Company’s ultra-sensitive biomarker technology supports milestone achievement in establishing a method for clinicians to identify and interpret elevated values of sNfL in individual patients

Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis with the goal of advancing the science of precision health, today announced its Simoa® technology supported a large international and comprehensive study to establish reference ranges of sNfL to assess disease activity and drug response in MS patients at the individual level, according to a recent study published in The Lancet Neurology. Researchers from the University Hospital Basel and University of Basel, led by Professor Jens Kuhle, leveraged Simoa’s ability to precisely detect the sNfL protein at ultra-low levels, enabling a large-scale international study in which sNfL could be reliably measured across a spectrum of normal healthy individuals.

“By utilizing Simoa’s ultra-sensitivity, our research team has been able to reach this milestone achievement for the larger MS community,” said Jens Kuhle, Professor and Head of the Neuroimmunology Unit and Multiple Sclerosis Center at the University Hospital Basel. “Our hope is that this breakthrough will establish a new method to help clinicians measure and interpret elevated values of sNfL to more precisely assess disease activity and drug response for MS patients. Serum NfL is a first example and there is high and realistic hope of future additional blood biomarkers informing personalized and more precise treatment decisions in MS.”

The study, “Serum neurofilament light chain for individual prognostication of disease activity in people with multiple sclerosis: a retrospective modelling and validation study,” is the most comprehensive to-date, examining over 20,000 samples from a diverse set of donors that spanned different age groups and body mass indexes, factors known to affect sNfL values, and two large MS cohorts. Because of the diverse patient set, this study helped establish a statistically robust reference database, along with a new method to support clinicians when interpreting results of sNfL levels in blood. This new method, which was validated and developed into an internet-based app, has the potential to enable monitoring of the long-term effectiveness of disease-modifying therapies in a real-world setting.

“sNfL measurements represent an important opportunity to advance the management of MS patients,” said Kevin Hrusovsky, Chairman and Chief Executive Officer, Quanterix and Founder of Powering Precision Health (PPH). “Other research utilizing our Simoa sNfL blood-based assay shows promise for prognostic information on the likelihood of relapse and for routine monitoring of disease activity. These advances could lead to improved and timelier optimization of therapy, but transition to the clinic requires the interpretation of sNfL values in individual patients. This seminal normative study provides practitioners with important insights on what level of sNfL represents ‘normal’.”

This news comes on the heels of the recent consensus guidelines that were published regarding how to use sNfL in MS management by Consortium of Multiple Sclerosis Centers (CMSC). As a result of the growing need for consensus guidelines for clinical use of NfL blood testing in MS, CMSC convened an international panel of 25 experts at the forefront of neurofilament research and clinical applications in MS. The panel met in two consensus conferences in 2020 to develop a comprehensive overview of available data, determine practical applications of this data in MS and debate confounding information and unanswered questions. These consensus guidelines were published last year in a dedicated issue of the International Journal of MS Care with an aim to inform the MS community about how to apply and interpret this promising biomarker in MS research and clinical practice.

For more information on Quanterix’ role in aiding MS research, visit: https://www.quanterix.com/therapeutic-areas/neurology/.

To learn more about Quanterix’ Simoa® technology, visit: https://www.quanterix.com/technology.

About Quanterix

Quanterix is a company that’s digitizing biomarker analysis with the goal of advancing the science of precision health. The company’s digital health solution, Simoa, has the potential to change the way in which healthcare is provided today by giving researchers the ability to closely examine the continuum from health to disease. Quanterix’ technology is designed to enable much earlier disease detection, better prognoses and enhanced treatment methods to improve the quality of life and longevity of the population for generations to come. The technology is currently being used for research applications in several therapeutic areas, including oncology, neurology, cardiology, inflammation and infectious disease. The company was established in 2007 and is located in Billerica, Massachusetts. For additional information, please visit https://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’ 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’ actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Quanterix’ 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/20220404005919/en/