Roche announces CE mark for new Elecsys NFL blood test for MS

Roche has announced that its Elecsys^® Neurofilament Light Chain (NfL) test has received CE mark approval for the detection of neuroinflammation in patients diagnosed with relapsing remitting multiple sclerosis (RRMS)¹.

The test brings meaningful innovation to MS disease management, offering clinicians a minimally invasive way to monitor the biological damage caused by MS. Using a simple blood test to measure NfL – a protein released during nerve cell injury – Elecsys NfL provides a picture of the neuroinflammation associated with multiple sclerosis, and could help to make more regular monitoring a reality for more people living with the disease.

Early and regular monitoring of disease activity is critical to optimizing treatment, yet some patients can find it difficult to access routine assessments such as MRI scanning that would allow timely detection of changes in their condition. The Elecsys NfL test provides a different type of insight by measuring biological markers of neuroaxonal damage that reflect neuroinflammation. These insights complement routine clinical assessments and MRI, potentially aiding in earlier and better-informed clinical management.

Performed on Roche’s widely available cobas instruments, the Elecsys NfL test provides standardized and consistent results¹, ensuring reliable insights regardless of where the test is carried out. Requiring only a simple blood sample, collections can be done locally, reducing the need for patients to travel to specialist centers. With traditional testing for MS often limited by geographic, financial, or logistical barriers, Elecsys NfL makes frequent monitoring more practical and accessible.

“This approval marks a transformative step forward in how we support adults with relapsing-remitting multiple sclerosis (RRMS),” said Matt Sause, CEO of Roche Diagnostics. “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.”

References

1. Roche Diagnostics GmbH. Elecsys NfL. Method Sheet 09880488500 V1.0. Roche Diagnostics GmbH; 2025.

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