The Elecsys NfL test measures a protein associated with nerve cell injury to monitor disease activity in patients with relapsing remitting multiple sclerosis.

Roche has received the CE mark for its Elecsys Neurofilament Light Chain (NfL) for the detection of neuroinflammation in adults diagnosed with relapsing remitting multiple sclerosis (RRMS). The immunoassay provides a minimally invasive method to monitor the biological damage associated with the disease.

Multiple sclerosis is a chronic condition affecting more than 2.9 million people worldwide. While magnetic resonance imaging (MRI) is the standard of care for monitoring disease activity, access to routine scanning can be limited by geographic, financial, or logistical barriers. The Elecsys NfL test measures NfL, a cytoskeletal protein found in neurons that is released during nerve cell injury.

“This approval marks a transformative step forward in how we support adults with RRMS,” says Matt Sause, chief executive officer of Roche Diagnostics, in a release. “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.”

Clinical Utility of NfL

NfL is a sensitive indicator of neuroaxonal damage. While the protein is released at low levels under normal conditions, concentrations increase with age and following nerve damage. Elevated NfL levels can be measured in both cerebrospinal fluid and blood in several acute and chronic neurological disorders.

By measuring these biological markers, the test offers insights that complement routine clinical assessments and MRI, potentially aiding in earlier clinical intervention. Because the test requires only a simple blood sample, collections can be performed locally, reducing the need for patients to travel to specialist centers for monitoring.

Laboratory Implementation

The Elecsys NfL test is performed on Roche’s cobas instruments, which are widely available in clinical laboratories. This platform is designed to provide standardized and consistent results across different testing locations.

The test previously received Breakthrough Device Designation from the US Food and Drug Administration (FDA) in November 2023. Following the CE mark approval, broad access to the testing will be available in countries that accept the designation through existing laboratory instrumentation.

Roche is also investigating more than a dozen other medicines and diagnostic tools for neurological conditions, including Alzheimer’s disease, Parkinson’s disease, and spinal muscular atrophy.

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