Quanterix Validates Dual Blood Biomarker Test for Comprehensive Multiple Sclerosis Monitoring
核心洞察
A landmark study published in Brain journal validates that combined GFAP (搜索) and NfL (搜索) blood biomarkers provide comprehensive monitoring of multiple sclerosis (搜索) disease activity and progression.
Elevated serum GFAP (搜索) levels were significantly associated with increased risk of Progression Independent of Relapse Activity (PIRA), addressing the "biggest unmet therapeutic need in MS."
Quanterix's Simoa technology enables simultaneous measurement of both biomarkers with extensive normative databases for individual patient interpretation.
Quanterix Corporation (搜索) announced the publication of a landmark study in the journal Brain that validates a dual blood biomarker approach for comprehensive multiple sclerosis (搜索) (MS) monitoring. The research demonstrates that multiplexed Simoa assays for Glial Fibrillary Acidic Protein (搜索) (GFAP (搜索)) and Neurofilament Light Chain (搜索) (NfL (搜索)) establish a robust, complementary two-pronged approach for MS disease activity and progression monitoring.
Breakthrough in MS Progression Monitoring
The study, led by Professor Jens Kuhle from the University Hospital Basel (搜索) and University of Basel, reveals that these two serum biomarkers provide distinct and critical insights into the MS disease course. The research found that elevated serum GFAP (搜索) levels were significantly associated with an increased risk of Progression Independent of Relapse Activity (PIRA)—the slow, progressive deterioration that is difficult to detect with traditional monitoring methods.
This finding addresses a critical gap in MS care, as the paper notes PIRA represents the "biggest unmet therapeutic need in MS." The study also confirmed the established role of serum NfL (搜索) as the gold standard for predicting future relapses and monitoring acute disease activity.
"The long-term course of MS involves focal lesion activity and diffuse brain neurodegenerative processes," said Professor Kuhle. "While NfL (搜索) is an established biomarker of the former, there has been an urgent need for a biomarker that specifically reflects and predicts chronic progression independent of acute activity. Our study shows that serum GFAP (搜索) addresses this need and, when combined with NfL and interpreted using the accompanying normative data, provides a more comprehensive assessment of disease severity and progression risk for personalized patient management."
Precision Medicine Through Normative Data Infrastructure
A core component enabling these findings are extensive Simoa-based normative reference databases for both GFAP (搜索) and NfL (搜索). These unprecedented databases, generated from thousands of individuals, are essential for translating test results into meaningful clinical action for individual patients. Because GFAP and NfL values are significantly dependent on age and BMI (for GFAP also sex), the use of absolute cut-off values is unreliable and less informative for individual patients.
The comprehensive approach combines highly sensitive assays into a single blood test, large-scale normative data, and an interpretive tool to create what the company describes as a unique ecosystem towards precision medicine in MS. Clinicians can access a free, readily available online tool for interpretation of an individual patient's results along with age, sex, and BMI to accurately assess a patient's biomarker status and risk of progression.
Clinical Implementation and Drug Development Insights
The study, titled "GFAP (搜索) and NfL (搜索) as Predictors of Disease Progression and Relapse Activity in Fingolimod Treated Multiple Sclerosis (搜索)," utilized the automated HD-X instrument and the 2-plex kit that measures NfL and GFAP simultaneously (Simoa Neurology 2-Plex B). The ability to monitor both acute inflammatory activity (NfL) and insidious disease progression (GFAP) offers clinicians a more complete picture of an individual patient's status and risk.
Additionally, the observation that GFAP (搜索) levels decreased under fingolimod treatment suggests a potential novel mechanism of action for this class of drug, opening new avenues for drug development and monitoring using the GFAP assay.
"Serum NfL (搜索) measurements, pioneered by our technology and supported by extensive published research, are materially advancing the clinical management of MS patients," said Masoud Toloue, CEO at Quanterix. "This impressive work by Professor Kuhle and colleagues on integrating GFAP (搜索) and NfL solidifies a new avenue for improving personalized therapy for MS patients. Our platform's ability to deliver both highly sensitive assays in a single multiplexed test along with the necessary normative data infrastructure makes these results immediately actionable for providers, offering a truly best-in-class approach to MS management."
Technology Platform and Market Position
Quanterix's proprietary Simoa technology delivers industry-leading sensitivity, allowing researchers to detect and quantify biomarkers in blood and other fluids at concentrations far below traditional limits. With approximately 6,000 peer-reviewed publications, Quanterix has been a trusted partner to the scientific community for nearly two decades. In 2025, Quanterix acquired Akoya Biosciences (搜索), adding multiplexed tissue imaging with single-cell resolution to its portfolio and 1,396 installed instruments.