Roche Introduces Minimally Invasive Blood Test to Detect Neuroinflammation in Relapsing Remitting Multiple Sclerosis

Roche Introduces Minimally Invasive Blood Test to Detect Neuroinflammation in Relapsing Remitting Multiple Sclerosis

(IN BRIEF) Roche has obtained CE mark approval for its Elecsys Neurofilament Light Chain blood test, which detects neuroinflammation in patients with relapsing-remitting multiple sclerosis. The minimally invasive test measures biomarkers of nerve damage, offering an alternative to traditional monitoring methods like MRI scans. By improving accessibility and enabling more frequent assessments, the test aims to support earlier intervention and more personalized disease management for millions of patients worldwide.

(PRESS RELEASE) BASEL, 13-Apr-2026 — /EuropaWire/ — Roche has received CE mark approval for its Elecsys® Neurofilament Light Chain (NfL) blood test, introducing a new approach to detecting neuroinflammation in adults diagnosed with relapsing-remitting multiple sclerosis (RRMS). The test offers clinicians a minimally invasive method to monitor disease activity by identifying neuroaxonal damage linked to inflammation in the nervous system.

The Elecsys NfL test works by measuring neurofilament light chain, a protein released into the bloodstream when nerve cells are damaged. By analyzing this biomarker, the test provides insight into underlying neuroinflammatory processes associated with multiple sclerosis, supporting more informed clinical decision-making.

Multiple sclerosis affects more than 2.9 million people globally and requires continuous monitoring to manage disease progression effectively. However, traditional methods such as MRI scans can be resource-intensive and may not always be easily accessible for all patients. The new blood-based test complements these standard diagnostic tools by offering an additional layer of biological insight, potentially enabling earlier detection of disease activity and more timely adjustments to treatment.

Matt Sause, CEO of Roche Diagnostics, emphasized the significance of the approval, noting that the test represents a step forward in improving patient access to monitoring. He highlighted that a simple blood test can help reduce reliance on more complex imaging procedures and support more frequent and convenient assessments for individuals living with RRMS.

Designed for use on Roche’s cobas diagnostic platforms, the Elecsys NfL test delivers standardized and consistent results across different healthcare settings. Because it requires only a routine blood sample, testing can be performed locally, minimizing the need for patients to travel to specialized centers and reducing logistical barriers associated with disease monitoring.

By enabling broader access to regular monitoring and providing deeper insight into neuroinflammatory activity, the Elecsys NfL test has the potential to enhance disease management, support earlier clinical intervention, and contribute to more personalized care for people living with multiple sclerosis.

About NfL
Neurofilament Light Chain (NfL) is an abundant cytoskeletal protein4 found almost exclusively in neurons5 and is a sensitive indicator of neuroaxonal damage2,6. Under normal conditions, NfL is released at low levels from axons4; however, release increases with age7 and following neuroaxonal damage.4 Consequently, abnormally elevated NfL concentrations can be measured in cerebrospinal fluid and blood in a range of acute and chronic neurological disorders.2, 4, 6

About Elecsys® NfL
Roche’s Elecsys NfL is an in vitro quantitative immunoassay for the measurement of NfL protein in human serum and plasma. Elecsys NfL is intended to be used to reflect neuroinflammation in adult subjects diagnosed with relapsing-remitting multiple sclerosis.2

The test was granted Breakthrough Device Designation by the US FDA in November 2023. Following CE Mark approval, broad access to testing will exist through the large number of instruments currently available in countries accepting CE mark.

About Roche in neurology
Neurology is a major focus of research and development at Roche. Our goal is to pursue groundbreaking science to develop new diagnostics and treatments that help improve the lives of people with chronic and potentially devastating diseases globally.

Roche is investigating more than a dozen medicines for neurological conditions, including multiple sclerosis, spinal muscular atrophy, neuromyelitis optica spectrum disorder, Alzheimer’s disease, Huntington’s disease, Parkinson’s disease and Duchenne muscular dystrophy. Roche Diagnostics has developed a broad range of approved and investigational tools, including digital and blood-based tests and Cerebrospinal Fluid (CSF) assays, aiming to more effectively detect, diagnose and monitor neurological conditions.

Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neurology today.

About Roche
Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions.

Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them.

Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] Roche Diagnostics GmbH. Elecsys NfL. Method Sheet 09880488500 V1.0. Roche Diagnostics GmbH; 2025.
[2] Khalil M, et al. Nat Rev Neurol 2018;14:577–89. https://doi.org/10.1038/s41582-018-0058-z
[3] Bar-Or A, et al. EBioMedicine 2023;93:104662. https://doi.org/10.1016/j.ebiom.2023.104662
[4] Gaetani L, et al. J Neurol Neurosurg Psychiatry 2019;90:870–81. https://doi.org/10.1136/jnnp-2018-320106
[5] Gafson AR, et al. Brain 2020;143:1975–98. https://doi.org/10.1093/brain/awaa098
[6] Freedman MS, et al. EBioMedicine 2024;101:104970. https://doi.org/10.1016/j.ebiom.2024.104970
[7] Itorralba J, Schneider R. Pract Neurol (US) 2024;23(2):18–21. https://practicalneurology.com/diseases-diagnoses/ms-immune-disorders/the-prognostic-utility-of-neurofilament-light-chain-in-multiple-sclerosis-a-narrative-review/32098/
[8] MS International Federation. Atlas of MS: Number of people with MS. Accessed 1 April 2026. https://atlasofms.org/map/global/epidemiology/number-of-people-with-ms

Media Contacts:

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Roche Investor Relations

Investor Relations North America

SOURCE: Roche