Elecsys NfL Test Receives European Approval for Monitoring Neuroinflammation in Relapsing-Remitting Multiple Sclerosis

In a new company update, Roche has announced that its Elecsys neurofilament light chain (NfL) test has received CE mark approval for detecting neuroinflammation in patients with relapsing-remitting multiple sclerosis (RRMS). The company noted that the blood-based assay is designed to provide clinicians with a less invasive method to monitor disease-related nerve cell injury and support clinical decision-making.¹

“The CE mark for Elecsys NfL is an important moment for MS care, as it brings a CE‑marked blood test to detect neuroinflammation in relapsing‑remitting MS into everyday clinical practice. Clinicians can now access a standardised, in‑vitro diagnostic‑quality blood test that measures [NfL], a protein released during nerve cell injury, on widely used cobas instruments rather than relying only on specialised or research settings,” Ashton Harper, MD, Global Medical Affairs Lead for Neuroscience at Roche Diagnostics, told NeurologyLive^®. “From a medical perspective, this is highly encouraging. Using a simple blood test to measure NfL provides a picture of the neuroinflammation and neuroaxonal damage associated with MS, complementing routine clinical assessments and MRI. In this way, Elecsys NfL has the potential to support earlier and better‑informed clinical management and to contribute to more personalised care for people living with MS.”

Previously granted breakthrough device designation by the FDA, the Elecsys NfL test measures NfL, a protein released into the bloodstream during neuroaxonal damage.² By quantifying this biomarker through a simple blood draw, the test offers insight into the biological processes underlying neuroinflammation in MS. According to the company, this approach may complement existing tools such as MRI and clinical assessments by providing additional data on disease activity.

The CE mark approval positions the test as a potential option for broader clinical use in Europe, particularly in settings where access to routine MRI monitoring may be limited. Roche indicated that the test could support more frequent and accessible disease monitoring, which may be relevant for optimizing treatment strategies in RRMS. Further integration into clinical workflows will likely depend on adoption patterns and additional real-world evidence.

MS is a chronic neurological condition affecting more than 2.9 million individuals globally.¹ Disease monitoring plays a central role in managing RRMS, as timely detection of disease activity can inform treatment adjustments and potentially improve patient outcomes. However, traditional monitoring approaches, particularly MRI, may be associated with logistical, geographic, and financial barriers that limit their accessibility for some patients.

“For MS clinicians and their patients, Elecsys NfL offers a minimally invasive, accessible complement to the traditional standard of care by enabling more frequent monitoring of a patient’s neuroinflammatory status. By quantifying [NfL] as a sensitive indicator of neuroaxonal damage, the test provides an additional source of information that can be used alongside relapses, disability assessments and MRI in adults with relapsing‑remitting MS,” Harper added.

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The Elecsys NfL test is designed to address some of these challenges by enabling measurement of neuroaxonal injury through a minimally invasive blood test. This method provides a different type of clinical insight compared with imaging, focusing on biochemical markers of nerve cell damage associated with neuroinflammation. These biomarker-based assessments may offer an additional layer of information to complement structural imaging and clinical evaluation.

“Performed on Roche’s widely used cobas instruments, Elecsys NfL provides standardised and consistent results, supporting reliable insights regardless of where the test is carried out,” Harper said. “This combination of a blood‑based marker of neuroaxonal damage, IVD‑quality standardisation and broad availability on fully automated Roche instruments gives laboratories and clinicians a practical way to scale MS testing and to integrate biomarker‑based monitoring into existing workflows.”

Another potential advantage of the test is its accessibility. Because it requires only a blood sample, collection can be conducted in local health care settings, potentially reducing the need for patients to travel to specialized centers. This may help address disparities in access to monitoring, particularly for individuals in regions where MRI availability is limited or where repeated imaging poses practical challenges.

“This approval marks a transformative step forward in how we support adults with relapsing-remitting multiple sclerosis (RRMS),” Matt Sause, CEO at Roche Diagnostics, said in a statement.¹ “The availability of a simple blood-based test has the potential to complement resource-intensive MRI scans and improve access for patients with RRMS. The Elecsys NfL test will help healthcare providers support timely clinical reassessment, enabling better disease management and more personalised care for patients.”

Prior to this development, Roche had received multiple regulatory clearances for biomarker-based assays in neurodegenerative disease. In October 2025, the FDA cleared the company’s Elecsys p-tau181 test, representing the first blood-based biomarker assay authorized for use in primary care settings to support the assessment and diagnosis of Alzheimer disease (AD).³

Earlier, in June 2023, the agency granted 510(k) clearance for Roche’s cerebrospinal fluid–based Elecsys assays for AD, including beta-amyloid1-42 CSF II (Aβ42) and total tau (tTau).⁴ These approvals reflect the company’s ongoing efforts to expand the availability of biomarker-driven diagnostic tools across neurological conditions, spanning both blood- and cerebrospinal fluid–based approaches.

REFERENCES
1. Roche receives CE mark for new Elecsys NfL blood test to detect neuroinflammation in multiple sclerosis. News release. Roche. April 12, 2026. Accessed April 13, 2026. https://www.roche.com/media/releases/med-cor-2026-04-13
2. Roche’s Elecsys NfL test, an important tool for those living with multiple sclerosis, is granted FDA breakthrough device designation. News release. Roche. November 9, 2023. Accessed April 13, 2026. https://diagnostics.roche.com/us/en/news-listing/2023/roche-elecsys-nfl-test-granted-fda-breakthrough-device-designati.html
3. Roche’s Elecsys® pTau181 becomes the only FDA-cleared blood test for use in primary care to rule out Alzheimer’s-related amyloid pathology. News release. Roche. October 13, 2025. Accessed April 14, 2026. https://diagnostics.roche.com/us/en/news-listing/2025/fda-cleared-ptau181-alzheimers-blood-test.html
4. oche receives FDA clearance for additional Alzheimer’s disease cerebrospinal fluid (CSF) assays, supporting timely diagnosis and treatment decision-making. News release. June 27, 2023. Accessed April 14, 2026. https://diagnostics.roche.com/us/en/news-listing/2023/roche-fda-clearance-additional-alzheimers-disease-cerebrospinal-fluid-ttau.html