Quanterix Announces Landmark Study Demonstrating Dual GFAP/NfL Blood Test Approach for Personalized Multiple Sclerosis Monitoring

Publication in the journal ‘Brain' confirms complementary roles of the biomarkers for predicting relapse and chronic disability progression in multiple sclerosis (MS)

Simoa technology paired with an extensive Simoa-derived normative data infrastructure enable individual patient interpretation, addressing a critical unmet need for full spectrum MS disease 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.

About Quanterix

Quanterix is a global leader in ultra-sensitive biomarker detection, enabling breakthroughs in disease research, diagnostics, and drug development. Its 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, The Spatial Biology Company®, adding multiplexed tissue imaging with single-cell resolution to its portfolio and 1,396 installed instruments. Together, the combined company offers a uniquely integrated platform that connects biology across blood and tissue—advancing precision medicine from discovery to diagnostics. Learn more at www.quanterix.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this news release are based on Quanterix's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause Quanterix's actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Quanterix's filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein. Except as required by law, Quanterix assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

View source version on businesswire.com: https://www.businesswire.com/news/home/20251117284338/en/

Study Media Contact:

Prof. Dr. med. Dr. phil. Jens Kuhle

Head Multiple Sclerosis Centre and Neuroimmunology Unit

Research Centre for Clinical Neuroimmunology and Neuroscience Basel (RC2NB)

Neurology

Departments of Biomedicine and Clinical Research

[email protected]

Quanterix Media Contact:

[email protected]

Investor Relations Contact:

Joshua Young

(508) 846-3327 - mobile

[email protected]