developers a powerful, objective tool for designing and running clinical trials more effectively. A validated biomarker could provide a quantitative trial endpoint, enable earlier and more accurate patient stratification, and accelerate the path to new therapies.
"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."
Research Support and Future Development
The study received support from the National Institutes of Health and the Centers for Disease Control and Prevention. LinusBio is actively advancing this work and expects to publish additional research by the end of the year. The company's approach has the potential to change the landscape for ALS therapy development and dramatically improve the diagnostic journey for patients.
LinusBio's program pipeline comprises precision exposome medicine biomarkers and target discovery across disease domains for which historically no molecular endpoints have been available in medical practice or for clinical trials, including CNS disorders, gastroenterology, renal disease, and oncology.
