Global pharma giant 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). This marks a significant step toward simpler and more accessible disease monitoring.
The new test offers a minimally invasive blood-based approach to tracking neurological damage, measuring neurofilament light chain—a protein released when nerve cells are injured. By capturing this signal of neuroaxonal damage, the test provides clinicians with a clearer view of the neuroinflammation driving multiple sclerosis progression.
Multiple sclerosis affects more than 2.9 million people worldwide, and timely monitoring is critical for effective treatment.
However, access to MRI scans and routine specialist assessments can be limited. Roche’s Elecsys NfL test aims to fill that gap by adding a scalable, blood-based tool that can complement existing diagnostic methods and help clinicians detect disease activity earlier and more consistently.
“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.”
The test runs on Roche’s widely deployed cobas laboratory systems, delivering standardized and reproducible results across different settings. Because it requires only a routine blood sample, testing can be performed locally, reducing dependence on specialist centres and improving access for patients who may otherwise struggle to reach advanced imaging facilities.
Neurofilament light chain itself is a well-established biomarker of neuronal injury, found primarily in nerve cells and released into bodily fluids when axonal damage occurs. Elevated levels can signal ongoing neurological harm across a range of conditions, making it a valuable indicator of disease activity.
Roche’s Elecsys NfL is an in vitro quantitative immunoassay designed to measure NfL in serum and plasma, specifically intended to reflect neuroinflammation in adults diagnosed with RRMS.
As Roche expands its neurology portfolio, the company is positioning blood-based biomarkers as a practical alternative—and complement—to MRI, potentially reshaping how multiple sclerosis is monitored in routine clinical care.
_256_275.jpg)
