Quanterix’s ultra-sensitive Simoa assay has the potential to open new uses for the brain biomarker known as neurofilament light chain, including the possibility to detect early evidence of neurological diseases like multiple sclerosis (MS), Parkinson’s, and Alzheimer’s, and ably evaluate efforts to treat and prevent them, the company reports in a press release.
A hallmark of MS is the progressive degeneration of brain cells. As these cells are damaged, a protein called neurofilament light chain, or NfL, is released into cerebral spinal fluid and blood.
Studies have suggested that blood levels of NfL provide a reliable picture of MS activity, and could also be used to monitor disease progression, instead of magnetic resonance imaging scans of the brain. However, NfL’s use as a diagnostic marker for MS and other neurological disorders was limited due to lack of sensitive and reliable methods to assess it.
The Simoa assay may give researchers that ability, allowing them to quickly and efficiently measure NfL in the blood, transforming protein levels into a critical biomarker of precision health — and one more predictive of likely disease activity that MRI scans.
“NfL is rapidly emerging as a critical biomarker providing novel insights into an incredibly wide range of applications, and its potential to impact healthcare is staggering,” Kevin Hrusovsky, CEO, president and chairman of Quanterix, said in the release.
“Using Simoa, researchers are now, for the first time, able to measure NfL in blood, vastly expanding the number and breadth of studies possible and providing insights into disease progression, patient response and drug performance, and accelerating drug development that was never possible before,” added Hrusovsky, who is also founder of Powering Precision Health.
Using the Simoa assay, researchers at the University of Basel, Switzerland, recently showed that NfL blood levels are higher in patients with MS than in healthy volunteers. They used serum samples from 259 MS patients — including 70 with progressive disease — and an equal number of healthy people, and followed patients for a median of 6.5 years.
NfL blood levels were also found to be an independent predictor of worsening MS disability over the following year. Patients with the highest NfL values had the worse disability scores (assessed by the Expanded Disability Status Scale, EDSS) at the next clinical visit.
Higher NfL values also correlated with more pronounced brain and spinal cord volume loss and lesion progression — high blood levels were associated with an additional average loss in brain volume of 1.5% and spinal cord volume of 2.5% over five years, the study reported.
“Serum neurofilament light chain correlated with concurrent and future clinical and MRI measures of disease activity and severity,” the researchers wrote. “NfL levels are a real-time, easy to measure marker of neuro-axonal injury that is conceptually more comprehensive than brain MRI.”
These findings were published in the journal Brain, in the study “Serum neurofilament as a predictor of disease worsening and brain and spinal cord atrophy in multiple sclerosis.”
Supported by this and other studies, NfL levels determined by the Simoa assay are showing potential to be a viable biomarker that could be used as an endpoint measure for drug development and clinical trial assessment.
According to Hrusovsky, MS patients undergo on average 1.5 MRI scans per year, “these scans, however, measure brain atrophy, which is a very late stage measurement of the disease.”
“Biomarkers like NfL can change the practice of medicine, enabling us to catch diseases earlier, identify impactful treatment methods faster, and check to ensure a drug is having the desired impact,” Hrusovsky concluded.
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