Quanterix Publishes A Landmark Study In The Journal Brain; Study Demonstrates Dual GFAP/NfL Blood Test Approach for Personalized Multiple Sclerosis Monitoring

Quanterix Corporation(NASDAQ:QTRX), a company transforming healthcare by accelerating biomarker breakthroughs from discovery to diagnostics, today announced the publication of a landmark study in the high-impact journal Brain. The paper validates that multiplexed Simoa assays for Glial Fibrillary Acidic Protein (GFAP) and Neurofilament Light Chain (NfL) establish a robust, complementary two-pronged approach for comprehensive Multiple Sclerosis (MS) disease activity and progression monitoring.

The study, led by Professor Jens Kuhle from the University Hospital Basel and University of Basel, demonstrates that these two serum biomarkers provide distinct and critical insights into the MS disease course. The research found that elevated serum GFAP 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. This finding is particularly significant, as the paper notes PIRA represents the "biggest unmet therapeutic need in MS." The established role of serum NfL as the gold standard for predicting future relapses and monitoring acute disease activity was also confirmed. 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.

A core component enabling these findings are extensive Simoa-based normative reference databases for both GFAP and NfL. 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. With a free, readily available online tool for interpretation of an individual patient's results along with age, sex, and BMI, clinicians can accurately assess a patient's biomarker status and risk of progression. This comprehensive approach—combining highly sensitive assays into a single blood test, large-scale normative data, and an interpretive tool—creates a unique ecosystem towards precision medicine in MS.

"The long-term course of MS involves focal lesion activity and diffuse brain neurodegenerative processes," said Professor Kuhle. "While NfL 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 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."

"Serum NfL 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 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."

The study, "GFAP and NfL as Predictors of Disease Progression and Relapse Activity in Fingolimod Treated Multiple Sclerosis," utilized the automated HD-X instrument and the 2-plex kit that measures NfL and GFAP simultaneously (Simoa Neurology 2-Plex B). Additionally, the observation in the study that GFAP 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.