Roche’s Elecsys® NfL Test Wins CE Mark For Detecting Neuroinflammation In Relapsing-Remitting Multiple Sclerosis

Roche announced that its Elecsys Neurofilament Light Chain (NfL) test has received CE mark approval for detecting neuroinflammation in people diagnosed with relapsing-remitting multiple sclerosis (RRMS). This approval introduces an important advancement in how multiple sclerosis can be monitored, as the test offers clinicians a minimally invasive method to track biological damage caused by the disease. By measuring NfL — a protein released when nerve cells are damaged — through a simple blood test, Elecsys NfL provides insight into the neuroinflammation associated with MS and may support more frequent monitoring for patients.

Multiple sclerosis is a long-term neurological condition that affects more than 2.9 million people globally. Early and regular monitoring is essential for guiding treatment decisions, but many patients face challenges in accessing routine tests such as MRI scans, which help detect changes in disease activity. The Elecsys NfL test offers a different source of clinical information by measuring biological markers that indicate neuroaxonal damage. These insights work alongside standard clinical assessments and MRI findings, potentially supporting earlier interventions and better-informed care decisions.

Matt Sause, CEO of Roche Diagnostics, noted that the CE mark approval represents a major step forward in supporting adults living with RRMS. He explained that having a straightforward blood-based test can complement MRI scans, which are often resource-intensive and not always easily accessible. He added that Elecsys NfL can help healthcare professionals identify when a patient may need clinical reassessment, enabling more timely management and more personalised treatment approaches.

The Elecsys NfL test runs on Roche’s widely used cobas instruments, ensuring consistent and standardised results regardless of where the test is conducted. Because it only requires a basic blood sample, patients can have it collected at local facilities rather than travelling to specialised centres. In situations where traditional monitoring for multiple sclerosis may be limited by distance, financial constraints, or a lack of resources, the availability of Elecsys NfL can make more frequent and accessible monitoring a practical reality for many people living with the condition.