Breakthrough Study by LinusBio Suggests Path to First Biochemical Biomarker for ALS, Detected in a Single Hair Strand

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NORTH BRUNSWICK, N.J.--(BUSINESS WIRE)--Sep 9, 2025--

LinusBio, a leader in exposomic sequencing and precision health, today announced the publication of a study in The Lancet’s eBioMedicine that demonstrates a path toward the first-ever noninvasive, hair-based biomarker for amyotrophic lateral sclerosis (ALS).

The study shows that time-sequenced elemental patterns in single strands of hair, particularly copper-related relationships, are consistently different in individuals with ALS compared to controls. While not yet clinically validated, the findings provide critical evidence that a hair-based biomarker could one day give drug developers a powerful, objective tool for designing and running clinical trials more effectively and speeding the development of targeted therapies.

ALS, a progressive neurodegenerative disease that is also referred to as Lou Gehrig’s disease, is estimated to affect 30,000 Americans with 5,600 new diagnoses each year, according to the ALS Association. The condition remains a major challenge for drug developers because no reliable biomarker exists. Clinical trials still rely on symptom-based scales that are slow to change and often subjective, limiting the ability to measure therapeutic impact. Average survival following diagnosis is about three years, with only 20% of patients reaching five years and fewer than 10% living beyond 10 years. A validated biomarker could provide a quantitative trial endpoint, enable earlier and more accurate patient stratification, and accelerate the path to new therapies, while also reducing today’s 10 to 16 month diagnostic delays.

“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 study was conducted by investigators from 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. Researchers analyzed hair samples from nearly 400 participants, measuring 17 elements along single strands with 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.”

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.

About LinusBio

LinusBio (Linus Biotechnology Inc.) is a patient-centric, breakthrough science precision exposome medicine company headquartered in North Brunswick, NJ. The Company’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 (autism spectrum disorder, amyotrophic lateral sclerosis), gastroenterology (inflammatory bowel disease), renal disease and oncology.

For more information, visit www.linusbio.com.

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SOURCE: Linus Biotechnology Inc.

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PUB: 09/09/2025 07:58 AM/DISC: 09/09/2025 07:57 AM

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